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

Shi Yun

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Poor Ovarian Response

Treatments: Drug: Jiajian Guishen granules; Drug: coenzyme Q10

Study type: Interventional

Funder types: Other

Identifiers

NCT06089395

JJGS on POR

Details and patient eligibility

About

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.

Full description

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

Enrollment: 76 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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 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 and hyperprolactinemia;
3. 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.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

Jiajian Guishen granules group

Experimental group

Description:

Jiajian Guishen granules + coenzyme Q10 simulant

Treatment:

Drug: Jiajian Guishen granules

coenzyme Q10 group

Active Comparator group

Description:

Jiajian Guishen granules simulant+ coenzyme Q10

Treatment:

Drug: coenzyme Q10