NCT06823830

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

February 12, 2025

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

July 11, 2023

Last Update Submit

February 8, 2025

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Sex hormone

    FSH、 LH、 E2、 T、 PRL、 DS、 AMH

    twice (before and after 3-month treatment)

Secondary Outcomes (5)

  • Menstrual status

    everyday during 3-month treatment

  • acne score

    twice (before and after 3-month treatment)

  • hirsutism score

    twice (before and after 3-month treatment)

  • Traditional Chinese Medicine Symptom Score

    every month during 3-month treatment

  • 36-Item Short Form Survey

    every month during 3-month treatment

Study Arms (3)

Jinfeng Pill Group

EXPERIMENTAL
Drug: Jinfeng Pill

Jinfeng pill+Diane-35 Group

EXPERIMENTAL
Drug: Jinfeng Pill

Jinfeng Pill(placebo)+Diane-35 Group

ACTIVE COMPARATOR
Drug: Jinfeng Pill

Interventions

Jinfeng PillDRUG

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

Jinfeng Pill GroupJinfeng Pill(placebo)+Diane-35 GroupJinfeng pill+Diane-35 Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meet the diagnostic criteria for PCOS: refer to the 2003 Rotterdam standard.
  • 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.
  • Subjects (or their legal representatives) must understand the nature of the study and sign informed consent.
  • Patients with other chronic diseases under stable control should maintain the original treatment regimen during the study period.

You may not qualify if:

  • Patients with other endocrine diseases, such as adrenal cortical hyperplasia or tumor, Cushing's syndrome, thyroid disease, hyperprolactinemia, androgen secreting tumors, etc.;
  • Patients who have used related drugs in the past 1 month, including sex hormone drugs, insulin sensitizers, including metformin, liraglutide and other drugs;
  • Substance abuse or dependence (alcohol or drugs) within the past 3 months; Heavy smokers (smokers who smoke 20 or more cigarettes a day);
  • Patients with serious or unstable physical diseases, including liver, kidney, gastrointestinal, cardiovascular, respiratory, endocrine, neurological, immune or blood system diseases, mental disorders;
  • Lactating or pregnant women, or women within 1 year after childbirth;
  • Previous allergy to the experimental drug;
  • History of thromboembolic disease or tendency to thrombosis;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 1000730, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2023

First Posted

February 12, 2025

Study Start

September 1, 2023

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

February 12, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)