Clinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction
- Conditions
- Primary Ovarian Insufficiency
- Interventions
- Registration Number
- NCT05021094
- Lead Sponsor
- Affiliated Hospital of Nantong University
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 120
- The women aged <40 years old.
- Serum basal follicle stimulating hormone (FSH) level ≥15 IU/L at least twice inspection (two occasions >4 weeks apart). Rare menstruation or menopause for at least 4 months.
- Individuals meeting the above criteria who voluntarily consented to study participation.
- Pregnant and lactating patients;
- Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids, endometrial polyps, etc.), hysteromyoma > 4cm or hysterectomy;
- Patients with known or suspected breast cancer history and estrogen-dependent malignant tumor;
- Patients with personal history of venous thromboembolism (VTE) or high risk of VTE (including body mass index > 30 kg/m2, smoking and family history of thrombosis);
- Patients with porphyria;
- Patients with serious primary diseases or mental illness such as cardiovascular, liver, kidney and hematopoietic system;
- Patients who are participating in other clinical trials or have participated in other clinical trials in the past three months;
- Patients who suspect or have a history of alcohol and drug abuse;
- Patients who are known to be allergic to the test drugs or their components;
- The researchers determined that patients are not suitable for this trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description POI patients who taking Kuntai capsule Kuntai Capsule Patients in this group will take Kuntai capsule orally, 4 capsules each time, 3 times a day, and take the medicine for 3 courses. POI patients who taking Kuntai capsule combined with hormone therapy Kuntai Capsule Kuntai capsule was taken at the same dose as Kuntai group on the basis of hormone therapy for 3 courses. Subclinical POI patients who taking Kuntai capsule Kuntai Capsule Subclinical POI patients in this group which with Kuntai capsule intervention. This group is a self-controlled experiment before and after treatment POI patients who accepting hormone therapy Femoston The estrogen and progesterone sequential regimen was adopted. The drug was estradiol tablets/estradiol didroxyprogesterone tablets (Femoston). Red tablets (estradiol, 2mg/d) were taken in the first 14 days, and gray tablets (estradiol, 2mg/d, dydrogesterone,10 mg/d) were taken in the last 14 days. 28 days was a course of treatment, and 3 courses of treatment were taken. POI patients who taking Kuntai capsule combined with hormone therapy Femoston Kuntai capsule was taken at the same dose as Kuntai group on the basis of hormone therapy for 3 courses.
- Primary Outcome Measures
Name Time Method Follicle-stimulating hormone (FSH) Baseline, 3 months, 6 months Changes of the level of FSH before and after treatment
Kupperman Score Baseline, 3 months, 6 months 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
- Secondary Outcome Measures
Name Time Method Luteinizing hormone (LH) Baseline, 3 months, 6 months Changes of the level of LH before and after treatment
Antral follicle count (AFC) Baseline, 3 months, Changes of the AFC before and after treatment
The peak systolic blood flow velocity （PSV） Baseline, 3 months, The peak systolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound
The end-diastolic blood flow velocity（EDV） Baseline, 3 months, The uterine artery end-diastolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound
anti-Müllerian hormone (AMH) Baseline, 3 months, Changes of the level of AMH before and after treatment
Estradiol hormone (E2) Baseline, 3 months, 6 months Changes of the level of Estradiol hormone before and after treatment
Uterine artery resistance index（RI） Baseline, 3 months, The uterine artery resistance index before and after treatment was assessed by vaginal B ultrasound
Proportion of patients with normal menstruation Baseline，3 months, 6 months, 9 months To measure the ratio of patients have normal menstruation after treatment
Pregnancy situation 6 months To ask the patient if there is pregnancy (for patient who has pregnancy need)
Trial Locations
- Locations (6)
Hai'an Hospital of traditional Chinese Medicine
🇨🇳Huai'an, Jiangsu, China
Nantong Hospital of Traditional Chinese Medicine
🇨🇳Nantong, Jiangsu, China
Rugao Boai Hospital
🇨🇳Ru'gao, Jiangsu, China
Nantong First People's Hospital
🇨🇳Nantong, Jiangsu, China
Hai'an People's Hospital
🇨🇳Hai'an, Jiangsu, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China