None listed
Conditions
Interventions
Intervention1: ViphyllinTM 100mg: Single day, Single dose administration of 100mg of ViphyllinTM
Intervention2: ViphyllinTM 250mg: Single day, Single dose administration of 250mg of ViphyllinTM
Interv
Sponsors
Vidya Herbs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Should not be on any regular medications or supplementation for pain. 2. Must be willing and able to give informed consent and comply with the study procedures. 3. Should be ready to abstain from alcohol consumption, smoking and consumption of caffeinated beverages.
Exclusion criteria
Exclusion criteria: 1.Subjects who are experiencing pain currently due to any cause or with history of acute or chronic pain. 2. Subject with ability to withstand the CPT for the maximum 3 minutes (to avoid a ceiling effect). 3. Subjects having symptoms of viral infection, including COVID-19 infection 4. Subject with clinically significant abnormalities in blood pressure, heart rate, ECG recording and laboratory parameters 5. Regularly on over the counter or prescribed medication 6. Subjects with known hypersensitivity to the investigational products. 7. Alcohol/drug addicts, smokers of more than 10 cigarettes/day. 8. Pregnant and lactating women 9. Currently participating or having participated in another clinical trial during the last 1 month prior to the beginning of this study 10. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Pain threshold, Pain tolerance and Subjective ratings of Pain across study periodsTimepoint: Baseline, 1.5 hour, 3 hour and 5 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in heart rate before and after CPT across study periods 2. Change from baseline in Blood pressure before and after CPT across study periods 3. Change from baseline in ECG reading before and after CPT across study perioTimepoint: Baseline, 1.5 hour, 3 hour and 5 hours | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Private Limited
Outcome results
None listed