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

NCT05312190 | Unknown DMC

• 1 other identifier: ZhenQi202201
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 2

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.

Conditions

Menstrual Disorders

Keywords

Menstrual disorders; Traditional Chinese medicine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Sex hormone levels

  Within 3 months after the trial complete

• AFC

  Within 3 months after the trial complete

• SF-36

  Within 3 months after the trial complete

Study Arms (3)

Zhenqi Buxue Oral Liquid

EXPERIMENTAL

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 and Progesterone Capsules

EXPERIMENTAL

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; Drug: Progesterone Capsules

Progesterone Capsules

ACTIVE COMPARATOR

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

Drug: Progesterone Capsules

Interventions

ZhenQi BuXue KouFuYe DRUG

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.

Zhenqi Buxue Oral Liquid; Zhenqi Buxue Oral Liquid and Progesterone Capsules

Progesterone Capsules DRUG

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

Progesterone Capsules; Zhenqi Buxue Oral Liquid and Progesterone Capsules

Eligibility Criteria

• Age: 25 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

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

Study Sites (2)

Lei Li

Beijing, Beijing Municipality, 10000, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 1000730, China

RECRUITING

MeSH Terms

Conditions

Menstruation Disturbances

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 5, 2022
• Study Start: March 15, 2022
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: April 5, 2022

Record last verified: 2022-03

Locations

CN (2)