NCT06089395

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

October 4, 2023

Last Update Submit

April 30, 2024

Conditions

Poor Ovarian Response

Keywords

Poor Ovarian ResponseOvarian functionJiajian Guishen granules

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Follicle-stimulating hormone（FSH）

    before treatment and the first menstrual period 2-4 days after treatment

  • Luteinizing hormone（LH）

    before treatment and the first menstrual period 2-4 days after treatment

  • Estrogen (E2)

    before treatment and the first menstrual period 2-4 days after treatment

  • Progesterone (P)

    before treatment and the first menstrual period 2-4 days after treatment

  • Testosterone（T）

    before treatment and the first menstrual period 2-4 days after treatment

  • +5 more secondary outcomes

Study Arms (2)

Jiajian Guishen granules group

EXPERIMENTAL

Jiajian Guishen granules + coenzyme Q10 simulant

Drug: Jiajian Guishen granules

coenzyme Q10 group

ACTIVE COMPARATOR

Jiajian Guishen granules simulant+ coenzyme Q10

Drug: coenzyme Q10

Interventions

Jiajian Guishen granulesDRUG

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

Also known as: JJGS
Jiajian Guishen granules group
coenzyme Q10DRUG

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

Also known as: CoQ10
coenzyme Q10 group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dongzhimen Hospital of Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100700, China

Location

Chaoyang Hospital Affiliated to Capital Medical University

Beijing, China

Location

MeSH Terms

Interventions

coenzyme Q10

Study Officials

  • Shi Y Shi Yun, phD

    Dongzhimen Hospital of Beijing University of Chinese Medicine

    STUDY DIRECTOR

  • Wang CM Wang Chunmei, phD

    Dongzhimen Hospital of Beijing University of Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Shi X Shi Xiao, phD

    Capital Medical University

    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

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Central Study Contacts

Shi Y Shi Yun, phD

CONTACT

13717926522zhyshiyun@126.com

Shao JY Shao Jingyi, Master

CONTACT

15757395512shao_ritta@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Stratified Block Group Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of Gynecology

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 18, 2023

Study Start

June 1, 2024

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
IPD is available from Aug 2025 for 5 years
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.
More information

Locations

CN(2)