Compound Phellodendron Decoction May Promote Wound Healing After Anal Fistulotomy

NCT06663527 | Completed

• 2 other identifiers: 2022-zj-192023AH050848
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fistula in Ano

Keywords

Anal fistula

Outcome Measures

Primary Outcomes (1)

• The healing duration of wounds

  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.

Study Arms (2)

Study Group

EXPERIMENTAL

Study group (n=30) treated fumigating-washing therapy with the CPD

Combination Product: Fumigating-washing Therapy With CPD

Control Group

PLACEBO COMPARATOR

Control group (n=30) underwent fumigating-washing therapy with a placebo

Combination Product: fumigating-washing therapy with a placebo

Interventions

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).

Study Group

fumigating-washing therapy with a placebo COMBINATION_PRODUCT

fumigating-washing therapy with a placebo

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine: lead

Study Sites (1)

Anhui university of Chinese Medicine

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Second Affiliated Hospital of Anhui University of Chinese Medicine

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: October 26, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 12, 2025

Record last verified: 2024-10

Locations

CN (1)