NCT06823830

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2025-02-12
• Last updated: 2025-02-12

Locations

1 site across 1 country: China