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

Menstrual Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05312190
• Other study ID #: ZhenQi202201
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2022
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: June 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Menstrual Disorders
• Menstruation Disturbances

Intervention

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.
• 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

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (10)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual improvement	Menstrual improvement in cycle period	Within 3 months after the trial complete
Primary	Menstrual improvement	Menstrual improvement in menstrual volume	Within 3 months after the trial complete
Primary	Menstrual improvement	Menstrual improvement in number of days with bleeding or spotting	Within 3 months after the trial complete
Primary	Menstrual improvement	Menstrual improvement in monthly rates of amenorrhea	Within 3 months after the trial complete
Secondary	Sex hormone levels	mainly FSH, LH,E2 and AMH	Within 3 months after the trial complete
Secondary	AFC	Changes in AFC in pelvic ultrasonography	Within 3 months after the trial complete
Secondary	SF-36	The change of the MOS item short from health survey	Within 3 months after the trial complete