Compound Phellodendron Decoction May Promote Wound Healing After Anal Fistulotomy

NCT ID: NCT06663527

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-26
• Study Completion Date: 2025-02-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study Group

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

Group Type: EXPERIMENTAL

Fumigating-washing Therapy With CPD

Intervention Type: 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).

Control Group

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

Group Type: PLACEBO_COMPARATOR

fumigating-washing therapy with a placebo

Intervention Type: COMBINATION_PRODUCT

fumigating-washing therapy with a placebo

Interventions

Fumigating-washing Therapy With CPD

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).

Intervention Type: COMBINATION_PRODUCT

fumigating-washing therapy with a placebo

fumigating-washing therapy with a placebo

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Heng Deng

The Second Affiliated Hospital of Anhui University of Chinese Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anhui university of Chinese Medicine

Hefei, Anhui, China

Countries

China

Other Identifiers

2023AH050848

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2022-zj-19

Identifier Type: -

Identifier Source: org_study_id