Clinical Efficacy Analysis of Resveratrol in the Treatment of Primary Ovarian Insufficiency
1 other identifier
interventional
150
1 country
1
Brief Summary
Resveratrol is a natural plant antitoxin widely found in grapes, mulberries, and other plants. Resveratrol mediates a variety of pharmacological effects, including antioxidant, immunomodulatory, anti-inflammatory, and anti-apoptotic, and plays a protective and therapeutic role in the development of several ROS-related diseases, including POI/POF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
February 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 16, 2022
CompletedFirst Posted
Study publicly available on registry
June 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedJune 8, 2022
February 1, 2022
2.5 years
May 16, 2022
June 6, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Follicle-stimulating hormone (FSH)
Compare Differences
Third day of menstruation
Luteinizing hormone (LH)
Compare Differences
Third day of menstruation
Secondary Outcomes (3)
Anti-Mullerian hormone (AMH)
Third day of menstruation
Estradiol hormone (E2)
Third day of menstruation
Testosterone (T)
Third day of menstruation
Study Arms (2)
Patients who taking Resveratrol
EXPERIMENTALTake RES (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months
Patients who taking VitE
ACTIVE COMPARATORTake vitamin E at a dose of 100 mg per day for three months
Interventions
Take Resveratrol (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months
Take vitamin E at a dose of 100 mg per day for three months
Eligibility Criteria
You may qualify if:
- Amenorrhea or oligomenorrhea at least 4 months and two (\>4 weeks interval) basal FSH≥10mIU/ml；
- The women aged \<40 years old；
- Informed consent, voluntary experiment.
You may not qualify if:
- Pregnant and lactating patients;
- Patients with endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps, etc.), uterine fibroids\>4 cm or hysterectomy;
- Patients with adrenal cortical hyperplasia or tumour；
- Ovarian neoplasms patients；
- Hydrosalpinx patients；
- Hyperprolactinemia patients；
- Patients who are participating in other clinical trials or have participated in other clinical trials within the past three months;
- Patients with a suspected or real history of alcohol and drug abuse;
- Known allergy to the investigational drug or its components;
- Other patients were deemed unsuitable for participation in this trial by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
B ultrasound
Nantong, Jiangsu, 226000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
wang xia, Master
Hospital affiliated of nantong university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2022
First Posted
June 8, 2022
Study Start
February 1, 2022
Primary Completion
July 31, 2024
Study Completion
July 31, 2024
Last Updated
June 8, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share