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

February 8, 2025 updated by: Peking Union Medical College Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sex hormone
Time Frame: twice (before and after 3-month treatment)
FSH、 LH、 E2、 T、 PRL、 DS、 AMH
twice (before and after 3-month treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Menstrual status
Time Frame: everyday during 3-month treatment
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
Time Frame: twice (before and after 3-month treatment)
applying Global Acne Grading System（GAGS）, scored by gynecologist
twice (before and after 3-month treatment)
hirsutism score
Time Frame: twice (before and after 3-month treatment)
applying Ferriman-Gallwey scoring system, scored by gynecologist
twice (before and after 3-month treatment)
Traditional Chinese Medicine Symptom Score
Time Frame: every month during 3-month treatment
patient self-assessment scale, in Chinese
every month during 3-month treatment
36-Item Short Form Survey
Time Frame: every month during 3-month treatment
SF-36 is a self-reported survey that assesses physical and mental health outcomes.
every month during 3-month treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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