Cinnamomum zeylanicum (Ceylon cinnamon) as a potential pharmaceutical agent for type-2 diabetes mellitus: study protocol for a randomized controlled trial View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2017-09-29

AUTHORS

Priyanga Ranasinghe, Priyadarshani Galappaththy, Godwin Roger Constantine, Ranil Jayawardena, Hasitha Dhananjaya Weeratunga, Sirimal Premakumara, Prasad Katulanda

ABSTRACT

BackgroundPrevious studies have explored the anti-diabetic effects of Cinnamomum cassia extract in vivo and in vitro. However, there are no studies at present exploring the effects of the indigenous species of Sri Lankan cinnamon (Cinnamomum zeylanicum) in patients with diabetes mellitus. The present study aims to evaluate the potential effects of Cinnamomum zeylanicum extract as a pharmaceutical agent in patients with type-2 diabetes mellitus.Methods/designThe study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 4 months at the Medical Clinic, University Medical Unit, National Hospital of Sri Lanka. A total of 210 subjects with diabetes, in three equal groups, will be recruited for the study. The patients will be randomized in a 1:1:1 ratio according to the method of block randomization and the subjects will be randomly and equally assigned into two test groups (n = 70 each) and one placebo group (n = 70). The population will be stratified at randomization based on age, gender and disease severity. The treatment drug is a capsule containing Cinnamomum zeylanicum extract as the active ingredient and the placebo capsule will contain lactose monohydrate. Two doses of Cinnamomum zeylanicum extracts (250 mg and 500 mg of the cinnamon extract) will be used. The study drugs will be double blinded to both investigators and participants. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 2 months (visit 2), 3 months (visit 3) and 4 months (visit 4). The following primary outcome measures will be evaluated: glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG) and serum insulin. Secondary outcome measures include: Body Mass Index (BMI) and other anthropometric parameters, blood pressure, total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL) and triglycerides (TAG). Data will be analyzed using SPSS version 14.DiscussionWe describe the protocol for a clinical trial design evaluating the effects of Cinnamomum zeylanicum (Ceylon cinnamon) in patients with type-2 diabetes mellitus. The result of the present study, positive or negative, should provide a step change in the evidence guiding current and future policies regarding the use of cinnamon dietary supplementation in patients with diabetes.Trial registrationSri Lanka Clinical Trials Registry (SLCTR), identifier: SLCTR/2017/010 (http://slctr.lk/trials/714). Registered on 5 April 2017; study protocol version 3.1 21 March 2017. More... »

PAGES

446

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s13063-017-2192-0

DOI

http://dx.doi.org/10.1186/s13063-017-2192-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1091991393

