Clinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction
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
1 other identifier
interventional
120
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2021
Typical duration for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2021
CompletedFirst Posted
Study publicly available on registry
August 25, 2021
CompletedStudy Start
First participant enrolled
October 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedSeptember 9, 2022
September 1, 2022
2.2 years
August 4, 2021
September 8, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Follicle-stimulating hormone (FSH)
Changes of the level of FSH before and after treatment
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
Baseline, 3 months, 6 months
Secondary Outcomes (9)
Luteinizing hormone (LH)
Baseline, 3 months, 6 months
Estradiol hormone (E2)
Baseline, 3 months, 6 months
Antral follicle count (AFC)
Baseline, 3 months,
anti-Müllerian hormone (AMH)
Baseline, 3 months,
The peak systolic blood flow velocity （PSV）
Baseline, 3 months,
- +4 more secondary outcomes
Study Arms (4)
POI patients who taking Kuntai capsule
EXPERIMENTALPatients 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 accepting hormone therapy
ACTIVE COMPARATORThe 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
EXPERIMENTALKuntai 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
EXPERIMENTALSubclinical POI patients in this group which with Kuntai capsule intervention. This group is a self-controlled experiment before and after treatment
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hai'an People's Hospital
Hai’an, Jiangsu, 226600, China
Hai'an Hospital of traditional Chinese Medicine
Huai'an, Jiangsu, 226600, China
Nantong First People's Hospital
Nantong, Jiangsu, 226001, China
Nantong Hospital of Traditional Chinese Medicine
Nantong, Jiangsu, 226001, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Rugao Boai Hospital
Ru'gao, Jiangsu, 226500, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuquan Zhang, Professor
Affiliated Hospital of Nantong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- blind experiment
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Obstetrics and Gynaecology
Study Record Dates
First Submitted
August 4, 2021
First Posted
August 25, 2021
Study Start
October 22, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
September 9, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share
Not planning sharing at present.