Comparative study of Karanjadi Ghruta, Yasthimadhu Ghruta and Jatyadi Ghruta local application in the Management of Fissure in ano

Phase 3

Not yet recruiting

• Conditions: Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA, (2) ICD-10 Condition: K929||Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA,

• Registration Number: CTRI/2023/02/049706
• Lead Sponsor: Mahatma gandhi ayurved college hospital and research center

Brief Summary

The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per comport generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done.After selection, each participant will be tested individually and selected according to selection criteria. They are divided into three groups.

The trial is a parallel-group, randomized, single-blind, standard - controlled trial. It will include, a 21 days treatment period, and a 7th, 14th & 21th day week follow-up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-16
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Parikartika (Acute Fissure in Ano) patients who clinically diagnosed / confirmed by inspection.
• 2.Patients’ age- between 18 and 60 years in either sex.
• 3.Fissure-in-Ano patients of with controlled systemic diseases like Diabetes; and Hypertension 4.Willing full to participate and able to complete the study period.

Exclusion Criteria

• 1.Parikartika (Fissure in Ano) present with secondary condition as Ulcerative colitis, Chron’s disease, Syphilis and Tuberculosis.
• Patients with systemic disease like Diabete and Hypertension which is uncontrolled.
• 3.Patients with HIV and HbsAg positive.
• 4.Any condition which may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess efficacy of Karanjadi Ghruta Pichu in the Management of Parikartika in total effect of healing, pain, spasm & bleeding after 3 weeks of treatment	To assess efficacy of Karanjadi Ghruta Pichu in the Management of Parikartika in total effect of healing, pain, spasm & bleeding after 3 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
To assess efficacy of Karanjadi Ghruta Pichu in the Management of Parikartika in total effect of healing, pain, spasm & bleeding	before treatment

Trial Locations

Locations (1)

Mahatma gandhi ayurved college hospital and research center; 🇮🇳 Wardha, MAHARASHTRA, India

Mahatma gandhi ayurved college hospital and research center

🇮🇳Wardha, MAHARASHTRA, India

DR PRADEEP KUMAR PRADHAN

Principal investigator

9907930733

drpradhanpradeep25@gmail.com