Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
Nanjing, Jiangsu, 210023, China
Location status: Recruiting
Recruiting
NCT Number: NCT06332742
Real-world Evaluation of Qingxin Zishen Decoction on Ovarian Reserve Function Clinical Efficacy in Patients With Decreased
A prospective cohort study evaluated the clinical efficacy of Qingxin Zishen Decoction
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
25 year–45 year
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
- Those with reduced ovarian function caused by ovarian or uterine surgery, radiotherapy and chemotherapy;
- Liver function (AST or ALT) and renal function (BUN or Ccr) are greater than 2 times the normal value;
- Patients with a history of mental illness or legal disability
- 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.
- Patients with unexplained irregular vaginal bleeding
- Patients who are participating in clinical trials of other drugs
- For women who want to have children, those whose spouse's semen test fails to meet the standard will be excluded.
Treatment and study plan
Primary outcomes
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Traditional Chinese medicine syndrome score
Time frame: 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
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serum sex hormone levels
Time frame: 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.
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serum AMH levels
Time frame: 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.
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transluminal ultrasound evaluation of ovarian antral follicles and other parameters (AFC)
Time frame: 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.
Secondary outcomes
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Seven items of thyroid function
Time frame: 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.
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natural pregnancy rate
Time frame: 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%.
Study contacts
Contact information is provided by the study sponsor or research team.
Chen Yun
CONTACT
TEO YONG QING
CONTACT
Sponsors and collaborators
Lead sponsor
Yun Chen
Other
Registry information
Official study title
Real-world Evaluation of the Clinical Efficacy of Qingxin Zishen Decoction in Patients With Reduced Ovarian Reserve
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Mar 27, 2024
- Registry last updated
- Apr 4, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.