kaathiri for pauthiram(fistula in ano)

Phase 3

Completed

• Conditions: Anal fistula,

• Registration Number: CTRI/2022/07/044467
• Lead Sponsor: National institute of Siddha

Brief Summary

It is an open, non - randomized, single arm, single centric trial to determine the therapeutic efficacy of kaarathiri in the management of pauthiram (Fistula in ano)recurrent anal abscess, pain and swelling around the anus, pain with bowel movements, bloody or foul-smelling drainage (pus) from an opening around the anus will be enrolled based on the inclusion and exclusion criteria. After enrolling the patients in the study, the treatment will be given with kaarathiri- 3 months 2 days once. After the 3 months the reduction in symptoms will be assessed by Perianal Disease Activity Index (PDAI).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-08
• Study Completion: 2023-08-20
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age: 18 to 60 years.
• Patients having the clinical features of the following Pus and or blood discharge, discharge from perianal and anal region.
• Sex: Male, Female and Transgender.
• Fistula tract within 4 cm.
• Patient who are willing to undergo Kaarathiri therapy.
• Willing to give specimen of blood for investigation whenever required.
• Willing to attend OPD or admission in IPD for 3 months.
• Willing to take photograph before and after treatment Patient willing to take MRI.

Exclusion Criteria

• Tuberculosis (Genito urinary tract).
• Hepatitis B & C.
• H/o Haemophilia and bleeding disorders.
• Pregnancy & Lactation.
• Uncontrolled diabetes H/o Coronary Heart Diseases and other cardiac ailments.
• AIDS, Syphilis.
• H/o Crohn’s disease.
• High anal fistula and complicated fistula Rectal prolapse H/o rectal carcinoma.
• Not willing to take Investigations..

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
outcome of the study will be measured by Reduction in pain, pus discharge, burning sensation, itching around the anus well be accessed by Perianal Disease Activity Index (PDAI).	90 days

Trial Locations

Locations (1)

Ayothidoss Pandithar Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Ayothidoss Pandithar Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr Ramya V

Principal investigator

7708604896

ramyapadma3697@gmail.com