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28962661


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1103", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Clinical Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Adolescent", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Adult", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Aged", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Biomarkers", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Blood Glucose", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Cinnamomum zeylanicum", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Clinical Protocols", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Diabetes Mellitus, Type 2", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Double-Blind Method", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Female", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Glycated Hemoglobin A", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Humans", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Hypoglycemic Agents", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Insulin", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Male", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Middle Aged", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Plant Extracts", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Research Design", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Severity of Illness Index", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Sri Lanka", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Time Factors", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Treatment Outcome", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Young Adult", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka", 
          "id": "http://www.grid.ac/institutes/grid.8065.b", 
          "name": [
            "Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Ranasinghe", 
        "givenName": "Priyanga", 
        "id": "sg:person.0715170063.93", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0715170063.93"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka", 
          "id": "http://www.grid.ac/institutes/grid.8065.b", 
          "name": [
            "Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Galappaththy", 
        "givenName": "Priyadarshani", 
        "id": "sg:person.01173533466.32", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01173533466.32"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka", 
          "id": "http://www.grid.ac/institutes/grid.8065.b", 
          "name": [
            "Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Constantine", 
        "givenName": "Godwin Roger", 
        "id": "sg:person.0610671515.19", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0610671515.19"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia", 
          "id": "http://www.grid.ac/institutes/grid.1024.7", 
          "name": [
            "Department of Physiology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka", 
            "Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Jayawardena", 
        "givenName": "Ranil", 
        "id": "sg:person.01026605536.26", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01026605536.26"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Industrial Technology Institute, Colombo, Sri Lanka", 
          "id": "http://www.grid.ac/institutes/grid.473355.3", 
          "name": [
            "Industrial Technology Institute, Colombo, Sri Lanka"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Weeratunga", 
        "givenName": "Hasitha Dhananjaya", 
        "id": "sg:person.07416332023.88", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.07416332023.88"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Industrial Technology Institute, Colombo, Sri Lanka", 
          "id": "http://www.grid.ac/institutes/grid.473355.3", 
          "name": [
            "Industrial Technology Institute, Colombo, Sri Lanka"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Premakumara", 
        "givenName": "Sirimal", 
        "id": "sg:person.01147075215.22", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01147075215.22"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka", 
          "id": "http://www.grid.ac/institutes/grid.8065.b", 
          "name": [
            "Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Katulanda", 
        "givenName": "Prasad", 
        "id": "sg:person.01221545265.99", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01221545265.99"
        ], 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "sg:pub.10.1007/s11886-014-0476-5", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1048710463", 
          "https://doi.org/10.1007/s11886-014-0476-5"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/s12992-014-0081-9", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1041305653", 
          "https://doi.org/10.1186/s12992-014-0081-9"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/s12906-017-2067-7", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1100090053", 
          "https://doi.org/10.1186/s12906-017-2067-7"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/1475-2891-11-63", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1012074228", 
          "https://doi.org/10.1186/1475-2891-11-63"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2017-09-29", 
    "datePublishedReg": "2017-09-29", 
    "description": "BackgroundPrevious studies have explored the anti-diabetic effects of Cinnamomum cassia extract in vivo and in vitro. However, there are no studies at present exploring the effects of the indigenous species of Sri Lankan cinnamon (Cinnamomum zeylanicum) in patients with diabetes mellitus. The present study aims to evaluate the potential effects of Cinnamomum zeylanicum extract as a pharmaceutical agent in patients with type-2 diabetes mellitus.Methods/designThe study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 4\u00a0months at the Medical Clinic, University Medical Unit, National Hospital of Sri Lanka. A total of 210 subjects with diabetes, in three equal groups, will be recruited for the study. The patients will be randomized in a 1:1:1 ratio according to the method of block randomization and the subjects will be randomly and equally assigned into two test groups (n\u2009=\u200970 each) and one placebo group (n\u2009=\u200970). The population will be stratified at randomization based on age, gender and disease severity. The treatment drug is a capsule containing Cinnamomum zeylanicum extract as the active ingredient and the placebo capsule will contain lactose monohydrate. Two doses of Cinnamomum zeylanicum extracts (250\u00a0mg and 500\u00a0mg of the cinnamon extract) will be used. The study drugs will be double blinded to both investigators and participants. The visits and the evaluations will be done as follows: screening (visit 0), 1\u00a0month (visit 1), 2\u00a0months (visit 2), 3\u00a0months (visit 3) and 4\u00a0months (visit 4). The following primary outcome measures will be evaluated: glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG) and serum insulin. Secondary outcome measures include: Body Mass Index (BMI) and other anthropometric parameters, blood pressure, total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL) and triglycerides (TAG). Data will be analyzed using SPSS version 14.DiscussionWe describe the protocol for a clinical trial design evaluating the effects of Cinnamomum zeylanicum (Ceylon cinnamon) in patients with type-2 diabetes mellitus. The result of the present study, positive or negative, should provide a step change in the evidence guiding current and future policies regarding the use of cinnamon dietary supplementation in patients with diabetes.Trial registrationSri Lanka Clinical Trials Registry (SLCTR), identifier: SLCTR/2017/010 (http://slctr.lk/trials/714). Registered on 5 April 2017; study protocol version 3.1 21 March 2017.", 
    "genre": "article", 
    "id": "sg:pub.10.1186/s13063-017-2192-0", 
    "isAccessibleForFree": true, 
    "isPartOf": [
      {
        "id": "sg:journal.1297400", 
        "issn": [
          "1468-6708", 
          "1745-6215"
        ], 
        "name": "Trials", 
        "publisher": "Springer Nature", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "1", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "18"
      }
    ], 
    "keywords": [
      "type 2 diabetes mellitus", 
      "low-density lipoprotein cholesterol", 
      "high-density lipoprotein cholesterol", 
      "Cinnamomum zeylanicum extracts", 
      "body mass index", 
      "diabetes mellitus", 
      "lipoprotein cholesterol", 
      "outcome measures", 
      "placebo-controlled clinical trial", 
      "Secondary outcome measures", 
      "Clinical Trials Registry", 
      "primary outcome measure", 
      "anti-diabetic effects", 
      "University Medical Unit", 
      "pharmaceutical agents", 
      "clinical trial design", 
      "placebo group", 
      "placebo capsules", 
      "study drug", 
      "serum insulin", 
      "blood pressure", 
      "total cholesterol", 
      "Trials Registry", 
      "mass index", 
      "present study", 
      "National Hospital", 
      "plasma glucose", 
      "BackgroundPrevious studies", 
      "study protocol", 
      "clinical trials", 
      "block randomization", 
      "treatment drugs", 
      "anthropometric parameters", 
      "dietary supplementation", 
      "designThe study", 
      "trial design", 
      "mellitus", 
      "patients", 
      "equal groups", 
      "Cinnamomum zeylanicum", 
      "medical units", 
      "disease severity", 
      "medical clinics", 
      "test group", 
      "months", 
      "cholesterol", 
      "potential pharmaceutical agents", 
      "Cinnamomum cassia", 
      "diabetes", 
      "Sri Lankan cinnamon", 
      "trials", 
      "drugs", 
      "randomization", 
      "group", 
      "capsule", 
      "subjects", 
      "active ingredients", 
      "potential effects", 
      "extract", 
      "registry", 
      "clinic", 
      "hospital", 
      "triglycerides", 
      "study", 
      "agents", 
      "insulin", 
      "doses", 
      "visits", 
      "zeylanicum", 
      "severity", 
      "supplementation", 
      "hemoglobin", 
      "age", 
      "effect", 
      "total", 
      "vivo", 
      "protocol", 
      "glucose", 
      "measures", 
      "participants", 
      "gender", 
      "investigators", 
      "cinnamon", 
      "population", 
      "Sri Lanka", 
      "evidence", 
      "index", 
      "future policy", 
      "period", 
      "cassia", 
      "evaluation", 
      "changes", 
      "pressure", 
      "use", 
      "data", 
      "units", 
      "ratio", 
      "ingredients", 
      "Lanka", 
      "results", 
      "identifiers", 
      "method", 
      "lactose monohydrate", 
      "parameters", 
      "monohydrate", 
      "design", 
      "species", 
      "policy", 
      "step change", 
      "indigenous species"
    ], 
    "name": "Cinnamomum zeylanicum (Ceylon cinnamon) as a potential pharmaceutical agent for type-2 diabetes mellitus: study protocol for a randomized controlled trial", 
    "pagination": "446", 
    "productId": [
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1091991393"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1186/s13063-017-2192-0"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "28962661"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1186/s13063-017-2192-0", 
      "https://app.dimensions.ai/details/publication/pub.1091991393"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2022-11-24T21:01", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-springernature-scigraph/baseset/20221124/entities/gbq_results/article/article_718.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "https://doi.org/10.1186/s13063-017-2192-0"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1186/s13063-017-2192-0'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1186/s13063-017-2192-0'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1186/s13063-017-2192-0'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1186/s13063-017-2192-0'


