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Clinical Trials/CTRI/2023/07/055787
CTRI/2023/07/055787Not yet recruitingPhase 2/3

A comparative clinical trial to evaluate the efficacy of Eranda suppository & Diclofenac suppository in the management of post Haemorrhoidectomy pain.

Dr Yogesh Kanna V1 site in 1 country30 target enrollmentStarted: October 8, 2023Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
- Pain

Study Overview

Brief Summary

Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage . Proper pain management in postoperative period is essential as it is associated with stress and systemic complication that include chiefly pulmonary, cardiovascular and gastro intestinal system.The prevalence of Post-operative pain was 84.17 % in 5th post Operative hour, 92.5% in 2nd post-operative day and 96.66% in 3rd post-operative day.The incidence of moderate to severe pain following conventional haemorrhoidectomy reported in the literature as high as 65% .Many patient are reluctant to submit to haemorrhoidectomy because the operation has become notorious of being associated with a great deal of Post operative pain .Most commonly opioids and NSAIDS are used as analgesics in Post operative period. Rectal suppositories are intended for localized or systemic action to relieve pain. Diclofenac suppository is one of the widely used analgesic into rectum especially in post haemorrhoidectomy. But it has limited effectiveness, safety and high risk factors such as headache, hypertension, drowsiness, local rectal irritation, rectal bleeding, black stool, persistent stomach pain and allergic reaction like rashes, itching and swelling may develop .Acharya Susrutha mentions there is no ruja without vata .Varti Kalpana is the derivative of vati Kalpana. Guda varti is type of varti which is inserted to rectum. It helps to expel the sanchita dosha .Eranda is having properties such as vatahara, margasodhana and it is indicated in Shula and Shopha .Suppository is the modification of Varti kalpana. So a Suppository is prepared out of Eranda which will be helpful in Post-operative pain.So current study is to evaluate the efficacy of Eranda suppository and Diclofenac suppository in the post haemorrhoidectomy pain management.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

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

Inclusion Criteria

  • Subjects who have undergone Haemorrhoidectomy will be included irrespective of the gender, occupation and religion.
  • Subjects from 20 to 60 years will be included to the study.

Exclusion Criteria

  • Subjects who have undergone Haemorrhoidectomy along with combined surgeries for fissure, fistula, infected case, abscess to be excluded.

Outcomes

Primary Outcomes

- Pain

Time Frame: Assessment will be done POD-0 POD-1 POD- 2 & POD-3(24th hourly).

Secondary Outcomes

  • -Tenderness(Assessment will be done POD-0 POD-1 POD- 2 & POD-3(24th hourly).)

Investigators

Sponsor
Dr Yogesh Kanna V
Sponsor Class
Other [self]

Study Sites (1)

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