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.

Multi-center clinical efficacy and mechanism study of external washing of traditional Chinese medicine on postoperative wound of diabetes complicated with anal fistula

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200005790

Enrollment

Unknown

Registered

2022-03-30

Start date

2022-05-01

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative wound of diabetes complicated with anal fistula

Interventions

Intervention group:traditional Chinese medicine external washing

Placebo group:placebo

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
inflammatory mediator levels;blood glucose;wound pathogen distribution;wound healing;	—

Secondary

Measure	Time frame
blood lipid;SF-36;	—

Countries

China

Contacts

Public ContactKang Jian

kangjian0181@cdutcm.edu.cn18908092665

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026