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Clinical Trials/CTRI/2024/03/064691
CTRI/2024/03/064691
Not yet recruiting
Phase 2/3

A randomized controlled clinical trial to evaluate the efficacy of Patoladi siddha taila pichu in comparison with Lidocaine 2% jelly local application in the management of Parikartika (Fissure-in-ano)

Dr Sanjay Kumar Srivastava1 site in 1 country60 target enrollmentStarted: April 19, 2024Last updated:

Overview

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Dr Sanjay Kumar Srivastava
Enrollment
60
Locations
1
Primary Endpoint
To assess the efficacy of Patoladi siddha taila pichu in management of pain in parikartika

Overview

Brief Summary

A randomized controlled clinical trial to evaluate the efficacy of Patoladi Siddha Taila Pichu in comparison with Lidocaine 2% jelly local application in the management of Parikartika ( Fissure - in - Ano). To study the efficacy of patoladi siddh taila in management of parikartika and also to study the adverse effect of patoladi siddha taila . The local application of patoladi siddha taila will be done for 15 days and assesment will be done before treatment and on 5th ,10th and 15th day. Final conclusion will be drawn on the basis of statistical data.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients having any 3 of following sign and symptoms Longitudinal Ulcer in anal region with pain during and defecation, Bleeding per rectum, constipation, anal burning sensation, increased anal spasm.

Exclusion Criteria

  • Patient on Anticoagulant Drug Patient with severe anaemia, crohns disease and ulcerative colitis.

Outcomes

Primary Outcomes

To assess the efficacy of Patoladi siddha taila pichu in management of pain in parikartika

Time Frame: To assess the efficacy of Patoladi siddha taila pichu in management of pain in parikartika in 15 days

Secondary Outcomes

  • To assess the efficacy of patoladi siddha taila pichu in management of wound healing process & management of raktasthambhak process & adverse effect in parikartika(To assess the efficacy of patoladi siddha taila pichu in the management of wound healing process & management of raktasthambhak process & adverse effect in parikartika in 15 days)

Investigators

Sponsor
Dr Sanjay Kumar Srivastava
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Sanjay Kumar Srivastava

Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18

Study Sites (1)

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