Compound Phellodendron Decoction May Promote Wound Healing After Anal Fistulotomy (CPD)

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Fistula in Ano

Treatments: Combination Product: Fumigating-washing Therapy With CPD; Combination Product: fumigating-washing therapy with a placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06663527

2022-zj-19

2023AH050848 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Study Group

Experimental group

Description:

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

Treatment:

Combination Product: Fumigating-washing Therapy With CPD

Control Group

Placebo Comparator group

Description:

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

Treatment:

Combination Product: fumigating-washing therapy with a placebo