 

This table displays all metadata directly associated to this object as RDF triples.

330 TRIPLES      21 PREDICATES      162 URIs      150 LITERALS      30 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1186/s13063-017-2192-0 schema:about N17f1c950a18848eb850a343980020721
2 N2e9b94e94d8a4a1a9fa5296d6077c6b3
3 N314f20d02f29466cab7790ec7e20a14a
4 N3f6f5c04380c42c1b8baf812961ca574
5 N40e670515c8744169f2e7370f420e4fa
6 N57ae8dc118574e3490c89989cc910dc1
7 N5eb0cf7a033044bdb155b1c172f1c924
8 N67776bd989654f0aa0876e32c3a7e9b3
9 N682d45cc5d9e448a97fb019a24ba509e
10 N69166ac59ce34f468777dba37e9f1f60
11 N69e7fd55f82a41e2aa6098c80e53aee2
12 N78c44b7619ea479998fb1ef1464e4fca
13 N7bfc7e05d751428fa343e32ee9073bd2
14 N7c84d8edb678468081566a9fb73d3e53
15 N978ca0b18a434d4baf10507b486c2e86
16 N9a0fea92a74745b2980f4e2634342592
17 N9e21a6e366894abb9f12e97e9565fcc0
18 Nb95cf6acb0f446c0bd28ddd5ef5697c9
19 Nc021a9ee93e14409bf802ed1170c31d5
20 Nc8076cab72dd4f42bf03dffae55e8f72
21 Nd4a4602e86314d2ab1b0c9de53169463
22 Nd6f9d36f3dc648548872f0f6a157810e
23 Ne0156df44a364530a67dd38a55f7b14c
24 anzsrc-for:11
25 anzsrc-for:1103
26 schema:author N6cbbaa59c8d24fe0adadc48180f54f0a
27 schema:citation sg:pub.10.1007/s11886-014-0476-5
28 sg:pub.10.1186/1475-2891-11-63
29 sg:pub.10.1186/s12906-017-2067-7
30 sg:pub.10.1186/s12992-014-0081-9
31 schema:datePublished 2017-09-29
32 schema:datePublishedReg 2017-09-29
33 schema:description BackgroundPrevious studies have explored the anti-diabetic effects of Cinnamomum cassia extract in vivo and in vitro. However, there are no studies at present exploring the effects of the indigenous species of Sri Lankan cinnamon (Cinnamomum zeylanicum) in patients with diabetes mellitus. The present study aims to evaluate the potential effects of Cinnamomum zeylanicum extract as a pharmaceutical agent in patients with type-2 diabetes mellitus.Methods/designThe study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 4 months at the Medical Clinic, University Medical Unit, National Hospital of Sri Lanka. A total of 210 subjects with diabetes, in three equal groups, will be recruited for the study. The patients will be randomized in a 1:1:1 ratio according to the method of block randomization and the subjects will be randomly and equally assigned into two test groups (n = 70 each) and one placebo group (n = 70). The population will be stratified at randomization based on age, gender and disease severity. The treatment drug is a capsule containing Cinnamomum zeylanicum extract as the active ingredient and the placebo capsule will contain lactose monohydrate. Two doses of Cinnamomum zeylanicum extracts (250 mg and 500 mg of the cinnamon extract) will be used. The study drugs will be double blinded to both investigators and participants. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 2 months (visit 2), 3 months (visit 3) and 4 months (visit 4). The following primary outcome measures will be evaluated: glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG) and serum insulin. Secondary outcome measures include: Body Mass Index (BMI) and other anthropometric parameters, blood pressure, total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL) and triglycerides (TAG). Data will be analyzed using SPSS version 14.DiscussionWe describe the protocol for a clinical trial design evaluating the effects of Cinnamomum zeylanicum (Ceylon cinnamon) in patients with type-2 diabetes mellitus. The result of the present study, positive or negative, should provide a step change in the evidence guiding current and future policies regarding the use of cinnamon dietary supplementation in patients with diabetes.Trial registrationSri Lanka Clinical Trials Registry (SLCTR), identifier: SLCTR/2017/010 (http://slctr.lk/trials/714). Registered on 5 April 2017; study protocol version 3.1 21 March 2017.
34 schema:genre article
