Clinical and Basic Researches Related to ZhenQi Buxue Oral Liquid in Treating Menstrual Disorders

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

This study is a national multicenter prospective, randomized, controlled trial, which evaluates Zhenqi Buxue Oral Liquid，Progesterone Capsules and the addition of Zhenqi Buxue Oral Liquid to Progesterone Capsules in the treatment of menstrual disorders in adults women. One third of participanta will receive Zhenqi Buxue Oral Liquid, one third of participanta will receive Progesterone Capsules, and the another third will receive Zhenqi Buxue Oral Liquid and Progesterone Capsules in combination.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Chongqing Medical University No.1 Affiliated Hospital; Guangzhou Women and Children's Medical Center; Hubei Maternal and Child Health Hospital; Liuzhou Maternity and Child Healthcare Hospital; Second Affiliated Hospital of Nanchang University; Sichuan University West China Second University Hospital; Southeast University Affiliated Zhongda Hospital; The Second Hospital of Hebei Medical University; Zhejiang University Medical College Affiliated Hangzhou First People's Hospital
• Treatments: Progesterone

Criteria

Inclusion Criteria:

1. Aged between 25 and 40 years old;

2. Patients with oligomenorrhea or oligomenorrhea or menopause within three months (see Appendix 1: Diagnostic Criteria of Traditional Chinese and Western Medicine)

3. Meet the clinical medication conditions for progesterone to regulate menstruation

4. The research subjects were informed and voluntarily participated in this study, and signed the informed consent at the same time.

Exclusion Criteria:

1. Age <25 years or >40 years old, pregnant or breastfeeding women

2. Ovarian dysfunction caused by local ovarian surgery, radiotherapy and chemotherapy for previous malignant tumors, taking hormones or immunosuppressive drugs;

3. Combined with serious or unstable physical diseases that may affect the efficacy of drugs and the conduct of trials, including liver, kidney, gastrointestinal, cardiovascular, respiratory, endocrine, neurological, immune or blood system diseases, etc., mental patients .

4. Those who were allergic to the drugs used in the trial or had serious adverse reactions in the past;

5. Breast cancer or family history of breast cancer in first-degree relatives, irregular vaginal bleeding, uterine fibroids (≥3cm), endometriosis, atypical endometrial hyperplasia, endometrial cancer and other hormone-dependent reproduction Systemic diseases and other malignant tumors;

6. Those with a history of thromboembolic disease or thrombosis;

7. Participated in a clinical trial of another research drug within 3 months prior to inclusion in this study (the first interview);

8. Those who have used related drugs in the past 3 months or have abused or depended on substances (alcohol or drugs) in the past 3 months; heavy smokers (smokers who smoke 20 or more cigarettes per day);

9. Those who met the inclusion criteria, did not follow the doctor's advice, were unable to judge the curative effect or were unable to evaluate the curative effect due to incomplete data.