Clinical、metabolomics and the Study of Intestinal Flora of Jinfeng Pills in the Treatment of Polycystic Ovary Syndrome

NCT ID: NCT06823830

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-02-28

Brief Summary

The goal of this clinical trial is to compare the clinical effect of Jinfeng Pill and Diane-35 in patients with PCOS. The main questions it aims to answer are: a. Comparison of the efficacy of the drugs separately and in combination. To explore the possible mechanism of Jinfeng pills. Participants will be treated for three months with monthly follow-up. Blood and stool samples should be collected.

Detailed Description

In this study, the clinical efficacy of Jinfeng pill in the treatment of PCOS was evaluated, and the clinical systems biology research system was introduced to discuss the clinical mechanism of Jinfeng pill in the treatment of PCOS from the perspectives of metabolomics and intestinal flora, etc., and an integrated biomarker index system was established to evaluate the efficacy of Jinfeng pill in the treatment of PCOS. To clarify the action mechanism and pharmacodynamic material basis of Jinfeng pills in treating PCOS. According to the previous study, a total of 105 participants were included. They were required to complete three months of treatment and monthly follow-up visits. The main therapeutic index was improved level of sex hormone. Secondary efficacy indexes included symptom scale score and TCM scale score. It has also been explored to incorporate changes such as metabolomic molecules and gut microbiota.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Jinfeng Pill Group

Group Type: EXPERIMENTAL

Jinfeng Pill

Intervention Type: DRUG

Jinfeng pills were compared with Diane-35 group and Jinfeng pills combined with Diane-35 group were compared with Diane-35 alone.

Jinfeng pill+Diane-35 Group

Group Type: EXPERIMENTAL

Jinfeng Pill

Intervention Type: DRUG

Jinfeng pills were compared with Diane-35 group and Jinfeng pills combined with Diane-35 group were compared with Diane-35 alone.

Jinfeng Pill(placebo)+Diane-35 Group

Group Type: ACTIVE_COMPARATOR

Jinfeng Pill

Intervention Type: DRUG

Jinfeng pills were compared with Diane-35 group and Jinfeng pills combined with Diane-35 group were compared with Diane-35 alone.

Interventions

Jinfeng Pill

Jinfeng pills were compared with Diane-35 group and Jinfeng pills combined with Diane-35 group were compared with Diane-35 alone.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Meet the diagnostic criteria for PCOS: refer to the 2003 Rotterdam standard.

2. In the past 1 month, no relevant drugs or surgery were used, including periodic use of progesterone, short-acting compound oral contraceptives, sequential treatment of estrogen progesterone, spironolactone, pioglitazone, acarboxylose, and related Chinese medicine.

3. Subjects (or their legal representatives) must understand the nature of the study and sign informed consent.

4. Patients with other chronic diseases under stable control should maintain the original treatment regimen during the study period.

Exclusion Criteria

1. Patients with other endocrine diseases, such as adrenal cortical hyperplasia or tumor, Cushing's syndrome, thyroid disease, hyperprolactinemia, androgen secreting tumors, etc.;

2. Patients who have used related drugs in the past 1 month, including sex hormone drugs, insulin sensitizers, including metformin, liraglutide and other drugs;

3. Substance abuse or dependence (alcohol or drugs) within the past 3 months; Heavy smokers (smokers who smoke 20 or more cigarettes a day);

4. Patients with serious or unstable physical diseases, including liver, kidney, gastrointestinal, cardiovascular, respiratory, endocrine, neurological, immune or blood system diseases, mental disorders;

5. Lactating or pregnant women, or women within 1 year after childbirth;

6. Previous allergy to the experimental drug;

7. History of thromboembolic disease or tendency to thrombosis;

8. Participated in a clinical trial of another investigational drug within 1 month prior to inclusion in this study (first interview);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

JFPILL202306

Identifier Type: -

Identifier Source: org_study_id