Compound Phellodendron Decoction May Promote Wound Healing After Anal Fistulotomy

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.

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Key information

Conditions

Fistula in Ano Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anhui university of Chinese Medicine

Hefei, Anhui, 230000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age range of 18 to 80 years who had undergone anal fistulotomy procedures.

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, autoimmune diseases, or a history of hypersensitivity to Chinese medicinal substances.

Treatment and study plan

Fumigating-washing Therapy With CPD

Combination Product

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

Combination Product

fumigating-washing therapy with a placebo

Primary outcomes

The healing duration of wounds

Time frame: The healing duration of wounds, edema, exudation, and pain scores, served as the principal observation index.

The healing duration of wounds, edema, exudation, and pain scores, served as the principal observation index.

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Other

Registry information

Acronym: CPD

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 29, 2024
Registry last updated: Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed