Efficacy and safety of traditional Chinese medicine external washing in the treatment of postoperative wound of diabetes complicated with anal fistula: study protocol of a randomized, double-blind, placebo-controlled, multi-center clinical trial.
- Conditions
- postoperative wound of diabetes complicated with anal fistula
- Registration Number
- ITMCTR2200005790
- Lead Sponsor
- Hospital of Chengdu University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Confirmed diabetes mellitus with postoperative anal fistula.
The diagnostic criteria for anal fistula will refer to the Guidelines for Clinical Diagnosis and Treatment of Anal Fistula (2006 Edition) jointly formulated by the Colorectal and Anal Surgery Group of Chinese Society of Surgery, Anorectal Branch of Chinese Society of Traditional Chinese Medicine and Specialized Committee of Colorectal and Anal Diseases, Chinese Association of Modern Medicine.
2. Aged 18 to 75.
3. 4cm2 = Postoperative wound area<30cm2.
4. TCM syndrome differentiation is dampness-heat blood stasis syndromereferring to the People's Republic of China Industry Standard for Traditional Chinese Medicine Diagnosis and Efficacy Criteria for Anal Leakage Syndrome.
5. No previous surgery for anorectal disease, no abnormal anal morphology or function.
6. Voluntary participation and signed informed consent.
1. Patients with severe diseases in important organs, including abnormal liver function, renal failure, heart failure, stroke, malignant tumors, etc.
2. Participated in other clinical trials within 3 months before enrollment.
3. Allergic to known drugs or experimental drugs.
4. Pregnant and lactating women.
5. Obvious mental disorders.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method inflammatory mediator levels;blood glucose;wound pathogen distribution;wound healing;
- Secondary Outcome Measures
Name Time Method blood lipid;SF-36;