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A Clinical trial in siddha for fistula with Panchapadana Chenduram and Meni thylam

Phase 4
Completed
Conditions
Anal fistula,
Registration Number
CTRI/2024/01/061252
Brief Summary

Fistula in ano is a common surgical anorectal anomaly; it is notorious due to its chronicity,recurrences, and frequent exacerbations. A study conducted among the Indian rural population

estimated the incidence of low anal fistula around 8.6 per 1 lakh population with male to female ratio as 11.2:1.The disease ischaracterized by one or more external openings in the perianal region with an apparent internal opening anywhere in the anorectal mucosa. Pus discharge associated with mild to severe pain will be thepresenting feature.The goals in the treatment of an anal fistula are to eliminate the primary fistula opening,any associated tracts, or any secondary openings without a change in continence.

The simplest analfistulae are treated using fistulotomy with a high rate of recurrences and other morbidities. Complexfistulae management poses increased risk of a change in continence and higher chances of recurrenceswhich forced the surgeons to search for a better option.Various modalities like cutting seton,advancement flap, fibrin glue injection, fistula plug,ligationofintersphincteric fistula tract (LIFT), orBioLIFT (LIFT technique with a variation) are being tried to overcome the hardship faced by the

patients.Hence this pilot study is put forward to assess the therapeutic efficacy of Pancha paadanachendooram and Meni thylam which are indicated for Powthiram (Fistula in ano) condition as perclassical Siddha Literature in management of fistula in ano.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
10
Inclusion Criteria
  • Patient who will fulfil following criteria will be included in this study: 2.
  • Age: 18 to 60 years.
  • Patients diagnosed with the condition of low anal fistula having single tract of length not more than 8 cm 4.
  • Fistula patients of less than 3 years duration 5.
  • Willingness of the patient to give blood and urine samples and cooperate by strictly complying with the medical advice of the research team.
  • Patients who had not undergone previous surgery for fistula.
Exclusion Criteria
  • H/o Tuberculosis ï‚·Uncontrolled metabolic disorders ï‚· H/o Hepatitis B & C.
  • ï‚· H/o Haemophilia and bleeding disorders.
  • ï‚· H/o Pregnancy & Lactation.
  • ï‚· H/o Uncontrolled diabetes ï‚· H/o coronary heart diseases and other cardiac ailments.
  • ï‚· H/o AIDS, Syphilis.
  • ï‚· H/o Crohn’s disease.
  • ï‚· High anal fistula and complicated fistula ï‚· H/o Rectal prolapse ï‚· H/o rectal carcinoma.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Number of patients achieved a Zero score of Peri Anal Disease Activity90 days
Index (PDAI).90 days
Secondary Outcome Measures
NameTimeMethod
Duration taken for healing will be analyzed and described with respectto the length of the tract and duration of the condition prior to the

Trial Locations

Locations (1)

Ayothidoss Pandithar Hospital

🇮🇳

Chennai, TAMIL NADU, India

Ayothidoss Pandithar Hospital
🇮🇳Chennai, TAMIL NADU, India
DRGJCHRISTIAN
Principal investigator
9962545930
christianvijila@gmail.com

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