Efficacy of cimetidine compared to standard therapy in reducing dapsone induced hematological adverse effects among chronic dapsone users
- Conditions
- Haematological adverse effects in chronic dapsone use
- Registration Number
- SLCTR/2016/009
- Lead Sponsor
- ady Ridgeway Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
1. Male and female patients aged 10-60 years
2. Long-term dapsone therapy (>3 months) indicated [e.g. in leprosy, auto-immune blistering diseases (pemphigus vulgaris, bullous pemphigoid, dermatitis herpetiformis, linear IgA disease), vasculitis]
1.Diagnosed liver disease and/or any degree of elevated AST/ALT at
recruitment
2.Diagnosed renal disease and/or any degree of elevated serum creatinine at recruitment
3.Haemoglobin <10g/dl
4. Cytopaenias and/or other haematological diseases (lymphoproliferative/myeloproliferative)
5. Diabetes Mellitus
6. Epilepsy
7. Cardiac disease (NYHA grade 2 and above)
8. Diagnosed psychiatric illness
9. Prisoners and other institutionalized patients
10. Patients currently on any long term medications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of haemolysis using<br>• Haemoglobin<br>• Reticulocyte count<br>• Blood picture [At baseline, two weeks, one month and monthly for three months<br>]<br>Methaemoglobin level [At the end of 3 months]<br>
- Secondary Outcome Measures
Name Time Method Adverse effects related to cimetidine therapy assessed using a symptom diary, patient history, examination and investigations.<br><br>Common side effects<br>1. Diarrhea<br>2. Headache/Dizziness<br><br>Rare side effects<br>3. Rash (EM.TEN) <br>4. Hepatitis/cholestatic jaundice<br>5. Bradycardia<br>6. Psychiatric reactions (depression, hallucinations) <br>7. Blood disorders (leucopenia, thrombocytopenia, pancytopenia)<br><br>Very rare side effects<br>8. Pancreatitis<br>9. Vasculitis<br>10. Alopecia<br>11. Gynaecomastia/ impotence<br> [At two weeks, one month and monthly for three months]<br>