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

Decreased Ovarian Reserve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06332742
• Other study ID #: QXZS for DOR
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Jiangsu Province Hospital of Traditional Chinese Medicine
• Contact: Chen Yun
• Phone: 8613675167221
• Email: 66teoyq[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Decreased Ovarian Reserve

Locations

Country	Name	City	State
China	Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yun Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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