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| Name | Class |
|---|---|
| Capital Medical University | OTHER |
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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.
This study was a multicenter, stratified block randomized, double-blind, double simulation, positive controlled clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jiajian Guishen granules group | Experimental | Jiajian Guishen granules + coenzyme Q10 simulant |
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| coenzyme Q10 group | Active Comparator | Jiajian Guishen granules simulant+ coenzyme Q10 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jiajian Guishen granules | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shi Y Shi Yun, phD | Contact | 13717926522 | zhyshiyun@126.com | |
| Shao JY Shao Jingyi, Master | Contact | 15757395512 | shao_ritta@163.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital of Beijing University of Chinese Medicine | Beijing | Beijing Municipality | 100700 | China |
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 is available from Aug 2025 for 5 years
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.
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| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
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A Stratified Block Group Randomized Controlled Study
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| coenzyme Q10 | 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 |
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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 |
| 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 |
| Chaoyang Hospital Affiliated to Capital Medical University | Beijing | China |
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