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Comparison of effect of inactive drug prescribed with and without information to subjects on pain perception after cold water exposure in healthy human volunteers

Open-label placebo versus double-blind placebo treatment for experimentally induced pain in healthy volunteers: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018168
Enrollment
40
Registered
2019-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: commercially available KY jelly applied topically as open label placebo: 3 times application (with 10-15 minutes interval) of 1 Finger Tip unit (approx. 0.5 gm) of commercially availabl

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers age between 20-45 years 2. Willing to give informed consent for the study

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactShashikant Bhargava

All India Institute of Medical Sciences, New Delhi

scsarangi@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026