Article ; Online: Traditional Chinese medicine (Liang-Xue-Di-Huang Decoction) for hemorrhoid hemorrhage: Study Protocol Clinical Trial (SPIRIT Compliant).
2020 Volume 99, Issue 16, Page(s) e19720
Abstract: ... in the general population. Medical therapy for HD has not been formally confirmed due to the inconsistent of results. Liang ... 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 ...
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. |
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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 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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