Effect of Guizhifulingwan Keishibukuryogan on climacteric syndrome: study protocol for a randomized controlled pilot trialReportar como inadecuado




Effect of Guizhifulingwan Keishibukuryogan on climacteric syndrome: study protocol for a randomized controlled pilot trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 18:135

First Online: 21 March 2017Received: 07 November 2016Accepted: 03 March 2017DOI: 10.1186-s13063-017-1877-8

Cite this article as: Kim, JE., Cho, J., Kwon, O. et al. Trials 2017 18: 135. doi:10.1186-s13063-017-1877-8

Abstract

BackgroundThe aim of this study is to explore the efficacy of Guizhifulingwan GFW in the treatment of climacteric syndrome in women.

Methods-designThis 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.

DiscussionThe 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 registrationClinical Research Information Service CRIS, Republic of Korea, KCT0002040. Registered on 5 September 2016.

KeywordsGuizhifulingwan Keishibukuryogan Climacteric syndrome Menopause Randomized controlled trial AbbreviationsAEAdverse event

ALPAlkaline phosphatase

ALTAlanine aminotransferase

ANCOVAAnalysis of covariance

ASTAspartate aminotransferase

BUNBlood urea nitrogen

CrCreatinine

E2Estradiol

EDCElectronic data capture

FASFull analysis set

FSHFollicle-stimulating hormone

GFWGuizhifulingwan

GMPGood manufacturing practice

GTPGlutamyl transpeptidase

HbHemoglobin

HctHematocrit

HRTHormone replacement therapy

Hs-CRPHigh sensitivity C-reactive protein

ITTIntention-to-treat

MRSMenopause rating scale

PPSPer-protocol set

RBCRed blood cell

RCTRandomized controlled trial

SASStrategic Applications Software

SPIRITStandard Protocol Items: Recommendations for Interventional Trials

TCMTraditional Chinese medicine

TKMTraditional Korean medicine

WBCWhite blood cell

WHOQOLWorld Health Organization quality of life

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-017-1877-8 contains supplementary material, which is available to authorized users.





Autor: Jung-Eun Kim - Junghyo Cho - Ojin Kwon - Ae-Ran Kim - Hyo-Ju Park - So-Young Jung - Joo-Hee Kim - Mikyung Kim - Hye-Yoon 

Fuente: https://link.springer.com/







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