Status:
UNKNOWN
Clinical and Basic Researches Related to ZhenQi Buxue Oral Liquid in Treating Menstrual Disorders
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
West China Second University Hospital
Chongqing Medical University No.1 Affiliated Hospital
Conditions:
Menstrual Disorders
Eligibility:
FEMALE
25-40 years
Phase:
NA
Brief 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 Progester...
Detailed Description
Menstrual disorders are one of the most common clinical symptoms in women. Since puberty, about 70% of women have experienced menstrual disorders, including early, delayed, shortened, prolonged, and m...
Eligibility Criteria
Inclusion
- Aged between 25 and 40 years old;
- Patients with oligomenorrhea or oligomenorrhea or menopause within three months (see Appendix 1: Diagnostic Criteria of Traditional Chinese and Western Medicine)
- Meet the clinical medication conditions for progesterone to regulate menstruation
- The research subjects were informed and voluntarily participated in this study, and signed the informed consent at the same time.
Exclusion
- Age \<25 years or \>40 years old, pregnant or breastfeeding women
- Ovarian dysfunction caused by local ovarian surgery, radiotherapy and chemotherapy for previous malignant tumors, taking hormones or immunosuppressive drugs;
- 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 .
- Those who were allergic to the drugs used in the trial or had serious adverse reactions in the past;
- 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;
- Those with a history of thromboembolic disease or thrombosis;
- Participated in a clinical trial of another research drug within 3 months prior to inclusion in this study (the first interview);
- 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);
- 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.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT05312190
Start Date
March 15 2022
End Date
June 30 2023
Last Update
April 5 2022
Active Locations (2)
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1
Lei Li
Beijing, Beijing Municipality, China, 10000
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 1000730