Clinical trial NCT05021094: Clinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction
Official title: A Multi-center Clinical Study on the Efficacy and Safety of Kuntai Capsule Alone and in Combination With Hormones in the Treatment of Early-onset Hypoovarian Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Primary Ovarian Insufficiency
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Subclinical POI and POI patients
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. The women aged \<40 years old.
2. 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.
3. Individuals meeting the above criteria who voluntarily consented to study participation.

Exclusion Criteria:

1. Pregnant and lactating patients;
2. Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids, endometrial polyps, etc.), hysteromyoma \> 4cm or hysterectomy;
3. Patients with known or suspected breast cancer history and estrogen-dependent malignant tumor;
4. 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);
5. Patients with porphyria;
6. Patients with serious primary diseases or mental illness such as cardiovascular, liver, kidney and hematopoietic system;
7. Patients who are participating in other clinical trials or have participated in other clinical trials in the past three months;
8. Patients who suspect or have a history of alcohol and drug abuse;
9. Patients who are known to be allergic to the test drugs or their components;
10. The researchers determined that patients are not suitable for this trial.

Primary outcomes:
measure: Follicle-stimulating hormone (FSH)
timeFrame: Baseline, 3 months, 6 months
measure: Kupperman Score
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Luteinizing hormone (LH)
timeFrame: Baseline, 3 months, 6 months
measure: Estradiol hormone (E2)
timeFrame: Baseline, 3 months, 6 months
measure: Antral follicle count (AFC)
timeFrame: Baseline, 3 months,
measure: anti-Müllerian hormone (AMH)
timeFrame: Baseline, 3 months,
measure: The peak systolic blood flow velocity （PSV）
timeFrame: Baseline, 3 months,
measure: The end-diastolic blood flow velocity（EDV）
timeFrame: Baseline, 3 months,
measure: Uterine artery resistance index（RI）
timeFrame: Baseline, 3 months,
measure: Proportion of patients with normal menstruation
timeFrame: Baseline，3 months, 6 months, 9 months
measure: Pregnancy situation
timeFrame: 6 months
Other outcomes:
Locations:
city: Hai'an
country: China
facility: Hai'an People's Hospital
state: Jiangsu
city: Huai'an
country: China
facility: Hai'an Hospital of traditional Chinese Medicine
state: Jiangsu
city: Nantong
country: China
facility: Nantong First People's Hospital
state: Jiangsu
city: Nantong
country: China
facility: Nantong Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Ru'gao
country: China
facility: Rugao Boai Hospital
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Yuquan Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: