Comparison of effect of inactive drug prescribed with and without information to subjects on pain perception after cold water exposure in healthy human volunteers
Not Applicable
Completed
- Registration Number
- CTRI/2019/03/018168
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 69
Inclusion Criteria
1. Healthy volunteers age between 20-45 years
2. Willing to give informed consent for the study
Exclusion Criteria
1. Any known cardiovascular disease like hypertension, coronary artery disease, and peripheral vascular disease.
2. History of any acute or chronic pain disorders like migraine and arthritis or any chronic disease like diabetes, tuberculosis, epilepsy, asthma, and malignancy.
3. History of an allergic reaction to topical lignocaine application
4. History of drug intake for any disease within the last 1 week
5. External injuries or any skin disease on hands
6. Female subjects should not be a pregnant or nursing mother
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of pain perception as measured by pain threshold, pain tolerance (in the form of time) and pain intensity (on Visual Analogue Scale) between the open label placebo and double blind placebo group.Timepoint: at the time of enrollment and then next day
- Secondary Outcome Measures
Name Time Method Comparison of pain perception as measured by pain threshold, pain tolerance (in the form of time) and pain intensity (on Visual Analogue Scale) among the open label placebo open label treatment, double blind treatment and double blind placebo group.Timepoint: at the time of enrollment and then next day