Health Condition 1: O- Medical and Surgical
Conditions
Interventions
None listed
Sponsors
Pankajakasthuri Herbals India Pvt Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. The next objective is to assess the tolerability and safety profiles on single dose administration of polyherbal local anaesthetic in the test subjects Timepoint: During the therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| ï?¶ Checking the Nociception, Touch and Pain sensation up to 60 minutes ï?¶ To find out any other therapeutic properties like antiinflammatory activity. Timepoint: During therapy | — |
Countries
India
Contacts
Public ContactShan Sasidharan
Pankajakasthuri Herbal Research Foundation
Outcome results
None listed