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

Recruiting

• Conditions: Decreased Ovarian Reserve

• Registration Number: NCT06332742
• Lead Sponsor: Yun Chen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2024-03-03
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 178

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Traditional Chinese medicine syndrome score
serum sex hormone levels	Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment	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.
transluminal ultrasound evaluation of ovarian antral follicles and other parameters (AFC)	Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment	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.
serum AMH levels	Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment	An AMH test measures levels of anti-mullerian hormone, which corresponds to a person's egg count.

Secondary Outcome Measures

Name	Time	Method
Seven items of thyroid function	Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment	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.
natural pregnancy rate	Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment	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%.

Trial Locations

Locations (1)

Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine; 🇨🇳 Nanjing, Jiangsu, China