A clinical trial to study the effects of two drugs, eranda suppository & diclofenac suppository in patients with post operative haemorrhoidectomy pain

Phase 2/3

Not yet recruiting

Conditions: Unspecified hemorrhoids. Ayurveda Condition: ARSAH,

Registration Number: CTRI/2023/07/055787

Lead Sponsor: Dr Yogesh Kanna V

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Pain	Assessment will be done POD-0 POD-1 POD- 2 & POD-3(24th hourly).

Secondary Outcome Measures

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

Trial Locations

Locations (1): S D M Institute of Ayurveda & Hospital
🇮🇳
Bangalore, KARNATAKA, India
S D M Institute of Ayurveda & Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Yogesh Kanna V
Principal investigator
9080560098
yogeshkannav@sdmayurbangalore.in