The Effect of Jiajian Guishen Granules on the Modulation of Ovarian Function in Patients With Poor Ovarian Response(POR)

Last updated: April 30, 2024
Sponsor: Shi Yun
Overall Status: Active - Not Recruiting

Phase

1

Condition

N/A

Treatment

coenzyme Q10

Jiajian Guishen granules

Clinical Study ID

NCT06089395
JJGS on POR
  • Ages 20-45
  • Female

Study Summary

Relying on the Department of Gynecology of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine and chaoyang hospital of Capital medical university, this randomized controlled clinical study was carried out to investigate the application of kidney tonifying herbs to patients with poor ovarian response(POR).

A total of 76 patients with POR were collected and stratified district groups were randomly divided into a test group and a control group, with 38 patients included in each group. The experimental group was intervented with JJGS granules + coenzyme Q10 simulant, and the control group was intervened with coenzyme Q10 + JJGS granules simulant. AMH, serum basal sex hormone, AFC, TCM syndrome score, modified Kupperman scale and pregnancy status were observed before and after treatment to investigate the effects of Jiajian Guishen granules on the ovarian function of POR patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Woman who meet the diagnostic criteria for poor ovarian response;
  2. Woman who meet the TCM diagnostic criteria for kidney deficiency;
  3. Woman whose serum basal FSH(two consecutive menstrual cycles)between 10-25mIU/mL
  4. Woman whose AMH <1.1ng/ml;
  5. Woman aged ranged from 20-45 years old
  6. Woman whose body mass index (BMI)<35 kg/m2
  7. Womanwho voluntarily signed the informed consent form.

Exclusion

Exclusion Criteria:

  1. Woman who have combination of serious diseases such as cardiovascular,cerebrovascular, hepatic, renal and hematopoietic systems, and malignant tumors;
  2. Woman who have other endocrine diseases, such as polycystic ovary syndrome andhyperprolactinemia;
  3. Woman who are unable to cooperate with the treatment and follow-up, such as combinedneurological and psychiatric disorders, or those who are unwilling to cooperate.
  4. Woman who have used the same efficacy of herbs or other therapies in the last 1 month;
  5. Woman who are allergic to the drugs used in this study.

Study Design

Total Participants: 76
Treatment Group(s): 2
Primary Treatment: coenzyme Q10
Phase: 1
Study Start date:
June 01, 2024
Estimated Completion Date:
August 31, 2025

Study Description

This study was a multicenter, stratified block randomized, double-blind, double simulation, positive controlled clinical trial.

Connect with a study center

  • Dongzhimen Hospital of Beijing University of Chinese Medicine

    Beijing, Beijing 100700
    China

    Site Not Available

  • Xiyuan Hospital, China Academy of Traditional Chinese Medicine

    Beijing, Beijing 100700
    China

    Site Not Available

  • Chaoyang Hospital Affiliated to Capital Medical University

    Beijing,
    China

    Site Not Available

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