35 schema:isAccessibleForFree true
36 schema:isPartOf N1f35b88015cb4d8cb10a28ecdc046aff
37 Nab2234474de64199b5270c91e9a31434
38 sg:journal.1297400
39 schema:keywords BackgroundPrevious studies
40 Cinnamomum cassia
41 Cinnamomum zeylanicum
42 Cinnamomum zeylanicum extracts
43 Clinical Trials Registry
44 Lanka
45 National Hospital
46 Secondary outcome measures
47 Sri Lanka
48 Sri Lankan cinnamon
49 Trials Registry
50 University Medical Unit
51 active ingredients
52 age
53 agents
54 anthropometric parameters
55 anti-diabetic effects
56 block randomization
57 blood pressure
58 body mass index
59 capsule
60 cassia
61 changes
62 cholesterol
63 cinnamon
64 clinic
65 clinical trial design
66 clinical trials
67 data
68 design
69 designThe study
70 diabetes
71 diabetes mellitus
72 dietary supplementation
73 disease severity
74 doses
75 drugs
76 effect
77 equal groups
78 evaluation
79 evidence
80 extract
81 future policy
82 gender
83 glucose
84 group
85 hemoglobin
86 high-density lipoprotein cholesterol
87 hospital
88 identifiers
89 index
90 indigenous species
91 ingredients
92 insulin
93 investigators
94 lactose monohydrate
95 lipoprotein cholesterol
96 low-density lipoprotein cholesterol
97 mass index
98 measures
99 medical clinics
100 medical units
101 mellitus
102 method
103 monohydrate
104 months
105 outcome measures
106 parameters
107 participants
108 patients
109 period
110 pharmaceutical agents
111 placebo capsules
112 placebo group
113 placebo-controlled clinical trial
114 plasma glucose
115 policy
116 population
117 potential effects
118 potential pharmaceutical agents
119 present study
120 pressure
121 primary outcome measure
122 protocol
123 randomization
124 ratio
125 registry
126 results
127 serum insulin
128 severity
129 species
130 step change
131 study
132 study drug
133 study protocol
134 subjects
135 supplementation
136 test group
137 total
138 total cholesterol
139 treatment drugs
140 trial design
141 trials
142 triglycerides
143 type 2 diabetes mellitus
144 units
145 use
146 visits
147 vivo
148 zeylanicum
149 schema:name Cinnamomum zeylanicum (Ceylon cinnamon) as a potential pharmaceutical agent for type-2 diabetes mellitus: study protocol for a randomized controlled trial
150 schema:pagination 446
151 schema:productId N643f04d502d44c77b8b90b23d0c28281
152 Nc9d86f15d7074350a4fc701cde2d6e5a
153 Ne7144393e0d64ee38edf0eeb57f4b602
154 schema:sameAs https://app.dimensions.ai/details/publication/pub.1091991393
155 https://doi.org/10.1186/s13063-017-2192-0
156 schema:sdDatePublished 2022-11-24T21:01
157 schema:sdLicense https://scigraph.springernature.com/explorer/license/
158 schema:sdPublisher Nd74e846437be4b30b220441f1f599fca
159 schema:url https://doi.org/10.1186/s13063-017-2192-0
160 sgo:license sg:explorer/license/
161 sgo:sdDataset articles
162 rdf:type schema:ScholarlyArticle
163 N17f1c950a18848eb850a343980020721 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
164 schema:name Double-Blind Method
165 rdf:type schema:DefinedTerm
166 N1f35b88015cb4d8cb10a28ecdc046aff schema:issueNumber 1
167 rdf:type schema:PublicationIssue
168 N2e9b94e94d8a4a1a9fa5296d6077c6b3 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
169 schema:name Research Design
170 rdf:type schema:DefinedTerm
171 N314f20d02f29466cab7790ec7e20a14a schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
172 schema:name Blood Glucose
173 rdf:type schema:DefinedTerm
174 N3f6f5c04380c42c1b8baf812961ca574 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
175 schema:name Insulin
176 rdf:type schema:DefinedTerm
177 N40e670515c8744169f2e7370f420e4fa schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
178 schema:name Sri Lanka
179 rdf:type schema:DefinedTerm
180 N57ae8dc118574e3490c89989cc910dc1 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
181 schema:name Time Factors
182 rdf:type schema:DefinedTerm
