Clinical trial NCT06332742: Real-world Evaluation of Qingxin Zishen Decoction on Ovarian Reserve Function Clinical Efficacy in Patients With Decreased
Official title: Real-world Evaluation of the Clinical Efficacy of Qingxin Zishen Decoction in Patients With Reduced Ovarian Reserve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Decreased Ovarian Reserve
Lead sponsor: Jiangsu Province Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 178
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Those who meet the diagnostic criteria for hypoovarian reserve disease and the TCM syndrome differentiation criteria for heart and kidney disharmony.
2. Aged between 25 and 45 years old, female.
3. Informed consent and voluntary participation.
4. The process of obtaining informed consent should comply with GCP regulations.

Brief summary: A prospective cohort study evaluated the clinical efficacy of Qingxin Zishen Decoction


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.

1. Those with reduced ovarian function caused by ovarian or uterine surgery, radiotherapy and chemotherapy;
2. Liver function (AST or ALT) and renal function (BUN or Ccr) are greater than 2 times the normal value;
3. Patients with a history of mental illness or legal disability
4. 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.
5. Patients with unexplained irregular vaginal bleeding
6. Patients who are participating in clinical trials of other drugs
7. For women who want to have children, those whose spouse's semen test fails to meet the standard will be excluded.

Primary outcomes:
measure: Traditional Chinese medicine syndrome score
timeFrame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
measure: serum sex hormone levels
timeFrame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
measure: serum AMH levels
timeFrame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
measure: transluminal ultrasound evaluation of ovarian antral follicles and other parameters (AFC)
timeFrame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
Secondary outcomes:
measure: Seven items of thyroid function
timeFrame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
measure: natural pregnancy rate
timeFrame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
state: Jiangsu
Study officials:
References: