Back to resultsA Clinical Study of Chinese Herbal Compound TJAOA101 in the Treatment of Premature Ovarian Insufficiency
Primary Purpose
Premature Ovarian Failure
Status
Not yet recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
TJAOA101
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ovarian Failure focused on measuring Premature Ovarian Failure, Traditional Chinese Medicine
Eligibility Criteria
Inclusion Criteria:
- The age range of patient is 18-40 years old.
- The diagnostic criteria for POI is as follows: Age <40; and menopause or sporadic menstruation for more than 4 months; and bFSH>25 mIU/ml (the interval between two reexaminations should be more than one month, both reached this level)
- Sign the informed consent form.
Exclusion Criteria:
- Patient is known to be allergic or unsuitable for the Chinese herbal compound.
- Women who are pregnant and lactating.
- Patients had been menopause for more than 1 year.
- Abnormal uterine bleeding, except ovulation disorders.
- Women is taking hormone drugs and has stopped taking them within 3 months;
- Women with endometriosis, myadenosis, submucosal fibroids or the size of non- submucosal fibroids is more than 4 cm.
- The nature of pelvic mass is unknown.
- Women with polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, diabetes, thyroid and adrenal dysfunction and other endocrine diseases affecting ovulation.
- Patients with serious primary diseases such as cardiovascular, liver, kidney, lung, biliary, hematopoietic system (Hb<90g/L) and malignant tumor, and psychiatric patients.
- Patients are participating in other clinical trials or have participated in other clinical trials within the last month.
- Unsuitable for the study evaluated by the investigator.
Sites / Locations
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TJAOA101
Arm Description
Once enrolled, participants will be administrated TJAOA101 and followed by a 3-month medication cycle. The usage of this herbal compound is to take orally twice a day(two sacks per). Add it to about 200ml warm water and take it half an hour before breakfast in the morning and half an hour before bedtime in the evening except menstrual period.
Outcomes
Primary Outcome Measures
recovery rate of ovarian function
As the definition of POI is based on menstruation and bFSH, the recovery of ovarian function is also based on the recovery of these indicators. In this study, the recovery of ovarian function is defined as serum bFSH decreased more than 50%, or recover to normal level; or two consecutive periods return to normal.
Secondary Outcome Measures
serum AMH
serum AMH increased more than 50%, or recover to normal level.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05522634
Brief Title
A Clinical Study of Chinese Herbal Compound TJAOA101 in the Treatment of Premature Ovarian Insufficiency
Official Title
The Efficacy and Safety of Chinese Herbal Compound TJAOA101 in the Treatment of POI: A Multicenter, Prospective and Before-after Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Premature ovarian insufficiency (POI) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating POI. We have created a new Chinese herbal combination TJAOA101, whereas its safety and efficacy still need to be validated. Hence, we will perform a population-based, multicenter study to confirm the safety and efficacy of TJAOA101 in therapy of POI. We aim to provide a solid evidence for TCM in therapy of POI.
Detailed Description
Premature ovarian insufficiency (POI) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating POI. We have created a new Chinese herbal combination TJAOA101, whereas its safety and efficacy still need to be validated in multi-center and prospective clinical trials. We are conducting a prospective and before-after clinic trial with 100 eligible women aged 18-40 diagnosed POI will be participated. All participants will be administrated TJAOA101 drug twice every day for overall 3 months. The primary outcomes will be the basal level of serum FSH. The second outcome is the recovery rate of menstruation. All the outcomes will be assessed at baseline and 1, 2, 3 months following the 3 months' treatment. Adverse events(AEs) of patients will be assessed during the follow-up. The study was approved by the Medical Ethics Committee of the Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology (TJ-IRB20220634) according to the submitted study protocol (V.2.1, 10 May 2022) and informed consent (V.2.1, 10 May 2022). The results will be presented at domestic and international conferences and published in peer reviewed journals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ovarian Failure
Keywords
Premature Ovarian Failure, Traditional Chinese Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TJAOA101
Arm Type
Experimental
Arm Description
Once enrolled, participants will be administrated TJAOA101 and followed by a 3-month medication cycle. The usage of this herbal compound is to take orally twice a day(two sacks per). Add it to about 200ml warm water and take it half an hour before breakfast in the morning and half an hour before bedtime in the evening except menstrual period.
Intervention Type
Drug
Intervention Name(s)
TJAOA101
Intervention Description
Once enrolled, participants will be administrated TJAOA101
Primary Outcome Measure Information:
Title
recovery rate of ovarian function
Description
As the definition of POI is based on menstruation and bFSH, the recovery of ovarian function is also based on the recovery of these indicators. In this study, the recovery of ovarian function is defined as serum bFSH decreased more than 50%, or recover to normal level; or two consecutive periods return to normal.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
serum AMH
Description
serum AMH increased more than 50%, or recover to normal level.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The age range of patient is 18-40 years old.
The diagnostic criteria for POI is as follows: Age <40; and menopause or sporadic menstruation for more than 4 months; and bFSH>25 mIU/ml (the interval between two reexaminations should be more than one month, both reached this level)
Sign the informed consent form.
Exclusion Criteria:
Patient is known to be allergic or unsuitable for the Chinese herbal compound.
Women who are pregnant and lactating.
Patients had been menopause for more than 1 year.
Abnormal uterine bleeding, except ovulation disorders.
Women is taking hormone drugs and has stopped taking them within 3 months;
Women with endometriosis, myadenosis, submucosal fibroids or the size of non- submucosal fibroids is more than 4 cm.
The nature of pelvic mass is unknown.
Women with polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, diabetes, thyroid and adrenal dysfunction and other endocrine diseases affecting ovulation.
Patients with serious primary diseases such as cardiovascular, liver, kidney, lung, biliary, hematopoietic system (Hb<90g/L) and malignant tumor, and psychiatric patients.
Patients are participating in other clinical trials or have participated in other clinical trials within the last month.
Unsuitable for the study evaluated by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shixuan Wang, Professor
Phone
+8613995553319
Email
shixuanwang@tjh.tjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shixuan Wang, Professor
Organizational Affiliation
Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shixuan Wang, Professor
Phone
+8613995553319
Email
shixuanwang@tjh.tjmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of Chinese Herbal Compound TJAOA101 in the Treatment of Premature Ovarian Insufficiency
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