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

Primary Purpose

Menstrual Disorders

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ZhenQi BuXue KouFuYe
Progesterone Capsules
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menstrual Disorders focused on measuring Menstrual disorders, Traditional Chinese medicine

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Lei LiRecruiting
  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Zhenqi Buxue Oral Liquid

Zhenqi Buxue Oral Liquid and Progesterone Capsules

Progesterone Capsules

Arm Description

Zhenqi Buxue Oral Liquid, 10 ml each time, 2 times a day for 3 menstrual cycles, orally

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

Progesterone Capsules 200mg, qd*10 days*3 menstrual cycles, orally

Outcomes

Primary Outcome Measures

Menstrual improvement
Menstrual improvement in cycle period
Menstrual improvement
Menstrual improvement in menstrual volume
Menstrual improvement
Menstrual improvement in number of days with bleeding or spotting
Menstrual improvement
Menstrual improvement in monthly rates of amenorrhea

Secondary Outcome Measures

Sex hormone levels
mainly FSH, LH，E2 and AMH
AFC
Changes in AFC in pelvic ultrasonography
SF-36
The change of the MOS item short from health survey

Full Information

First Posted
March 8, 2022
Last Updated
March 31, 2022
Sponsor
Peking Union Medical College Hospital
Collaborators
West China Second University Hospital, Chongqing Medical University No.1 Affiliated Hospital, The Second Hospital of Hebei Medical University, Second Affiliated Hospital of Nanchang University, Zhongda Hospital, Hubei Maternal and Child Health Hospital, Liuzhou Maternity and Child Healthcare Hospital, Zhejiang University Medical College Affiliated Hangzhou First People's Hospital, Guangzhou Women and Children's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05312190
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
West China Second University Hospital, Chongqing Medical University No.1 Affiliated Hospital, The Second Hospital of Hebei Medical University, Second Affiliated Hospital of Nanchang University, Zhongda Hospital, Hubei Maternal and Child Health Hospital, Liuzhou Maternity and Child Healthcare Hospital, Zhejiang University Medical College Affiliated Hangzhou First People's Hospital, Guangzhou Women and Children's Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Disorders
Keywords
Menstrual disorders, Traditional Chinese medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zhenqi Buxue Oral Liquid
Arm Type
Experimental
Arm Description
Zhenqi Buxue Oral Liquid, 10 ml each time, 2 times a day for 3 menstrual cycles, orally
Arm Title
Zhenqi Buxue Oral Liquid and Progesterone Capsules
Arm Type
Experimental
Arm Description
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
Arm Title
Progesterone Capsules
Arm Type
Active Comparator
Arm Description
Progesterone Capsules 200mg, qd*10 days*3 menstrual cycles, orally
Intervention Type
Drug
Intervention Name(s)
ZhenQi BuXue KouFuYe
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Progesterone Capsules
Intervention Description
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
Primary Outcome Measure Information:
Title
Menstrual improvement
Description
Menstrual improvement in cycle period
Time Frame
Within 3 months after the trial complete
Title
Menstrual improvement
Description
Menstrual improvement in menstrual volume
Time Frame
Within 3 months after the trial complete
Title
Menstrual improvement
Description
Menstrual improvement in number of days with bleeding or spotting
Time Frame
Within 3 months after the trial complete
Title
Menstrual improvement
Description
Menstrual improvement in monthly rates of amenorrhea
Time Frame
Within 3 months after the trial complete
Secondary Outcome Measure Information:
Title
Sex hormone levels
Description
mainly FSH, LH，E2 and AMH
Time Frame
Within 3 months after the trial complete
Title
AFC
Description
Changes in AFC in pelvic ultrasonography
Time Frame
Within 3 months after the trial complete
Title
SF-36
Description
The change of the MOS item short from health survey
Time Frame
Within 3 months after the trial complete

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Facility Information:
Facility Name
Lei Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei L Li, MD
Phone
13911988831
Ext
＋86
Email
lileigh@163.com
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
1000730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aijun Sun
Phone
01018600045466

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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