A clinical study to compare the results of Shaivaladya Ghrita and Yashtimadhu Ghrita in the patients suffuring from Acute Fissure in Ano (A tear in anal canal)

Phase 2

Not yet recruiting

• Conditions: Other specified diseases of the digestive system,

• Registration Number: CTRI/2020/04/024531
• Lead Sponsor: Parul institute of ayurveda

Brief Summary

1. Parikartika(Fissure-in-ano) is the commonest anorectal condition seen in the day-to-day practice. Recent statistics reveals that more than 80% of population suffers from this disease. In this condition the Constipation and Mandagni are the prime causative factors

2.Acharya Dalhana has described the parikartika as a condition in which there is cutting and tearing pain in Guda. The factors responsible for causation of Parikartika as found in various texts are Vamana-Virechana-Vyapada, Bastikarma Vyapada, Atisara, Grahani, Arsha, Udavarta etc.

3.The common causes for Fissure-in-Ano are trauma to the anal canal due to hard stool and spasm of internal sphincter. The disease is also secondary to systemic conditions like ulcerative colitis, Crohn’s disease, tuberculosis, etc. The disease also manifests as a delayed complication of surgical procedures like Haemorrhoidectomy and Fistulectomy.

4. In present modern science many treatment modalities are available, but all are temporarily effective, and with less or more side effects.

5.So the Shaivaladya Ghrita is selected for the clinical trial in the management of Parikartika (Acute fissure-in-Ano) to find fast, soothing, long term and fruitful remedy.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-17
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients suffering from Parikartika (Acute fissure-in-ano) with symptoms of Painful defecation, burning sensation, bleeding per rectum i.e. stools streaked with blood, constipation, spasm of the sphincter.
• Patient having solitary and multiple anal fissures.
• Pregnant women and Post partum patients.
• Patient within the age group of 18 to 70 years of age.
• Patients will be selected irrespective of cast and religion, gender, habitat, occupation and socio- economic status.

Exclusion Criteria

• Chronic fissure-in-ano.
• Patients having parikartika (Fissure-in-Ano) secondary to known case of Ulcerative colitis, Crohn’s disease, Syphilis and Tuberculosis, Malignancy will be excluded.
• Patient below 18 years of age.
• Patient with infective wound at anal region.
• HIV and hepatitis B.
• Uncontrolled diabetes mellitus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shaivaladya Ghrita will be more effective than Yashtimadhu Ghrita in the management of parikartika in 10 days in Indian Population	Shaivaladya Ghrita will be more effective than Yashtimadhu Ghrita in the management of parikartika in 10 Days in Indian Population

Secondary Outcome Measures

Name	Time	Method
nill	nill

Trial Locations

Locations (1)

Parul ayurved hospital; 🇮🇳 Vadodara, GUJARAT, India

Parul ayurved hospital

🇮🇳Vadodara, GUJARAT, India

Dr shubham khare

Principal investigator

9424422043

skhare1112@gmail.com