Clinical trial NCT04942015: Honghuaruyi Wan for Endometriosis Dysmenorrhea
Official title: Beijing University of Chinese Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Endometriosis
Dysmenorrhea
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Endometriosis (EM) is a common gynecological disease at present. It is a gynecological disease caused by the growth and reproduction of the endometrium on the surface of tissues and organs beyond the uterine covering surface, resulting in recurrent abdominal pain and infertility. The pathogenesis of endometriosis may be related to female endocrine dysfunction and abnormal levels of estrogen and progesterone in the body. Its clinical symptoms mainly include dysmenorrhea, chronic pelvic pain and sexual pain.

The recurrence of endometriosis and the side effects of medication have troubled clinicians and patients for a long time. The search for new drugs has been going on.

Honghuaruyi Wan is a traditional Tibetan prescription, which is made by addition and subtraction on the basis of the traditional and classic Tibetan medicine prescription "25 Wei Guijiu Wan". Its main ingredients are: Honghua,Xihonghua,Taoerqi,Kezi,Zangqiancao,Rougui,Baxiaga,Zangmuxiang,Yuansuiguo,Jiangxiang,Xiongdanfen,Zangzicao,Guangmingyan,Ximalayazimoli,Bangga,Hujiao,Huasherou,Aizijin,Yuganzi,Shajigao,Naosha,Zicaorong,Gouqizi,Chenxiang,Huoxiao. It has the effects of dispelling wind-evil and relieving pain, regulating menstrual blood and removing spots. It can be used for vaginitis, cervical erosion, irregular menstruation, dysmenorrhea and other common gynecological diseases. The main medicinal ingredients of Honghuaruyi Wan are Honghua ,Taoerqi and Zanghonghua, which have the effects of relieving pain, regulating menstruation and blood and dispersing knots. Some clinical studies have shown that the basic prescription of Honghuaruyi Wan have a significant effect on the improvement of dysmenorrhea, which can significantly reduce the incidence of dysmenorrhea caused by oxytocin in mice, and improve the number of body twisting in dysmenorrhea model mice. Other clinical studies have shown that Honghuaruyi Wan can improve estradiol and prolactin levels of pituitary gland in rats with estrogen and progesterone, as well as reduce TNF-α levels, thus improving endometriosis dysmenorrhea.

For women of childbearing age who do not have fertility requirements, pain is the most important clinical symptom that needs to be addressed, especially with progressive dysmenorrhea. Therefore, in this study, the therapeutic effects of Honghuaruyi Wan, provided by Tibet Qizheng Tibetan Medicine Co.,Ltd, on the secondary dysmenorrhea of 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.

Eligibility 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.

Primary outcomes:
measure: Visual Analogue Scale/Score (VAS)
timeFrame: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
measure: Endometriosis Health Profle-5（EHP-5）
timeFrame: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
measure: The 5-level EQ-5D version（EQ-5D-5L）
timeFrame: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
Secondary outcomes:
measure: Visual Analogue Scale/Score (VAS) of the maximum non-menstrual pelvic pain
timeFrame: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
measure: The number of ibuprofen sustained-release capsules (or other NSAIDs) used
timeFrame: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
measure: Number of days off for staff/students due to dysmenorrhea
timeFrame: Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)
measure: The maximum diameter of the uterus
timeFrame: Baseline, After treatment (3rd menstrual cycle). (One cycle = 28±7days)
measure: The maximum diameter of the cysts
timeFrame: Baseline, After treatment (3rd menstrual cycle). (One cycle = 28±7days)
Other outcomes:
Locations:
Study officials:
affiliation: Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicne
name: Mei Han
role: STUDY_CHAIR
References: