Clinical trial NCT05312190: Clinical and Basic Researches Related to ZhenQi Buxue Oral Liquid in Treating Menstrual Disorders
Official title: Clinical and Basic Researches Related to ZhenQi Buxue Oral Liquid in Treating Menstrual Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Menstrual Disorders
Keywords: Menstrual disorders
Traditional Chinese medicine
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: West China Second University Hospital
name: Chongqing Medical University No.1 Affiliated Hospital
name: The Second Hospital of Hebei Medical University
name: Second Affiliated Hospital of Nanchang University
name: Zhongda Hospital
name: Hubei Maternal and Child Health Hospital
name: Liuzhou Maternity and Child Healthcare Hospital
name: Zhejiang University Medical College Affiliated Hangzhou First People's Hospital
name: Guangzhou Women and Children's Medical Center
First posted: 2022-04-05
Enrollment: 330
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a national multicenter prospective, randomized, controlled trial. 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.
Primary purpose: TREATMENT

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 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.

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 more importantly oligomenorrhea, amenorrhea, and decreased menstrual flow.At present, the main method of western medicine for the treatment of menstrual disorders is hormone replacement therapy, but the incidence of adverse reactions is high, and the clinical effect is mediocre. Traditional Chinese medicine in my country mostly adopts holistic conditioning therapy for the treatment of irregular menstruation.

Zhenqi Buxue Oral Liquid consists of sheep placenta, pearl, red ginseng, wolfberry, astragalus, angelica, coix seed, ginger and jujube. The excipients are protein sugar and sodium benzoate. Nourishes qi and blood. It is suitable for dizziness, pale complexion, fatigue, lack of energy and lazy words caused by insufficient qi and blood.

This study will conduct a comprehensive and in-depth study on its treatment of mental and psychological stress and menstrual disorders with "oligomenorrhea, amenorrhea, amenorrhea and decreased menstrual flow" as the main manifestations. The molecular mechanism and clinical improvement, and the safety and adverse reactions of its use paln to be clarified.

Eligibility 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.

Primary outcomes:
measure: Menstrual improvement
timeFrame: Within 3 months after the trial complete
measure: Menstrual improvement
timeFrame: Within 3 months after the trial complete
measure: Menstrual improvement
timeFrame: Within 3 months after the trial complete
measure: Menstrual improvement
timeFrame: Within 3 months after the trial complete
Secondary outcomes:
measure: Sex hormone levels
timeFrame: Within 3 months after the trial complete
measure: AFC
timeFrame: Within 3 months after the trial complete
measure: SF-36
timeFrame: Within 3 months after the trial complete
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: