drugset / Trial / NCT04942015

Honghuaruyi Wan for Endometriosis Dysmenorrhea

NCT04942015 ↗

Phase 4 Unknown 164 enrolled Beijing University of Chinese Medicine
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Endometriosis is a common gynecological disease. It is a gynecological disease caused by the growth and reproduction of the endometrium beyond the surface of the uterine tissue and organs, which causes recurrent abdominal pain, infertility and other main symptoms. The recurrence of endometriosis and the side effects of medication have troubled clinicians and patients for a long time and the search for new drugs is going on all the time. Honghuaruyi Wan is the traditional Tibetan prescription, clinical research has proved that Honghuaruyi Wan can significantly reduce risk mouse dysmenorrhea caused by oxytocin, improve dysmenorrhea model of mice body torsion times and improve the estrogen and progestogen operator Netherlands rat pituitary estradiol and prolactin level, at the same time also can reduce the amount of TNF alpha, thus improving endometriosis dysmenorrhea. In this study, the therapeutic effects of Honghuaruyi Wan provided by Tibet Qizheng Tibetan Medicine Co.,Ltd on secondary dysmenorrhea in patients with endometriosis was evaluated clinically. A multi-center, randomized, double-blind, placebo-controlled clinical trial was designed to provide evidence-based medical evidence for Honghuaruyi Wan in the treatment of endometriosis dysmenorrhea. In the design of this trial, the therapeutic effects and safety of Honghuaruyi Wan in the treatment of dysmenorrhea secondary to endometriosis were evaluated with Honghuaruyi Wan in the treatment group and placebo in the control group.

Timeline

Start
2021-06-21
Primary completion
2022-05-31
Completion
2023-12-31

Outcome

Met primary endpoint

paper were significantly lower in the HHRY group compared to the placebo group at the final follow-up (3.00 vs 5.50, P < 0.001 PMID 41529972 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Honghuaruyi Wan Traditional medicine (herbal / TCM) 1 g Oral
Subject Honghuaruyi Wan Traditional medicine (herbal / TCM) 2 g Oral