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FiILaC combing with QingRe-Lishi Recipe for treating complex anal fistula:A multi-centre randomized controlled clinical research

FiILaC combing with QingRe-Lishi Recipe for treating complex anal fistula:A multi-centre randomized controlled clinical research

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17012085
Enrollment
Unknown
Registered
2017-07-22
Start date
2017-08-01
Completion date
Unknown
Last updated
2017-07-24

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

Conditions

anal fistula

Interventions

treatment group:FiLaC combing with QingRe-Lishi Recipe
control group:anal fistulectomy+seton combing withQingRe-Lishi Recipe

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of T.C.M
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) imaging examination (nuclear magnetic resonance) in patients with complex II-IV type Parks complicated anal fistula; (2) the fistula was in stable phase and had not received any specialized instruments and surgical treatment in the past 3 months; (3) there was no operation contraindication; (4) TCM syndrome differentiation belongs to damp heat bet type; (5) Aged 18 years to 65 years old; (6) subjects without major organ dysfunction, blood routine, liver and kidney of normal cardiac function: hemoglobin is larger than 120g/L, the absolute neutrophil count (ANC) = 1.5 x 10^9/L = 80 * 10^9/, platelet L, bilirubin = 1.5ULN, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) is less than 2.5 * ULN. INR = 1.5, 1.5ULN = creatinine; (7) voluntarily joined the experiment and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) colonoscopy excluded other anorectal diseases or surgical patients (including colorectal cancer, Krohn's disease, ulcerative colitis, intestinal tuberculosis, etc.); (2) hematopoietic and coagulopathy; (3) the history of cardiovascular disease: congestive heart failure > NYHA, II in heart function. Patients with unstable angina pectoris (angina pectoris at rest) or new onset angina pectoris (which started in the past 3 months) or myocardial infarction occurred in the past 6 months. Active infection, grade >2 adverse events (CTC, AE.3.0). Preoperative blood pressure was over 160/90mmHg; (4) pregnant or lactating patients; menstrual patients; (5) suffering from a history of mental illness that is difficult to control.

Design outcomes

Primary

MeasureTime frame
curative ratio;

Secondary

MeasureTime frame
Duration of surgery;hemorrhage during surgery;Fecal incontinence severity index;Anorectal Manometry;wound healing time;visual analogue scale;

Countries

China

Contacts

Public ContactZhenyi Wang

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of T.C.M

drxinhuo@163.com+86 13601760317

Outcome results

None listed

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