Effect of Guizhifulingwan (Keishibukuryogan) on climacteric syndrome: study protocol for a randomized controlled pilot trial.
The aim of this study is to explore the efficacy of Guizhifulingwan (GFW) in the treatment of climacteric syndrome in women.



This is a single-center, randomized, placebo-controlled, parallel-group design pilot trial. Fifty participants with climacteric syndrome will be randomly allocated to the GFW or placebo group in a 1:1 ratio. The participants will be administered GFW or placebo granules three times a day for 4 weeks and will be followed up for a further 4 weeks. The primary outcome is the mean change in menopause rating scale score at 5 weeks after randomization. Secondary outcomes include the World Health Organization quality of life-BREF scores, degrees of upward movement of qi and lower abdominal resistance and tenderness, blood stasis pattern questionnaire scores, and results of blood tests including assays for lipid profile, high sensitivity C-reactive protein, follicle-stimulating hormone, and estradiol. The feasibility outcomes include recruitment and completion rates and adherence to medication.



The results of this study will provide basic data for the design of a large-scale clinical trial for evaluating the efficacy of GFW in the treatment of climacteric syndrome in women.



Clinical Research Information Service (CRIS), Republic of Korea, KCT0002040 . Registered on 5 September 2016.
Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 34054, Republic of Korea.
Jung-Eun
JE
Kim
Department of Internal Korean Medicine, Daejeon Oriental Hospital of Daejeon University, 176-9, Daeheung-ro, Jung-gu, Daejeon, 34929, Republic of Korea.
Junghyo
J
Cho
Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 34054, Republic of Korea.
Ojin
O
Kwon
Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 34054, Republic of Korea.
Ae-Ran
AR
Kim
Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 34054, Republic of Korea.
Hyo-Ju
HJ
Park
Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 34054, Republic of Korea.
So-Young
SY
Jung
Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 34054, Republic of Korea.
Joo-Hee
JH
Kim
Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 34054, Republic of Korea.
Mikyung
M
Kim
Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 34054, Republic of Korea.
Hye-Yoon
HY
Lee
Clinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 34054, Republic of Korea. omdjun@kiom.re.kr.|University of Science & Technology (UST), Korean Medicine Life Science, Daejeon, 34054, Republic of Korea. omdjun@kiom.re.kr.
Jun-Hwan
0000-0001-5730-6869
JH
Lee
D015415:Biomarkers / Q000097:blood; D002985:Clinical Protocols; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008593:Menopause / Q000097:blood / Q000187:drug effects*; D008875:Middle Aged; D010865:Pilot Projects; D056910:Republic of Korea; D012107:Research Design; D013577:Syndrome; D013997:Time Factors; D016896:Treatment Outcome
D015415:Biomarkers; D004365:Drugs, Chinese Herbal; C054593:keishibukuryogan
Climacteric syndrome; Guizhifulingwan; Keishibukuryogan; Menopause; Randomized controlled trial