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

A Randomized and Double-blind Clinical Trial of Jiajian Guishen Granules on the Modulation of Ovarian Function in Patients With Poor Ovarian Response

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Poor Ovarian Response
• Intervention / Treatment: Drug: Jiajian Guishen granules; Drug: coenzyme Q10

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Shi Y Shi Yun, phD; Phone Number: 13717926522; Email: zhyshiyun@126.com
• Study Contact Backup: Name: Shao JY Shao Jingyi, Master; Phone Number: 15757395512; Email: shao_ritta@163.com

Study Locations

• China
  • Beijing, China
    • Chaoyang Hospital Affiliated to Capital Medical University
    • Contact: Shi X Xiao, phD; Phone Number: 18610292768; Email: shixiao@163.com
    • Principal Investigator: Shi X Xiao, phD
  • Beijing
    • Beijing, Beijing, China, 100700
      • Dongzhimen Hospital of Beijing University of Chinese Medicine
      • Contact: Han XT Han Xueting; Phone Number: 01084012709; Email: dzmyyec@126.com
      • Principal Investigator: Shi Y Shi Yun, phD
      • Sub-Investigator: Wang CM Wang Chunmei, phD
      • Sub-Investigator: Yang QH Yang Qiaohui, phD
      • Sub-Investigator: Yan QY Yan Qingya, phD
      • Sub-Investigator: Shao JY Shao Jingyi, Master
      • Sub-Investigator: Xu K Xu Ke, Master
      • Sub-Investigator: Li XY Li Xiyu, Bachelor
      • Sub-Investigator: Liu QY Liu Qinyang, Bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jiajian Guishen granules group; Jiajian Guishen granules + coenzyme Q10 simulant	Drug: 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; Other Names: JJGS
Active Comparator: coenzyme Q10 group; Jiajian Guishen granules simulant+ coenzyme Q10	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; Other Names: CoQ10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-Miller's Tube Hormone（AMH）	The unit is ng/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, anti-mullerian hormone (AMH) was measured by radioimmunoassay	before treatment and the first menstrual period 2-4 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follicle-stimulating hormone（FSH）	The unit is mIU/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, FSH were measured by radioimmunoassay.	before treatment and the first menstrual period 2-4 days after treatment
Luteinizing hormone（LH）	The unit is mIU/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, LH were measured by radioimmunoassay.	before treatment and the first menstrual period 2-4 days after treatment
Estrogen (E2)	The unit is pg/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, E2 were measured by radioimmunoassay.	before treatment and the first menstrual period 2-4 days after treatment
Progesterone (P)	The unit is ng/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, P were measured by radioimmunoassay.	before treatment and the first menstrual period 2-4 days after treatment
Testosterone（T）	The unit is ng/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, T were measured by radioimmunoassay.	before treatment and the first menstrual period 2-4 days after treatment
antral follicle count（AFC）	Color Doppler ultrasound was performed in the early follicular phase in the usual way to observe the number of follicles in the underlying sinuses.	before treatment and early follicular phase in the first post-treatment menstrual cycle day 1
Traditional Chinese Medicine Score	The main symptoms include menstrual cycle, menstrual flow reduction. Scoring criteria: ① normal menstrual cycle 0 points, 1-2 weeks ahead or behind the wrong 4 points, 2-3 weeks 8 points, more than 3 weeks 12 points; ② menstrual flow than the previous menstrual flow no change 0 points, menstrual flow reduction ≤ ⅓ 4 points, ⅓ < menstrual flow reduction ≤ ½ 8 points, menstrual flow reduction > ½ 12 points. Secondary symptoms included lumbar and knee pain, dizziness and tinnitus, loss of libido, increased urination, hot flashes and night sweats, and lower back and lower limb pain. According to the degree of aggravation of symptoms, the total score was assigned as 0,2,4,8. The sum of the scores of the main symptoms and secondary symptoms, the higher the score, the more serious the TCM symptoms.	baseline and immediately after treatment
Modified Kupperman rating scale	Referring to the domestic modified Kupperman Symptom Scoring Criteria in Chinese Obstetrics and Gynecology, edited by Cao Zeyi, to observe and rate perimenopausal symptoms before and after treatment and to quantify the degree of decline in ovarian function.Entries include hot flashes and sweating, sensory abnormalities, insomnia, anxiety and depression, dizziness, fatigue, muscle and joint pain, headache, palpitations, ankylosis of the skin, sexual discomfort, and urinary irritation, with different coefficients for each entry, and according to the aggravating degree of the symptom, they are divided into 0, 1, 2, and 3 points, and the coefficients corresponding to the scoring of the degree of each item are multiplied by a fixed score of the symptom to add up to the total score, and the higher the total score suggests that the symptoms of the perimenopausal period are more serious.	baseline and immediately after treatment
Clinical pregnancy rate	Defined as the number of women with identified clinical pregnancies divided by the number of patients randomized to a specific group. Clinical pregnancy is confirmed when 1 or more ges-tational sacs are detected on transvaginal ultrasound assessment.	up to 6 months
Early miscarriage rate	Defined as the per-centage of participants with loss of a diagnosed clinical pregnancy before 12 weeks gestation to the total patients randomized	up to 6 months

Collaborators and Investigators

• Sponsor: Shi Yun
• Collaborators: Capital Medical University
• Investigators: Study Director: Shi Y Shi Yun, phD, Dongzhimen Hospital of Beijing University of Chinese Medicine; Principal Investigator: Wang CM Wang Chunmei, phD, Dongzhimen Hospital of Beijing University of Chinese Medicine; Principal Investigator: Yang QH Yang Qiaohui, pdD, Dongzhimen Hospital of Beijing University of Chinese Medicine; Principal Investigator: Yan QY Yan Qingya, phD, Dongzhimen Hospital of Beijing University of Chinese Medicine; Study Chair: Shao JY Shao Jingyi, Master, Dongzhimen Hospital of Beijing University of Chinese Medicine; Study Chair: Xu K Xu Ke, Master, Dongzhimen Hospital of Beijing University of Chinese Medicine; Study Chair: Li XY Li Xiyu, Bachelor, Dongzhimen Hospital of Beijing University of Chinese Medicine; Study Chair: Liu QY Liu Qinyang, Bachelor, Dongzhimen Hospital of Beijing University of Chinese Medicine; Principal Investigator: Shi X Shi Xiao, phD, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Poor Ovarian Response; Ovarian function; Jiajian Guishen granules
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: JJGS on POR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share the protocol and progress of the clinical trial, and will share the clinical study report when we have completed patient collection and treatment.
• IPD Sharing Time Frame: IPD is available from Aug 2025 for 5 years
• IPD Sharing Access Criteria: All investigators can check through the public management platform of clinical trials, or contact the investigators of this trial to obtain IPDs including clinical trial protocols and clinical trial reports.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No