Honghuaruyi Wan for Endometriosis Dysmenorrhea

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing University of Chinese Medicine

Criteria

Inclusion Criteria:

1. Meet the diagnostic criteria for endometriosis and have dysmenorrhea VAS score ≥4 points;

2. Age 18 to 45;

3. Regular menstrual cycle (28±7 days);

4. Not pregnant at the time of seeing a doctor and no pregnancy plan during the medication, can insist on contraception;

5. No pelvic nodules or adnexal masses, or pelvic nodules or adnexal masses ≤4cm;

6. CA125 is normal or slightly elevated (below 200U/ml).

7. Patients who voluntarily signed the informed consent and had conditional follow-up.

Exclusion Criteria:

1. Patients who have known to have malignancies of reproductive organs or other malignancies;

2. Suffering from serious diseases or mental diseases such as cardiovascular, cerebrovascular, liver, kidney or hematopoietic system;

3. Uterine fibroids (≥3cm) and adenomyosis (uterine over 6 weeks of gestation, the reference value of uterine tridiameter at 6 weeks is 12cm, 7.5cm, 4.5cm);

4. Those who received hormone drug therapy within 3 months before enrollment;

5. lactating patients.