Recruiting NCT06332742
Real-world Evaluation of Qingxin Zishen Decoction on Ovarian Reserve Function Clinical Efficacy in Patients With Decreased
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Decreased Ovarian Reserve. Basic parameters: 25 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-world Evaluation of the Clinical Efficacy of Qingxin Zishen Decoction in Patients With Reduced Ovarian Reserve
Overview
A prospective cohort study evaluated the clinical efficacy of Qingxin Zishen Decoction
Primary outcome measures
- Traditional Chinese medicine syndrome score [Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment]
- serum sex hormone levels [Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment]
- serum AMH levels [Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment]
- transluminal ultrasound evaluation of ovarian antral follicles and other parameters (AFC) [Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment]
Secondary outcome measures (2)
- Seven items of thyroid function [Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment]
- natural pregnancy rate [Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment]
Eligibility criteria
1.AMH AMH <1.1ng/ml 2.AFC: AFC <5\~7 ovaries on both sides 3.Basic FSH: Basal FSH for two consecutive menstrual cycles ≥10 IU/L 4.Aged between 25 and 45 years old, female.
- Those with reduced ovarian function caused by ovarian or uterine surgery, radiotherapy and chemotherapy;
- Liver function (AST or ALT) and renal function (BUN or Ccr) are greater than 2 times the normal value;
- Patients with a history of mental illness or legal disability
- Those who have used endocrine-affecting drugs within 3 months before the study, estrogen, progesterone or related compound preparations, oral contraceptive pills, Chinese medicines or Chinese patent medicines related to the treatment of premature ovarian failure. Our hospital's preparations include Wu Turtle Rejuvenation Oral Liquid and Kuntai Capsules.
- Patients with unexplained irregular vaginal bleeding
- Patients who are participating in clinical trials of other drugs
- For women who want to have children, those whose spouse's semen test fails to meet the standard will be excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing Universi — Nanjing
Identifiers
NCT: NCT06332742 · QXZS for DOR