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Clinical Trials/CTRI/2024/06/068891
CTRI/2024/06/068891
Not yet recruiting
Phase 3 4

Clinical Comparative Study To Evaluate The Efficacy Of Local Application Of Trailokya Vijaya Gel And Lignocaine Gel In Postoperative Pain Management In Anorectal Surgeries

Post Graduate Institute Of Ayurved Jodhpur,Rajastan1 site in 1 country40 target enrollmentStarted: June 30, 2024Last updated:

Overview

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Post Graduate Institute Of Ayurved Jodhpur,Rajastan
Enrollment
40
Locations
1
Primary Endpoint
To establish the efficacy of Trailokya Vijaya gel compared to lignocaine gel to relieve pain after Anorectal Surgeries

Overview

Brief Summary

Number of patients: 40 (20 patients in each)

Study type: Interventional (clinical trial), Randomized comparative study

40 patients fulfilling the inclusion criteria are fit for the study, should be randomly selected:

Group A: Lignocaine Gel 2% in 20 patients.

Group B: Trailokya Vijaya Gel in 20 patients.

Duration of study: 2-4 weeks

Follow up: From 2nd week to 4th week after every 7 days.

Study Design

Study Type
Interventional
Allocation
Other
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1 Consented individuals 2 Either Sex, Age group between 20 and 99 years 3 Anorectal surgical procedures under local anaesthesia 4 Patients fulfilling diagnostic criteria.

Exclusion Criteria

  • 1 Subjects suffering from severe systemic diseases such as diabetes, hypertension, bronchial asthma, cardiac disease, renal failure, etc.
  • 2 Chronic alcoholic and chronic smokers 3 Subjects on antidepressant and anti-psychotic drugs 4 Subjects receiving regular medication containing any analgesic drugs.
  • 5 Patients having unexplained severe pain before operation 6 Patients who develop other complications apart from pain in post operative period 7 Patients suffering from HIV, HbsAg, VDRL, and AIDS.

Outcomes

Primary Outcomes

To establish the efficacy of Trailokya Vijaya gel compared to lignocaine gel to relieve pain after Anorectal Surgeries

Time Frame: 30 days

Secondary Outcomes

  • To know the Anaesthetic effect of Trailokya Vijaya gel(30 days)

Investigators

Sponsor
Post Graduate Institute Of Ayurved Jodhpur,Rajastan
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Tanishka Gupta

Post Graduate Institute Of Ayurved Jodhpur,Rajastan

Study Sites (1)

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