A prospective, multicenter, controlled, real-world clinical study of Tiaoshen Xuanluo Changmo formula combined with abdominal external application to improve endometrial blood flow after TCRA

Not Applicable

• Conditions: Intrauterine adhesion after TCRA of Kidney deficiency and blood stasis type

• Registration Number: ITMCTR2200006497
• Lead Sponsor: Yunnan Provincial Hospital of Traditional Chinese 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

1) Married female, aged 20-40 (including 20 and 40);
2) Body mass index (BMI) 18-26 (kg/m2) (including boundary value);
3) Meet the diagnostic criteria of Western medicine IUA and traditional Chinese medicine kidney deficiency and blood stasis syndrome;
4) After TCRA;
5) Good compliance, willing to participate in and cooperate with researchers to complete the study;
6) The nature, significance, possible benefits, possible inconvenience and potential risks and discomfort of the trial have been understood in detail before the trial, and they have voluntarily participated in the clinical trial and signed a written informed consent.

Exclusion Criteria

1) Those who do not meet the above diagnostic criteria;
2) Those aged <20 years or >40 years;
3) Body mass index (BMI) < 18 or > 26 (kg/m2);
4) Adhesion of cervical canal;
5) Menorrhagia caused by other diseases;
6) Congenital malformation of reproductive organs (such as uterine mediastinum, residual horn uterus, etc.);
7) Organic diseases of reproductive system (such as tuberculosis of reproductive system);
8) Patients with serious cardiovascular, cerebrovascular, liver, kidney and other major organ diseases;
9) Those who have taken hormone or similar traditional Chinese medicine treatment 1 month (30 days) before administration;
10) Those who are known to be allergic to the study drug (including the excipients of the study drug) or its analogues, or those with allergic constitution (such as those who are allergic to two or more drugs, food and pollen).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
TCM clinical symptom score;

Secondary Outcome Measures

Name	Time	Method
Endometrial blood flow parameters(PI\RI\S/D);Endometrial thickness;