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Real-world Evaluation of Qingxin Zishen Decoction on Ovarian Reserve Function Clinical Efficacy in Patients With Decreased

Y

Yun Chen

Status

Enrolling

Conditions

Decreased Ovarian Reserve

Study type

Observational

Funder types

Other

Identifiers

NCT06332742
QXZS for DOR

Details and patient eligibility

About

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

Enrollment

178 estimated patients

Sex

Female

Ages

25 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

178 participants in 2 patient groups

Exposome group
Description:
5g lotus seed heart, 3g coptis, 15g uncaria, 15g fried jujube kernel, 10g dried rehmannia glutinosa, 9g dogwood meat, 10g salvia miltiorrhiza, 30g floating wheat. 1 dose per day, decocted in water twice, 200ml each time, taken warmly after breakfast and dinner
Non-exposed group
Description:
All patients who met the inclusion criteria and did not use Qingxin Zishen Decoction.

Trial contacts and locations

1

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Central trial contact

Chen Yun; TEO YONG QING

Data sourced from clinicaltrials.gov

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