An interventional study of Fumigating-washing Therapy With CPD and fumigating-washing therapy with a placebo in Fistula in Ano, sponsored by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
Sitz-bath therapy with Chinese medicine has significant advantages in the management of postoperative wounds of anal fistula. This method not only ensures safety, efficacy, and cost-effectiveness, but also simplifies application. With a firm foundation in a historical heritage, this method is notable for their minimal adverse reactions. The fumigating-washing or sitz-bath therapy with Compound Phellodendron Decoction (CPD) for postoperative wounds of anal fistula has demonstrated efficacy in mitigating pain, reducing edema, curbing secretions, alleviating skin itching, and promoting wound healing processes. Despite the body of clinical research in this domain is substantial, the majority of studies have been limited to observing therapeutic outcomes. The intrinsic mechanisms by which these effects are achieved remain elusive. This study aims to unravel the potential mechanisms underpinning CPD's promotion of wound healing, focusing on the aspects of inflammation and immunity.
169 studies on the registry are indexed under Rectal Fistula; 45 are open to participants now.
This study's enrollment of 60 is close to the median of 66 across 115 interventional studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Inclusion Criteria:age range of 18 to 80 years who had undergone anal fistulotomy procedures.
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Exclusion Criteria:patients with Crohn's disease, pregnancy or lactation, organ dysfunction (such as heart failure, respiratory insufficiency, liver or renal impairment, gastrointestinal dysfunction), coagulopathy, diseases, or a history of to Chinese medicinal substances.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study group (n=30) treated fumigating-washing therapy with the CPD
Combination Product: Fumigating-washing Therapy With CPD
Control group (n=30) underwent fumigating-washing therapy with a placebo
Combination Product: fumigating-washing therapy with a placebo
All patients underwent anal fistulectomy based on the Parks classification. For postoperative infection prophylaxis, cefuroxime was used at a dosage of 2g per dose, twice daily. Commencing the day following surgery, a fumigating-washing therapy was conducted once daily either after defecation or two hours prior to intravenous infusion. In the study group, a medical solution used for fumigating-washing therapy was prepared by blending 200 ml of CPD with 2 liters of water at 40 °C. This medicinal solution was then transferred into the reservoir of an ultrasonic atomizing fumigating-washing device (Model:TM50-C, Xuzhou Tianma Medical Equipment Factory, China) that was classified by the FDA as Class II (special controls).
fumigating-washing therapy with a placebo
The healing duration of wounds
The healing duration of wounds, edema, exudation, and pain scores, served as the principal observation index.
Time frame: The healing duration of wounds, edema, exudation, and pain scores, served as the principal observation index.
Plan to share: Undecided
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine