Effect of panchavalkala kera thailam as anal instillation in acute fissure in ano

Phase 2

Not yet recruiting

• Conditions: Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA,

• Registration Number: CTRI/2025/05/087555

Brief Summary

A CLINICAL STUDY TO EVALUATE THE EFFECT OF PANCHAVALKALA  KERATHAILA IN   ACUTE FISSURE IN ANO

Fissure in Ano is an elongated ulcer in long axis of lower anal canal. In acute fissure, there will be spasm of anal sphincter muscle, pain on defecation, and passage of bright streaks of blood after passing stool. The signs and symptoms  of fissure in ano can be compared  with parikartika as per Ayurveda. Management of this condition includes vatanulomana, shoolahara and vranaropana measures. The drug of choice in present study is Panchavalkala  which is mentioned in Bhavaprakasa Nighantu. The aim of the study is to assess effect of anal instillation with panchavalkala kerathailam in Acute fissure in Ano.  This will be a single arm pre test and post test clinical trial. 31 participants diagnosed with acute fissure in ano within age group of 18 to 50 years satisfying inclusion and exclusion criteria will be selected from Pankaja Kasthuri Ayurveda Medical college hospital. The selected participants will be managed by anal instillation with Panchavalkala kerathaila for 7days. Assessment of ulcer in ano, pain and bleeding from fissure is done on before treatment, 8th day, and follow up on 15th and 22nd day. The data collected will be analyzed statistically using approppriate statistical techniques

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-24
• Study Start: 2025-06-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Subjects within age group of 18 to 50 years Subjects recruited irrespective of gender fulfilling diagnostic criteria of acute Fissure in ano mentioned above Subjects willing to sign consent form.

Exclusion Criteria

Fissure in ano secondary to diseases like Crohns disease Tuberculosis Syphilis Ulcerative colitis malignancy etc Subjects with known case of carcinoma of rectum Subjects with uncontrolled Diabetes Mellitus and Hypertension Pregnant ladies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of anal instillation with Panchavalkala Kerataila in acute Fissure in ano	To assess the effect of anal instillation with Panchavalkala Kerataila in acute Fissure in ano | Assessment of ulcer in ano, pain, bleeding from fissure at baseline, 8th day and follow up on 15th and 22nd day.
To evaluate the effect of anal instillation with Panchavalkala Kerataila in acute Fissure-in-ano	To assess the effect of anal instillation with Panchavalkala Kerataila in acute Fissure in ano | Assessment of ulcer in ano, pain, bleeding from fissure at baseline, 8th day and follow up on 15th and 22nd day.
Assessment of ulcer in ano, pain, bleeding from fissure at baseline, 8th day and follow up on 15th and 22nd day.	To assess the effect of anal instillation with Panchavalkala Kerataila in acute Fissure in ano | Assessment of ulcer in ano, pain, bleeding from fissure at baseline, 8th day and follow up on 15th and 22nd day.

Trial Locations

Locations (1)

Pankajakasthuri Ayurveda Medical College and Post Graduate Centre; 🇮🇳 Thiruvananthapuram, KERALA, India

Pankajakasthuri Ayurveda Medical College and Post Graduate Centre

🇮🇳Thiruvananthapuram, KERALA, India

Dr Athira Mohan T

Principal investigator

8592811353

athiramthiruthoor@gmail.com