Status:
NOT_YET_RECRUITING
The Effect of Jiajian Guishen Granules on the Modulation of Ovarian Function in Patients With Poor Ovarian Response(POR)
Lead Sponsor:
Shi Yun
Collaborating Sponsors:
Capital Medical University
Conditions:
Poor Ovarian Response
Eligibility:
FEMALE
20-45 years
Phase:
EARLY_PHASE1
Brief 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 cli...
Detailed Description
This study was a multicenter, stratified block randomized, double-blind, double simulation, positive controlled clinical trial.
Eligibility Criteria
Inclusion
- Woman who meet the diagnostic criteria for poor ovarian response;
- Woman who meet the TCM diagnostic criteria for kidney deficiency;
- Woman whose serum basal FSH(two consecutive menstrual cycles)between 10-25mIU/mL
- Woman whose AMH \<1.1ng/ml;
- Woman aged ranged from 20-45 years old
- Woman whose body mass index (BMI)\<35 kg/m2
- Womanwho voluntarily signed the informed consent form.
Exclusion
- Woman who have combination of serious diseases such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems, and malignant tumors;
- Woman who have other endocrine diseases, such as polycystic ovary syndrome and hyperprolactinemia;
- Woman who are unable to cooperate with the treatment and follow-up, such as combined neurological and psychiatric disorders, or those who are unwilling to cooperate.
- Woman who have used the same efficacy of herbs or other therapies in the last 1 month;
- Woman who are allergic to the drugs used in this study.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06089395
Start Date
June 1 2024
End Date
August 31 2025
Last Update
May 2 2024
Active Locations (2)
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1
Dongzhimen Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China, 100700
2
Chaoyang Hospital Affiliated to Capital Medical University
Beijing, China