Danggwijagyaksan for climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern: study protocol for a randomized, double-blind, ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-01-15

AUTHORS

Mikyung Kim, Ae-Ran Kim, Hyo-Ju Park, Ojin Kwon, Joo-Hee Kim, Eun-Ji Park, Seon-Eun Baek, Jeong-Eun Yoo, Jun-Hwan Lee

ABSTRACT

BACKGROUND: This study aims to explore the safety, efficacy, and feasibility of Danggwijagyaksan (DJS) for alleviating climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern. METHODS/DESIGN: This is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 34 women with climacteric syndrome who have signed informed consent forms will be registered in this study. Placebo or DJS will be randomly assigned to the participants in an equal proportion. The participants will visit the clinical trial center every 2 weeks and receive placebo or DJS granules. The treatment period is 4 weeks and the administration frequency is three times daily. Data will be collected from the participants at baseline, at week 5, and at week 9 after random allocation. The primary outcome measure will be the mean change in the Menopause Rating Scale from baseline to week 5. Secondary outcome measures will include the World Health Organization Quality of Life-BREF (WHOQOL-BREF) score, the Blood Deficiency Scoring System score, lean body mass, and blood tests, including serum follicle-stimulating hormone and estradiol concentration. To assess the safety of DJS, a laboratory test will be conducted before and after treatment and the participants will be asked about any occurrence of adverse events every visit. The recruitment rate, completion rate, and medication adherence will also be calculated, to assess feasibility. DISCUSSION: The findings of this study will provide the basis for a full-scale randomized controlled trial to confirm the safety and efficacy of DJS for the treatment of climacteric syndrome in peri- and postmenopausal women. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), Republic of Korea, KCT0002387 . Registered on 25 July 2017. More... »

PAGES

41

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s13063-018-2443-8

DOI

http://dx.doi.org/10.1186/s13063-018-2443-8

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1100403222

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29335018


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43 Life-BREF (WHOQOL-BREF) score
44 Menopause Rating Scale
45 Organization Quality
46 Rating Scale
47 Republic
48 Republic of Korea
49 Research Information Service
50 Scoring System score
51 Secondary outcome measures
52 System score
53 World Health Organization Quality
54 adherence
55 administration frequency
56 adverse events
57 allocation
58 baseline
59 basis
60 blood tests
61 blood-deficiency dominant pattern
62 body mass
63 center
64 changes
65 climacteric syndrome
66 clinical trials
67 completion rates
68 concentration
69 consent form
70 data
71 dominant pattern
72 efficacy
73 efficacy of DJS
74 equal proportions
75 estradiol concentrations
76 events
77 feasibility
78 feasibility of Danggwijagyaksan
79 findings
80 follicle-stimulating hormone
81 form
82 frequency
83 granules
84 hormone
85 information services
86 informed consent form
87 laboratory tests
88 lean body mass
89 mass
90 mean change
91 measures
92 medication adherence
93 occurrence
94 outcome measures
95 participants
96 patterns
97 period
98 pilot clinical trial
99 pilot trial
100 placebo
101 placebo-controlled pilot clinical trial
102 placebo-controlled pilot trial
103 postmenopausal women
104 primary outcome measure
105 proportion
106 protocol
107 quality
108 random allocation
109 rate
110 recruitment rates
111 safety
112 safety of DJS
113 scale
114 scores
115 serum follicle-stimulating hormone
116 services
117 study
118 study protocol
119 syndrome
120 test
121 time
122 total
123 treatment
124 treatment period
125 trial centers
126 trials
127 visits
128 week 5
129 week 9
130 weeks
131 women
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