Clinical study to find out the safety and efficacy of a polyherbal local anaesthetic parenteral formulatio
Phase 1
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/04/042091
- Lead Sponsor
- Pankajakasthuri Herbals India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Healthy volunteers
Has a legally acceptable representative capable of under standing the informed consent documents and providing consent on the participants behalf
Normal laboratory values in CBC, LFT and RFT
Non smokers, non substance abusers, non alcoholic
Exclusion Criteria
1.Pregnant or breastfeeding women.
2.Body mass index superior to 35�kg/m2.
3.Allergy to any one of the ingredients in the formulation.
4.Uncontrolled hypertension/congenital heart problems.
5.Life-threatening comorbidities.
6.Adults legally protected (under judicial protection, guardianship or supervision) and persons deprived of their liberty.
7.Those who are taking regular medication
8.Any other chronic illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary out of the study is to assess the safety and efficacy on single-dose administration of polyherbal local anaesthetic formulation in healthy adults. <br/ ><br>The next objective is to assess the tolerability and safety profiles on single dose administration of polyherbal local anaesthetic in the test subjects <br/ ><br>Timepoint: During the therapy
- Secondary Outcome Measures
Name Time Method ï?¶Checking the Nociception, Touch and Pain sensation up to 60 minutes <br/ ><br>ï?¶To find out any other therapeutic properties like antiinflammatory activity. <br/ ><br>Timepoint: During therapy