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

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.

Study Overview

• Status: Recruiting
• Conditions: Menstrual Disorders
• Intervention / Treatment: Drug: ZhenQi BuXue KouFuYe; Drug: Progesterone Capsules

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.

• Study Type: Interventional
• Enrollment (Anticipated): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 1000730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Aijun Sun; Phone Number: 01018600045466
    • Beijing, Beijing, China, 10000
      • Recruiting
      • Lei Li
      • Contact: Lei L Li, MD; Phone Number: +86 13911988831; Email: lileigh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zhenqi Buxue Oral Liquid; Zhenqi Buxue Oral Liquid, 10 ml each time, 2 times a day for 3 menstrual cycles, orally	Drug: ZhenQi BuXue KouFuYe; 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.
Experimental: Zhenqi Buxue Oral Liquid and Progesterone Capsules; Zhenqi Buxue Oral Liquid was taken orally, 10 ml at a time, twice a day for 3 menstrual cycles + orally from the second half of menstrual cycle, Progesterone Capsules 200mg, once a day for 10 days for 3 menstrual cycles	Drug: ZhenQi BuXue KouFuYe; 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.; Drug: Progesterone Capsules; The main ingredient of Progesterone Capsules is abbsolutely progesterone,a kind of hormone,which is the main method of western medicine for the treatment of menstrual disorders
Active Comparator: Progesterone Capsules; Progesterone Capsules 200mg, qd*10 days*3 menstrual cycles, orally	Drug: Progesterone Capsules; The main ingredient of Progesterone Capsules is abbsolutely progesterone,a kind of hormone,which is the main method of western medicine for the treatment of menstrual disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual improvement	Menstrual improvement in cycle period	Within 3 months after the trial complete
Menstrual improvement	Menstrual improvement in menstrual volume	Within 3 months after the trial complete
Menstrual improvement	Menstrual improvement in number of days with bleeding or spotting	Within 3 months after the trial complete
Menstrual improvement	Menstrual improvement in monthly rates of amenorrhea	Within 3 months after the trial complete

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex hormone levels	mainly FSH, LH，E2 and AMH	Within 3 months after the trial complete
AFC	Changes in AFC in pelvic ultrasonography	Within 3 months after the trial complete
SF-36	The change of the MOS item short from health survey	Within 3 months after the trial complete

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Traditional Chinese medicine; Menstrual disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Disease; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: ZhenQi202201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No