FindTrial
Sign In

Efficacy of cimetidine compared to standard therapy in reducing dapsone induced hematological adverse effects among chronic dapsone users

Efficacy of cimetidine compared to standard therapy in reducing dapsone induced hematological adverse effects among chronic dapsone users

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2016/009
Enrollment
Unknown
Registered
2016-03-30
Start date
2016-04-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Haematological adverse effects in chronic dapsone use

Interventions

Study setting 1.Lady Ridgeway Hospital (children) 2. National Hospital Sri Lanka (Adults) 3. Teaching hospital Colombo South (Adults) 4.Teaching Hospital Karapitiya (Adults) Participant Recruitment:

Sponsors

Lady Ridgeway Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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]

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Reduction of haemolysis using • Haemoglobin • Reticulocyte count • Blood picture [At baseline, two weeks, one month and monthly for three months ] Methaemoglobin level [At the end of 3 months]—

Secondary

MeasureTime frame
Adverse effects related to cimetidine therapy assessed using a symptom diary, patient history, examination and investigations. Common side effects 1. Diarrhea 2. Headache/Dizziness Rare side effects 3. Rash (EM.TEN) 4. Hepatitis/cholestatic jaundice 5. Bradycardia 6. Psychiatric reactions (depression, hallucinations) 7. Blood disorders (leucopenia, thrombocytopenia, pancytopenia) Very rare side effects 8. Pancreatitis 9. Vasculitis 10. Alopecia 11. Gynaecomastia/ impotence [At two weeks, one month and monthly for three months]—

Countries

Sri Lanka

Contacts

Public ContactDr. H.S. Sudusinghe

Senior Registrar in Dermatology

hssudusinghe@gmail.comTel: 0112693711

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026