183 N5eb0cf7a033044bdb155b1c172f1c924 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
184 schema:name Male
185 rdf:type schema:DefinedTerm
186 N643f04d502d44c77b8b90b23d0c28281 schema:name pubmed_id
187 schema:value 28962661
188 rdf:type schema:PropertyValue
189 N67776bd989654f0aa0876e32c3a7e9b3 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
190 schema:name Hypoglycemic Agents
191 rdf:type schema:DefinedTerm
192 N682d45cc5d9e448a97fb019a24ba509e schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
193 schema:name Adult
194 rdf:type schema:DefinedTerm
195 N69166ac59ce34f468777dba37e9f1f60 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
196 schema:name Humans
197 rdf:type schema:DefinedTerm
198 N69e7fd55f82a41e2aa6098c80e53aee2 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
199 schema:name Glycated Hemoglobin A
200 rdf:type schema:DefinedTerm
201 N6cbbaa59c8d24fe0adadc48180f54f0a rdf:first sg:person.0715170063.93
202 rdf:rest Nf4c532f1851b446f973134d6cc69a109
203 N78c44b7619ea479998fb1ef1464e4fca schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
204 schema:name Clinical Protocols
205 rdf:type schema:DefinedTerm
206 N7bfc7e05d751428fa343e32ee9073bd2 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
207 schema:name Cinnamomum zeylanicum
208 rdf:type schema:DefinedTerm
209 N7c84d8edb678468081566a9fb73d3e53 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
210 schema:name Adolescent
211 rdf:type schema:DefinedTerm
212 N8d9df780b9fe40c48ad4299990bb7a9b rdf:first sg:person.01026605536.26
213 rdf:rest Nc793483544e042139a226746b45c647f
214 N978ca0b18a434d4baf10507b486c2e86 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
215 schema:name Female
216 rdf:type schema:DefinedTerm
217 N9a0fea92a74745b2980f4e2634342592 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
218 schema:name Diabetes Mellitus, Type 2
219 rdf:type schema:DefinedTerm
220 N9e21a6e366894abb9f12e97e9565fcc0 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
221 schema:name Treatment Outcome
222 rdf:type schema:DefinedTerm
223 Nab2234474de64199b5270c91e9a31434 schema:volumeNumber 18
224 rdf:type schema:PublicationVolume
225 Nb95cf6acb0f446c0bd28ddd5ef5697c9 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
226 schema:name Biomarkers
227 rdf:type schema:DefinedTerm
228 Nbde15ad1851e475095d263d92bde6f94 rdf:first sg:person.0610671515.19
229 rdf:rest N8d9df780b9fe40c48ad4299990bb7a9b
230 Nc021a9ee93e14409bf802ed1170c31d5 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
231 schema:name Young Adult
232 rdf:type schema:DefinedTerm
233 Nc793483544e042139a226746b45c647f rdf:first sg:person.07416332023.88
234 rdf:rest Nd1980652bdff434ea445fdd3f5dee01e
235 Nc8076cab72dd4f42bf03dffae55e8f72 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
236 schema:name Middle Aged
237 rdf:type schema:DefinedTerm
238 Nc9d86f15d7074350a4fc701cde2d6e5a schema:name dimensions_id
239 schema:value pub.1091991393
240 rdf:type schema:PropertyValue
241 Nd1980652bdff434ea445fdd3f5dee01e rdf:first sg:person.01147075215.22
242 rdf:rest Nfb4e281db5cb4ffa9e8d948ee31368c4
243 Nd4a4602e86314d2ab1b0c9de53169463 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
244 schema:name Aged
245 rdf:type schema:DefinedTerm
246 Nd6f9d36f3dc648548872f0f6a157810e schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
247 schema:name Severity of Illness Index
248 rdf:type schema:DefinedTerm
249 Nd74e846437be4b30b220441f1f599fca schema:name Springer Nature - SN SciGraph project
250 rdf:type schema:Organization
251 Ne0156df44a364530a67dd38a55f7b14c schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
252 schema:name Plant Extracts
253 rdf:type schema:DefinedTerm
254 Ne7144393e0d64ee38edf0eeb57f4b602 schema:name doi
255 schema:value 10.1186/s13063-017-2192-0
256 rdf:type schema:PropertyValue
257 Nf4c532f1851b446f973134d6cc69a109 rdf:first sg:person.01173533466.32
