Back to resultsClinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction
Primary Purpose
Primary Ovarian Insufficiency
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Kuntai Capsule
Femoston
Sponsored by
About this trial
This is an interventional treatment trial for Primary Ovarian Insufficiency
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Hai'an People's HospitalRecruiting
- Hai'an Hospital of traditional Chinese MedicineRecruiting
- Nantong First People's HospitalRecruiting
- Nantong Hospital of Traditional Chinese MedicineRecruiting
- Affiliated Hospital of Nantong UniversityRecruiting
- Rugao Boai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Experimental
Arm Label
POI patients who taking Kuntai capsule
POI patients who accepting hormone therapy
POI patients who taking Kuntai capsule combined with hormone therapy
Subclinical POI patients who taking Kuntai capsule
Arm Description
Patients in this group will take Kuntai capsule orally, 4 capsules each time, 3 times a day, and take the medicine for 3 courses.
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.
Kuntai capsule was taken at the same dose as Kuntai group on the basis of hormone therapy for 3 courses.
Subclinical POI patients in this group which with Kuntai capsule intervention. This group is a self-controlled experiment before and after treatment
Outcomes
Primary Outcome Measures
Follicle-stimulating hormone (FSH)
Changes of the level of FSH before and after treatment
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
Secondary Outcome Measures
Luteinizing hormone (LH)
Changes of the level of LH before and after treatment
Estradiol hormone (E2)
Changes of the level of Estradiol hormone before and after treatment
Antral follicle count (AFC)
Changes of the AFC before and after treatment
anti-Müllerian hormone (AMH)
Changes of the level of AMH before and after treatment
The peak systolic blood flow velocity （PSV）
The peak systolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound
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
Uterine artery resistance index（RI）
The uterine artery resistance index before and after treatment was assessed by vaginal B ultrasound
Proportion of patients with normal menstruation
To measure the ratio of patients have normal menstruation after treatment
Pregnancy situation
To ask the patient if there is pregnancy (for patient who has pregnancy need)
Full Information
NCT ID
NCT05021094
First Posted
August 4, 2021
Last Updated
September 8, 2022
Sponsor
Affiliated Hospital of Nantong University
1. Study Identification
Unique Protocol Identification Number
NCT05021094
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Nantong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Ovarian Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Model Description
Subclinical POI and POI patients
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
blind experiment
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
POI patients who taking Kuntai capsule
Arm Type
Experimental
Arm Description
Patients in this group will take Kuntai capsule orally, 4 capsules each time, 3 times a day, and take the medicine for 3 courses.
Arm Title
POI patients who accepting hormone therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
POI patients who taking Kuntai capsule combined with hormone therapy
Arm Type
Experimental
Arm Description
Kuntai capsule was taken at the same dose as Kuntai group on the basis of hormone therapy for 3 courses.
Arm Title
Subclinical POI patients who taking Kuntai capsule
Arm Type
Experimental
Arm Description
Subclinical POI patients in this group which with Kuntai capsule intervention. This group is a self-controlled experiment before and after treatment
Intervention Type
Drug
Intervention Name(s)
Kuntai Capsule
Other Intervention Name(s)
Kuntai Jiaonang
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Femoston
Other Intervention Name(s)
Complex Packing Estradiol Tablets/Estradiol and Dydrogesterone Tablets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Follicle-stimulating hormone (FSH)
Description
Changes of the level of FSH before and after treatment
Time Frame
Baseline, 3 months, 6 months
Title
Kupperman Score
Description
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
Secondary Outcome Measure Information:
Title
Luteinizing hormone (LH)
Description
Changes of the level of LH before and after treatment
Time Frame
Baseline, 3 months, 6 months
Title
Estradiol hormone (E2)
Description
Changes of the level of Estradiol hormone before and after treatment
Time Frame
Baseline, 3 months, 6 months
Title
Antral follicle count (AFC)
Description
Changes of the AFC before and after treatment
Time Frame
Baseline, 3 months,
Title
anti-Müllerian hormone (AMH)
Description
Changes of the level of AMH before and after treatment
Time Frame
Baseline, 3 months,
Title
The peak systolic blood flow velocity （PSV）
Description
The peak systolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound
Time Frame
Baseline, 3 months,
Title
The end-diastolic blood flow velocity（EDV）
Description
The uterine artery end-diastolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound
Time Frame
Baseline, 3 months,
Title
Uterine artery resistance index（RI）
Description
The uterine artery resistance index before and after treatment was assessed by vaginal B ultrasound
Time Frame
Baseline, 3 months,
Title
Proportion of patients with normal menstruation
Description
To measure the ratio of patients have normal menstruation after treatment
Time Frame
Baseline，3 months, 6 months, 9 months
Title
Pregnancy situation
Description
To ask the patient if there is pregnancy (for patient who has pregnancy need)
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuquan Zhang, Professor
Phone
+8613706299363
Email
jsnt_zhangyuquan@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Weina Wang, Postgraduate
Phone
13795242689
Email
451579895@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuquan Zhang, Professor
Organizational Affiliation
Affiliated Hospital of Nantong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hai'an People's Hospital
City
Hai'an
State/Province
Jiangsu
ZIP/Postal Code
226600
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Lu, master
Phone
13862711105
Facility Name
Hai'an Hospital of traditional Chinese Medicine
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
226600
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Chen, master
Phone
18934506298
Facility Name
Nantong First People's Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanli Zheng, Master
Phone
+8613962910099
Facility Name
Nantong Hospital of Traditional Chinese Medicine
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongmei C Chen, Master
Phone
13485105619
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanquan Zhang, Professor
Phone
+8613706299363
Email
jsnt_zhangyuquan@163.com
Facility Name
Rugao Boai Hospital
City
Ru'gao
State/Province
Jiangsu
ZIP/Postal Code
226500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sifang Zhang, bachelor
Phone
18752861616
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not planning sharing at present.
Learn more about this trial
Clinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction
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