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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06332742
Enrollment
178
Registered
2024-03-27
Start date
2023-11-01
Completion date
2026-12-31
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decreased Ovarian Reserve

Brief summary

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

Interventions

None listed

Sponsors

Yun Chen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
serum sex hormone levelsKeep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatmentSHBG stands for sex hormone binding globulin. It's a protein made mostly in your liver. It binds (attaches) to sex hormones in your blood.
Traditional Chinese medicine syndrome scoreKeep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatmentTraditional Chinese medicine syndrome score
serum AMH levelsKeep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatmentAn AMH test measures levels of anti-mullerian hormone, which corresponds to a person's egg count.
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 treatmentAntral 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

MeasureTime frameDescription
Seven items of thyroid functionKeep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatmentThe 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 rateKeep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatmentA 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%.

Countries

China

Contacts

Primary ContactChen Yun
66teoyq@gmail.com8613675167221
Backup ContactTEO YONG QING
66teoyq@gmail.com8613809008363

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026