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

Real-world Evaluation of the Clinical Efficacy of Qingxin Zishen Decoction in Patients With Reduced Ovarian Reserve

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

Study Overview

• Status: Recruiting
• Conditions: Decreased Ovarian Reserve

• Study Type: Observational
• Enrollment (Estimated): 178

Contacts and Locations

• Study Contact: Name: Chen Yun; Phone Number: 8613675167221; Email: 66teoyq@gmail.com
• Study Contact Backup: Name: TEO YONG QING; Phone Number: 8613809008363; Email: 66teoyq@gmail.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210023
      • Recruiting
      • Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
      • Contact: Chen Yun; Phone Number: 8613675167221; Email: 66teoyq@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Exposome group; 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; All patients who met the inclusion criteria and did not use Qingxin Zishen Decoction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Traditional Chinese medicine syndrome score	Traditional Chinese medicine syndrome score	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	SHBG stands for sex hormone binding globulin. It's a protein made mostly in your liver. It binds (attaches) to sex hormones in your blood.	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	An AMH test measures levels of anti-mullerian hormone, which corresponds to a person's egg count.	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)	Antral follicle count is rightly done on day 3 of the cycle by a Trans vaginal ultrasound. Initially the ovarian volume of both the ovaries is calculated.	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

Outcome Measure	Measure Description	Time Frame
Seven items of thyroid function	The thyroid gland produces hormones that regulate the body's metabolic rate, growth and development. It plays a role in controlling heart, muscle and digestive function, brain development and bone maintenance.	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	A woman in her early to mid-20s has a 25-30% chance of getting pregnant every month. Fertility generally starts to slowly decline when a woman is in her early 30s, and after the age of 35 the decline speeds up. By age 40, the chance of getting pregnant in any monthly cycle is around 5%.	Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment

Collaborators and Investigators

• Sponsor: Yun Chen

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 3, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: QXZS for DOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No