A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF CHANGERI GHRITA SUPPOSITORY WITH DICLOFENAC SODIUM SUPPOSITORY IN THE MANAGEMENT OF POST OPERATIVE HAEMORRHOIDECTOMY PAIN.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Reduction in post-operative pain score measured by Visual Analogur scale (VAS)
Study Overview
Brief Summary
This randomized, parallel-group, active-controlled interventional study aims to compare the efficacy of Changeri Ghrita suppository and Diclofenac sodium (75 mg) suppository in managing post-operative pain following hemorrhoidectomy. 40 patients will be enrolled, with 20 in each group. Changeri Ghrita suppositories will be prepared according to Bhaishajya Ratnavali and administered rectally every 12 hours for five days, while Diclofenac suppositories will be administered similarly. The primary outcome is reduction in post-operative pain measured by Visual Analog Scale (VAS). Secondary outcomes include tenderness, burning sensation, duration of pain relief, recurrence, and rescue analgesic use.
This study seeks to determine whether Changeri Ghrita suppository is a safe and effective alternative to standard Diclofenac suppository for post-hemorrhoidectomy pain management.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients undergoing Haemorrhoidectomy .
- •Patients between the age group of 20-60 years.
- •Irrespective of gender and occupations.
- •Controlled Diabetic and Hypertensive patients will be selected for the study.
Exclusion Criteria
- •Patient suffering from systemic diseases like Uncontrolled Diabeties and Hypertention, Tuberculosis, Rheumatoid arthritis.
- •patients with haemorrhoids with IBS and Crohns disease.
- •Postive cases of HIV, VDRL,Hepatitis B, Leprosy.Post operative cases with complications like Severe bleeding , wound sepsis .
- •Cases of Haemorrhoids with fissure, fistula in ano, ischio rectal abscess , perianal abscess and CA Rectum.
Outcomes
Primary Outcomes
Reduction in post-operative pain score measured by Visual Analogur scale (VAS)
Time Frame: at baseline (0 hrs), 12 hrs, 24 hrs, 48 hrs,72 hrs,96hrs and 120 hrs
Secondary Outcomes
- Burning pain at site of insertion -(Grade 1-present)
- Tendernessat operative site measured clinically as(Grade1- present)
- Duration of pain reduction (after suppository insertion)(Grade1- reduction after 30 mins)
- Reoccurence of pain(Grade 1- no pain)
- Rescue analgesic requirement yes or no(number of dose required)
Investigators
RAHUL GASTI
SHRI SHIVAYOGEESHWAR RURAL AYURVEDIC MEDICAL COLLEGE AND HOSPTIAL, INCHAL