Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Mar 21;18(1):135.
doi: 10.1186/s13063-017-1877-8.

Effect of Guizhifulingwan (Keishibukuryogan) on climacteric syndrome: study protocol for a randomized controlled pilot trial

Jung-Eun Kim  1 , Junghyo Cho  2 , Ojin Kwon  1 , Ae-Ran Kim  1 , Hyo-Ju Park  1 , So-Young Jung  1 , Joo-Hee Kim  1 , Mikyung Kim  1 , Hye-Yoon Lee  1 , Jun-Hwan Lee  3   4
Affiliations
Randomized Controlled Trial

Effect of Guizhifulingwan (Keishibukuryogan) on climacteric syndrome: study protocol for a randomized controlled pilot trial

Jung-Eun Kim et al. Trials. .

Abstract

Background: The aim of this study is to explore the efficacy of Guizhifulingwan (GFW) in the treatment of climacteric syndrome in women.

Methods/design: 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.

Discussion: 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.

Trial registration: Clinical Research Information Service (CRIS), Republic of Korea, KCT0002040 . Registered on 5 September 2016.

Keywords: Climacteric syndrome; Guizhifulingwan; Keishibukuryogan; Menopause; Randomized controlled trial.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Study flow chart
Fig. 2
Fig. 2
SPIRIT schedule for enrollment, interventions, and assessments
See this image and copyright information in PMC

References

    1. Poomalar GK, Arounassalame B. The quality of life during and after menopause among rural women. J Clin Diagn Res. 2013;7:135–9. doi: 10.1111/j.1752-699X.2012.00294.x. - DOI - PMC - PubMed
    1. North American Menopause Society The 2012 hormone therapy position statement of the North American Menopause Society. Menopause. 2012;19:257–71. doi: 10.1097/gme.0b013e31824b970a. - DOI - PMC - PubMed
    1. Boardman HM, Hartley L, Eisinga A, Main C, Roqué i Figuls M, Bonfill Cosp X, et al. Hormone therapy for preventing cardiovascular disease in post-menopausal women. Cochrane Database Syst Rev. 2015:CD002229; doi: 10.1002/14651858.CD002229.pub4. - PMC - PubMed
    1. Collaborative Group on Epidemiological Studies Of Ovarian Cancer. Beral V, Gaitskell K, Hermon C, Moser K, Reeves G, et al. Menopausal hormone use and ovarian cancer risk: individual participant meta-analysis of 52 epidemiological studies. Lancet. 2015;385:1835–42. doi: 10.1016/S0140-6736(14)61687-1. - DOI - PMC - PubMed
    1. Posadzki P, Lee MS, Moon TW, Choi TY, Park TY, Ernst E. Prevalence of complementary and alternative medicine (CAM) use by menopausal women: a systematic review of surveys. Maturitas. 2013;75:34–43. doi: 10.1016/j.maturitas.2013.02.005. - DOI - PubMed

Publication types

Associated data