Clinical study to find out the safety and efficacy of Injection Harsha 22, a polyherbal anesthetic agent
Phase 2
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2023/01/049167
- Lead Sponsor
- Pankajakasthuri Herbals India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- 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.Timepoint: ain will be assessed in 5 timepoints. <br/ ><br>Time 1 â?? During initial local anaesthetic injection. <br/ ><br>Time 2 â?? During the surgical procedure. <br/ ><br>Time 3 â?? Immediately after the procedure. <br/ ><br>Time 4 â?? 4 hours after procedure. <br/ ><br>Time 5 â?? 24 hours after procedure.
- Secondary Outcome Measures
Name Time Method 1.Evaluation of Safety parameters of the Injection Harsha 22 by assessing LFT, RFT, CRP. <br/ ><br>2.Assessing unusual oedema/inflammation, delayed wound healing and wound infection. <br/ ><br>3.To find out the other therapeutic properties. <br/ ><br>4.Finally, to access the pharmacoeconomical feasibility of Injection Harsha 22 when compared to that of SOC. <br/ ><br>Timepoint: Time 1 â?? Baseline â?? will be assessed before intervention. <br/ ><br>Time 2 â?? 2 weeks after intervention. <br/ ><br> <br/ ><br>Swelling, Delayed wound healing and wound infection will be assessed 2 weeks after intervention.