Clinical trial with 0.5% salbutamol ointment for cold injuries
- Registration Number
- CTRI/2010/091/001442
- Lead Sponsor
- Defence R&D Organisation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 150
Healthy volunteers
1. Healthy Males/females, between 18-65 years ages group
2. On no permanent treatment
3. Suffering from no permanent / recurrent / chronic disease or disability
Diseased subjects
a) Mild cold injury
1. Painful cold periphery (hands & feet) attributed to cold injury in appropriate weather conditions.
2. Age group: 18-65 years
3. Ambulatory, preferably confined patients for better follow-up
4. Assured availability for 7-10 days
5. Non-critically ill patients.
6. Educated persons capable of self assessment (quantitative)
b) Significant cold injury
1. Age group: 18-65 years
2. One or more frostbite lesions (superficial / deep)
3. Ambulatory, preferably confined patients for better follow-up
4. Assured availability for 7-10 days
5. Non-critically ill patients
6. Educated persons capable of self assessment (quantitative)
Healthy volunteers
1. Those who do not sign the ICF
2. Those who refuse to abide by the rules/briefing
3. Those who have had any medical condition which in the judgment of the investigator may render them inappropriate for participation in the trial.
4. Patients who have received any other investigational drug for the last 1 month.
5. Too low or too high body weight (< 40 kg, > 100 kg).
Diseased subjects
1. Patients with prior hypersensitivity to salbutamol
2. Patients who are unwilling to give informed consent.
3. Patients receiving beta-agonists within 1 week of the start of the study with persisting medical effect.
4. Patients with very large lesions, extensively broken / ulcerated skin
5. Volunteers with serious or critical illness.
6. Patients who are pregnant, lactating or women of child bearing potential not using medically accepted methods of contraception (except those with severe disease and who are likely to be benefit in the clinical judgment of clinician in charge).
7. Patients with skin disease in the area of cold injury / other lesions.
8. Patients with clinically significant renal, respiratory (other than those mentioned), cardiac (including rheumatic or congenital heart disease), gastrointestinal, hepatic, endocrine or hematological disorders.
9. Patients who have any medical condition which in the judgment of the investigator may render them inappropriate for participation in the trial.
10. Patients who have received any other investigational drug for the last 1 month
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To further confirm the beneficial effect of short-term treatment with 0.5% salbutamol sulphate ointment in treatment of mild cold injuries (without tissue loss) in a large cohort<br><br>2. To compare the efficacy of short-term treatment with 0.5% salbutamol sulphate ointment in mild cold injuries with the existing art.<br><br>3. To evaluate the effect of short-term treatment with 0.5% salbutamol sulphate ointment in treating significant cold injuries (with tissue loss) as a collateral or adjuvant therapy.<br><br>4. To evaluate the effect of short-term treatment with 0.5% salbutamol sulphate ointment on reliving pain and improving muscular efficiency in cold injuries.<br>Timepoint: NI
- Secondary Outcome Measures
Name Time Method 1. To evaluate the safety and tolerability of study medication<br><br>2. To generate further pharmacokinetic data of the drug and peak serum salbutamol sulphate levels upon dermal application, including on devitalized / ulcerated skin in the prescribed doses.<br><br>3. To evaluate the physicians? and patients? overall assessment of the effectiveness and tolerability of the study medication <br><br>4. To evaluate the test medication in other peripheral microangiopathies.<br>Timepoint: NI