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
Dr Tanishka Gupta
Post Graduate Institute Of Ayurved Jodhpur,Rajastan
Study Sites (1)
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