Clinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction

Primary Ovarian Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05021094
• Other study ID #: AHNantong-POI
• Status: Recruiting
• Phase: Phase 4
• Start date: October 22, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Affiliated Hospital of Nantong University
• Contact: Yuquan Zhang, Professor
• Phone: +8613706299363
• Email: jsnt_zhangyuquan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause, Premature
• Primary Ovarian Insufficiency

Intervention

Drug:
• Kuntai Capsule
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.
• Femoston
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.

Locations

Country	Name	City	State
China	Hai'an People's Hospital	Hai'an	Jiangsu
China	Hai'an Hospital of traditional Chinese Medicine	Huai'an	Jiangsu
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Nantong First People's Hospital	Nantong	Jiangsu
China	Nantong Hospital of Traditional Chinese Medicine	Nantong	Jiangsu
China	Rugao Boai Hospital	Ru'gao	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Follicle-stimulating hormone (FSH)	Changes of the level of FSH before and after treatment	Baseline, 3 months, 6 months
Primary	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	Baseline, 3 months, 6 months
Secondary	Luteinizing hormone (LH)	Changes of the level of LH before and after treatment	Baseline, 3 months, 6 months
Secondary	Estradiol hormone (E2)	Changes of the level of Estradiol hormone before and after treatment	Baseline, 3 months, 6 months
Secondary	Antral follicle count (AFC)	Changes of the AFC before and after treatment	Baseline, 3 months,
Secondary	anti-Müllerian hormone (AMH)	Changes of the level of AMH before and after treatment	Baseline, 3 months,
Secondary	The peak systolic blood flow velocity (PSV)	The peak systolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound	Baseline, 3 months,
Secondary	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	Baseline, 3 months,
Secondary	Uterine artery resistance index(RI)	The uterine artery resistance index before and after treatment was assessed by vaginal B ultrasound	Baseline, 3 months,
Secondary	Proportion of patients with normal menstruation	To measure the ratio of patients have normal menstruation after treatment	Baseline,3 months, 6 months, 9 months
Secondary	Pregnancy situation	To ask the patient if there is pregnancy (for patient who has pregnancy need)	6 months