Prospective, multicenter, controlled, real-world clinical study on acupoint application combined with traditional Chinese medicine in the treatment of thin endometrium of kidney deficiency and blood stasis type before habitual abortion pregnancy
- Conditions
- thin endometrium of kidney deficiency and blood stasis type before habitual abortion pregnancy
- Registration Number
- ITMCTR2200006496
- Lead Sponsor
- Yunnan Provincial Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
1. Married female, 20 years old = age = 40 years old;
2. Body mass index (BMI) 18-26 (kg/m2) (including boundary value);
3. It meets the diagnostic criteria of recurrent abortion and follicular dysplasia in western medicine and the diagnostic criteria of spleen and kidney deficiency in traditional Chinese medicine;
4. Good compliance, willing to participate in and cooperate with researchers to complete the study;
5. 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.
1. Those who do not meet the above diagnostic criteria;
2. Age <24 years old or > 40 years old;
3. Body mass index (BMI) < 18 or > 26 (kg/m2);
4. Congenital malformations or organic diseases of reproductive organs, such as uterine mediastinum, residual horn uterus, ovarian cyst, etc., which affect follicular development and ovulation;
5. Hypothalamic and pituitary factors affect follicular development and ovulation;
6. Ovarian tissue damage caused by malignant tumors, radiation, surgery or inflammation damage to the ovary, affecting follicular development and ovulation;
7. Have serious cardiovascular, liver, kidney and systemic diseases;
8. Vague consciousness and unable to accurately express discomfort symptoms;
9. 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);
10. Patients with sensitive skin, skin allergy, acute / chronic urticaria and other skin diseases.
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 thickness;Endometrial typing;Endometrial blood flow parameters (uterine artery PI, RI, s/d);