258 rdf:rest Nbde15ad1851e475095d263d92bde6f94
259 Nfb4e281db5cb4ffa9e8d948ee31368c4 rdf:first sg:person.01221545265.99
260 rdf:rest rdf:nil
261 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
262 schema:name Medical and Health Sciences
263 rdf:type schema:DefinedTerm
264 anzsrc-for:1103 schema:inDefinedTermSet anzsrc-for:
265 schema:name Clinical Sciences
266 rdf:type schema:DefinedTerm
267 sg:journal.1297400 schema:issn 1468-6708
268 1745-6215
269 schema:name Trials
270 schema:publisher Springer Nature
271 rdf:type schema:Periodical
272 sg:person.01026605536.26 schema:affiliation grid-institutes:grid.1024.7
273 schema:familyName Jayawardena
274 schema:givenName Ranil
275 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01026605536.26
276 rdf:type schema:Person
277 sg:person.01147075215.22 schema:affiliation grid-institutes:grid.473355.3
278 schema:familyName Premakumara
279 schema:givenName Sirimal
280 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01147075215.22
281 rdf:type schema:Person
282 sg:person.01173533466.32 schema:affiliation grid-institutes:grid.8065.b
283 schema:familyName Galappaththy
284 schema:givenName Priyadarshani
285 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01173533466.32
286 rdf:type schema:Person
287 sg:person.01221545265.99 schema:affiliation grid-institutes:grid.8065.b
288 schema:familyName Katulanda
289 schema:givenName Prasad
290 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01221545265.99
291 rdf:type schema:Person
292 sg:person.0610671515.19 schema:affiliation grid-institutes:grid.8065.b
293 schema:familyName Constantine
294 schema:givenName Godwin Roger
295 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0610671515.19
296 rdf:type schema:Person
297 sg:person.0715170063.93 schema:affiliation grid-institutes:grid.8065.b
298 schema:familyName Ranasinghe
299 schema:givenName Priyanga
300 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0715170063.93
301 rdf:type schema:Person
302 sg:person.07416332023.88 schema:affiliation grid-institutes:grid.473355.3
303 schema:familyName Weeratunga
304 schema:givenName Hasitha Dhananjaya
305 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.07416332023.88
306 rdf:type schema:Person
307 sg:pub.10.1007/s11886-014-0476-5 schema:sameAs https://app.dimensions.ai/details/publication/pub.1048710463
308 https://doi.org/10.1007/s11886-014-0476-5
309 rdf:type schema:CreativeWork
310 sg:pub.10.1186/1475-2891-11-63 schema:sameAs https://app.dimensions.ai/details/publication/pub.1012074228
311 https://doi.org/10.1186/1475-2891-11-63
312 rdf:type schema:CreativeWork
313 sg:pub.10.1186/s12906-017-2067-7 schema:sameAs https://app.dimensions.ai/details/publication/pub.1100090053
314 https://doi.org/10.1186/s12906-017-2067-7
315 rdf:type schema:CreativeWork
316 sg:pub.10.1186/s12992-014-0081-9 schema:sameAs https://app.dimensions.ai/details/publication/pub.1041305653
317 https://doi.org/10.1186/s12992-014-0081-9
318 rdf:type schema:CreativeWork
319 grid-institutes:grid.1024.7 schema:alternateName Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia
320 schema:name Department of Physiology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka
321 Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia
322 rdf:type schema:Organization
323 grid-institutes:grid.473355.3 schema:alternateName Industrial Technology Institute, Colombo, Sri Lanka
324 schema:name Industrial Technology Institute, Colombo, Sri Lanka
325 rdf:type schema:Organization
326 grid-institutes:grid.8065.b schema:alternateName Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka
327 Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka
328 schema:name Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka
329 Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka
330 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...