Efficacy of Sirisha caplet with Diclofenac suppository in the management of post-operative pain.

Phase 2

Not yet recruiting

• Conditions: Other symptoms and signs involvingthe nervous and musculoskeletal systems. Ayurveda Condition: SULAH, (2) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems. Ayurveda Condition: SULAH,

• Registration Number: CTRI/2021/07/035231
• Lead Sponsor: Dr Bramhanand Subhash Chauhan

Brief Summary

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|Randomized controlled clinical study to evaluate efficacy of *Sirisha* caplet with Diclofenac suppository in the management of post-operative pain.

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|There are Paracetamol and Diclofenac suppository are available and working moderately. These drugs are having adverse effect like rectal bleeding, rectal ulceration etc. An ultimate goal of surgical treatment is approaching better recovery for a high quality of life without complications and squeals. In NBM Patients rectal administration of drugs having advantages. The rectal route may represent a practical alternative and rectal administration is now well accepted for delivering, for example, anticonvulsants, non-narcotic and narcotic analgesics, theophylline, antiemetics and antibacterial agents, and for inducing anaesthesia

Some medications can be inserted into anus (rectal) as a suppository. They may contain active ingredients that have a local effect. Rectal administration provides rapid absorption of many drug and easy alternative to Intramuscular/Intravenous route. It is a painless procedure the most important consideration are slow onset of disintegration (minutes) absorption of medicine and the prolonged duration of effect (analgesic) in rectal route.

This study plan to access efficacy of sirisha caplet in the management of post operative pain.

sample size 60

Duration 03 Days

Administration sirisha caplet 1gram per rectally

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-08
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 60 Patients will be taken in age group of 18-50 irrespective of gender.
• Post operative patient who have been operated for lower abdomen surgeries includes ilio-inguinal surgeries, Ano-rectal surgeries, pelvic floor surgeries and surgeries related to genital region.

Exclusion Criteria

• Patients who suffers from diarrhoea, Acute fissure, Active P/R Bleeding.
• CA rectum, Tuberculosis of abdomen, Dysentery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sirisha caplet is effective in post-operative pain management as a rectal analgesic. Pain assessment done by VAS scale.	03 Days

Secondary Outcome Measures

Name	Time	Method
Sirisha caplet is less/equal/more effective than Diclofenac suppository in post-operative pain management. Pain assessment done as per VAS scale.	03 Days

Trial Locations

Locations (1)

Sane Guruji Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Sane Guruji Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Bramhanand Subhash Chauhan

Principal investigator

9284645635

bramhanandc8@gmail.com