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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Poor Ovarian Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Stratified Block Group Randomized Controlled Study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Jiajian Guishen granules group

Jiajian Guishen granules + coenzyme Q10 simulant

Group Type EXPERIMENTAL

Jiajian Guishen granules

Intervention Type DRUG

This study was a stratified district group randomized, double-blind, double simulation, positive control clinical trial with JJGS granules + coenzyme Q10 simulant in the test group and JJGS granules simulant + coenzyme Q10 in the control group

coenzyme Q10 group

Jiajian Guishen granules simulant+ coenzyme Q10

Group Type ACTIVE_COMPARATOR

coenzyme Q10

Intervention Type DRUG

This study was a stratified district group randomized, double-blind, double simulation, positive control clinical trial with JJGS granules + coenzyme Q10 simulant in the test group and JJGS granules simulant + coenzyme Q10 in the control group

Interventions

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Jiajian Guishen granules

This study was a stratified district group randomized, double-blind, double simulation, positive control clinical trial with JJGS granules + coenzyme Q10 simulant in the test group and JJGS granules simulant + coenzyme Q10 in the control group

Intervention Type DRUG

coenzyme Q10

This study was a stratified district group randomized, double-blind, double simulation, positive control clinical trial with JJGS granules + coenzyme Q10 simulant in the test group and JJGS granules simulant + coenzyme Q10 in the control group

Intervention Type DRUG

Other Intervention Names

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JJGS CoQ10

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No