Clinical study to find out the safety and efficacy of a polyherbal local anaesthetic parenteral formulatio

Phase 2

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2022/06/043126
• Lead Sponsor: Pankajakasthuri Herbals India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Subjects indicated for minor surgical procedures under Local anaesthesia; Willing to enroll in the study by signing the informed consent.

Exclusion Criteria

1. Hypersensitivity to any one of the ingredients in the polyherbal local anaesthetic injection, lignocaine hydrochloride or to any local anaesthetic agent of amide type.

2. Uncontrolled hypertension/congenital heart problems.

3. Any chronic illness with life-threatening comorbidities.

4. Impaired cardiovascular and respiratory function.

5. Patients with medicament-induced altered pain perception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Primary outcome of the trial is induction of adequate local anaesthetic effect / analgesia for performing a minor surgical procedure. <br/ ><br> <br/ ><br>2. Pain will be assessed using VAS Score from 0 to 10 (0 ââ?¬â?? no pain, 10 ââ?¬â?? most severe pain) <br/ ><br>Timepoint: Pain will be assessed in 5 timepoints. <br/ ><br>Time 1 ââ?¬â?? During initial local anaesthetic injection. <br/ ><br>Time 2 ââ?¬â?? During the surgical procedure. <br/ ><br>Time 3 ââ?¬â?? Immediately after the procedure. <br/ ><br>Time 4 ââ?¬â?? 4 hours after procedure. <br/ ><br>Time 5 ââ?¬â?? 24 hours after procedure. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Evaluation of Safety parameters of the drug by assessing LFT, RFT, CRP. <br/ ><br> <br/ ><br> <br/ ><br>2. Assessing unusual swelling, delayed wound healing and wound infection. <br/ ><br>Timepoint: Time 1 ââ?¬â?? Baseline ââ?¬â?? will be assessed before intervention. <br/ ><br>Time 2 ââ?¬â?? 2 weeks after intervention. <br/ ><br> <br/ ><br>Swelling, Delayed wound healing and wound infection will be assessed 2 weeks after intervention. <br/ ><br>