To evaluate the efficacy and safety of Kuntai capsule alone or combined with hormone therapy in improving ovarian function in POI patients (including subclinical stage).
The study is expected to be conducted between 2021.08 and 2023.12.120 subjects with early-onset ovarian insufficiency will be randomly assigned to trial, control, or combination groups using a computer-generated randomization table.By comparing the data of primary efficacy indexes, secondary efficacy indexes and safety indexes before and after medication, The principal investigator will write and publish the paper.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
The instructions is pointed that each Kuntai capsule is 0.5g and the usage of Kuntai capsule is oral taking 4 capsules each time, 3 times a day, and 4 weeks is a course of treatment. The patients will taking 3 courses of treatment in this study.
The estrogen and progesterone sequential regimen was adopted. The Femoston was contain estradiol tablets and estradiol didroxyprogesterone tablets. Red tablets (estradiol, 2 mg/d) were taken in the first 14 days, and gray tablets (estradiol, 2 mg/d, dydrogesterone,10 mg/d) were taken in the last 14 days. 28 days was a course of treatment, and three courses of treatment were taken. The patients will taking 3 courses of treatment in this study.
Hai'an People's Hospital
Hai’an, Jiangsu, China
RECRUITINGHai'an Hospital of traditional Chinese Medicine
Huai'an, Jiangsu, China
RECRUITINGNantong First People's Hospital
Nantong, Jiangsu, China
Follicle-stimulating hormone (FSH)
Changes of the level of FSH before and after treatment
Time frame: Baseline, 3 months, 6 months
Kupperman Score
Changes of the Kupperman score before and after treatment,Kupperman Score ranges from 0 to 69, with the smaller the score, the better off the subject
Time frame: Baseline, 3 months, 6 months
Luteinizing hormone (LH)
Changes of the level of LH before and after treatment
Time frame: Baseline, 3 months, 6 months
Estradiol hormone (E2)
Changes of the level of Estradiol hormone before and after treatment
Time frame: Baseline, 3 months, 6 months
Antral follicle count (AFC)
Changes of the AFC before and after treatment
Time frame: Baseline, 3 months,
anti-Müllerian hormone (AMH)
Changes of the level of AMH before and after treatment
Time frame: Baseline, 3 months,
The peak systolic blood flow velocity (PSV)
The peak systolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound
Time frame: Baseline, 3 months,
The end-diastolic blood flow velocity(EDV)
The uterine artery end-diastolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound
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Nantong Hospital of Traditional Chinese Medicine
Nantong, Jiangsu, China
RECRUITINGAffiliated Hospital of Nantong University
Nantong, Jiangsu, China
RECRUITINGRugao Boai Hospital
Ru'gao, Jiangsu, China
RECRUITINGTime frame: Baseline, 3 months,
Uterine artery resistance index(RI)
The uterine artery resistance index before and after treatment was assessed by vaginal B ultrasound
Time frame: Baseline, 3 months,
Proportion of patients with normal menstruation
To measure the ratio of patients have normal menstruation after treatment
Time frame: Baseline,3 months, 6 months, 9 months
Pregnancy situation
To ask the patient if there is pregnancy (for patient who has pregnancy need)
Time frame: 6 months