Traditional Chinese medicine (Liang-Xue-Di-Huang Decoction) for hemorrhoid hemorrhage: Study Protocol Clinical Trial (SPIRIT Compliant).

Abstract:

BACKGROUND:Hemorrhoidal disease (HD) is one of the commonest proctologic condition in the general population. Medical therapy for HD has not been formally confirmed due to the inconsistent of results. Liang-Xue-Di-Huang Decoction, a kind of ancient Chinese classical prescription, has been used to treat HD from the 19th century in China. However, clinical research of Liang-Xue-Di-Huang Decoction in the treatment of HD was lack. We designed this study to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in the treatment of HD. METHODS/DESIGN:A randomized, controlled, double blind, double-mimetic agent, and multicenter trial to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction is proposed. HD patients (stage I, II, III) will be randomly assigned into experimental group or control group. HD patients will receive a 7-day treatments and a 7-day follow-up. The primary outcome measure is the Hemorrhoid Bleeding Score in 7 and 14 days. The Secondary outcome measures are Goligher prolapse score and quality-of-life score in 7 and 14 days. DISCUSSION:This study will provide objective evidences to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in treatment of HD.

journal_name

Medicine (Baltimore)

journal_title

Medicine

authors

Shi SY,Zhou Q,He ZQ,Shen ZF,Zhang WX,Zhang D,Xu CB,Geng J,Wu BS,Chen YG

doi

10.1097/MD.0000000000019720

subject

Has Abstract

pub_date

2020-04-01 00:00:00

pages

e19720

issue

16

eissn

0025-7974

issn

1536-5964

pii

00005792-202004170-00044

journal_volume

99

pub_type

杂志文章,多中心研究,随机对照试验

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