Based on the strategy of metabolomics, the key techniques of diagnosis of ovarian hypofunction and efficacy evaluation of kidney-tonifying method were studied

Not Applicable

• Conditions: Ovarian Dysfunction Premature Ovarian Failure

• Registration Number: ITMCTR1900002861
• Lead Sponsor: Jiangsu Province Hospital on Integration of Chinese and Western Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

normal group
1. Aged 21-49, female;
2. Menstrual color quantity and quality are normal;
3. No serious damage to the heart, liver, kidney or hematopoietic system;
4. Informed consent and voluntary participation.
Abnormal group
1. Western medicine meets the diagnosis criteria of ovarian hypofunction and premature ovarian failure, while traditional Chinese medicine meets the diagnosis criteria of kidney-yang deficiency or kidney-yin deficiency.
2. No serious damage to the heart, liver, kidney or hematopoietic system;
3. Informed consent and voluntary participation.

Exclusion Criteria

normal group
1. Menstrual color quantity and quality were normal after drug treatment;
2. Patients with obvious heart, brain, blood, neuropsychosis, endometrial cancer, ovarian cancer and other gynecological malignant tumors;
3. Pregnancy or lactation;
4. Drink or use drugs;
5. Other treatments received within 4 weeks.
Abnormal group
1. Congenital abnormal development of reproductive organs, or amenorrhea caused by acquired organic lesions and injuries;
2. Pregnancy or lactation;
3. Patients with obvious heart, brain, blood, neuropsychosis and diabetes;
4. Drink or use drugs;
5. Allergic to the research drugs;
6. Patients with polycystic ovary syndrome;
7. Patients receiving other treatment within 4 weeks.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gynecological B ultrasonic;Serum E2, FSH, LH and AMH levels;Changes in blood metabolomics;

Secondary Outcome Measures

Name	Time	Method
changes in TCM symptom score;blood routine;Stool routine;urine routine;renal function;Liver function;electrocardiography (ECG);Blood and urine HCG;