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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: Jinfeng Pill

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.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 1000730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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);
9. Those who meet the inclusion criteria, do not follow medical advice, cannot judge the efficacy or have incomplete data to evaluate the efficacy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jinfeng Pill Group	Drug: Jinfeng Pill; Jinfeng pills were compared with Diane-35 group and Jinfeng pills combined with Diane-35 group were compared with Diane-35 alone.
Experimental: Jinfeng pill+Diane-35 Group	Drug: Jinfeng Pill; Jinfeng pills were compared with Diane-35 group and Jinfeng pills combined with Diane-35 group were compared with Diane-35 alone.
Active Comparator: Jinfeng Pill(placebo)+Diane-35 Group	Drug: Jinfeng Pill; Jinfeng pills were compared with Diane-35 group and Jinfeng pills combined with Diane-35 group were compared with Diane-35 alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex hormone	FSH、 LH、 E2、 T、 PRL、 DS、 AMH	twice (before and after 3-month treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual status	patients were asked to record the day they menstruating, menstruation duration and the flow level (light/ medium/ heavy) and concomitant symptom	everyday during 3-month treatment
acne score	applying Global Acne Grading System（GAGS）, scored by gynecologist	twice (before and after 3-month treatment)
hirsutism score	applying Ferriman-Gallwey scoring system, scored by gynecologist	twice (before and after 3-month treatment)
Traditional Chinese Medicine Symptom Score	patient self-assessment scale, in Chinese	every month during 3-month treatment
36-Item Short Form Survey	SF-36 is a self-reported survey that assesses physical and mental health outcomes.	every month during 3-month treatment

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: February 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 8, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Syndrome; Polycystic Ovary Syndrome
• Other Study ID Numbers: JFPILL202306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No