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

Shi, Shuo-Yang / Zhou, Qing / He, Zong-Qi / Shen, Zhao-Feng / Zhang, Wei-Xin / Zhang, Dan / Xu, Cheng-Biao / Geng, Ji / Wu, Ben-Sheng / Chen, Yu-Gen

Medicine

2020  Volume 99, Issue 16, Page(s) e19720

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 ... ...

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.
MeSH term(s) Humans ; Drugs, Chinese Herbal/therapeutic use ; Hemorrhage/drug therapy ; Hemorrhage/etiology ; Hemorrhoids/complications ; Hemorrhoids/drug therapy ; Medicine, Chinese Traditional ; Phytotherapy ; Multicenter Studies as Topic ; Randomized Controlled Trials as Topic
Chemical Substances Drugs, Chinese Herbal
Language English
Publishing date 2020-04-17
Publishing country United States
Document type Clinical Trial Protocol ; Journal Article
ZDB-ID 80184-7
ISSN 1536-5964 ; 0025-7974
ISSN (online) 1536-5964
ISSN 0025-7974
DOI 10.1097/MD.0000000000019720
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