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

NCT06332742 | Recruiting

• 1 other identifier: QXZS for DOR
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Decreased Ovarian Reserve

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 25 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yun Chen: lead

Study Sites (1)

Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine

Nanjing, Jiangsu, 210023, China

RECRUITING

Central Study Contacts

Chen Yun

CONTACT

8613675167221; 66teoyq@gmail.com

TEO YONG QING

CONTACT

8613809008363; 66teoyq@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 27, 2024
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)