To Compare benefit of two doses of a drug folinic acid in patients who develop harmful effects due to overdose of the drug methotrexate
Phase 3
Completed
- Conditions
- Health Condition 1: T451- Poisoning by, adverse effect of and underdosing of antineoplastic and immunosuppressive drugs
- Registration Number
- CTRI/2019/09/021152
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 38
Inclusion Criteria
1 A patient prescribed weekly or the biweekly dose of tablet or parenteral Methotrexate (up to 50 mg per week) for rheumatic or dermatologic or gastrointestinal disease
2 Patient having methotrexate hematologic Toxicity defined as EITHER WBC less than 2000 AND OR Platelet count less than 50000 per microlitre (with or without mucositis)
3 Either inadvertent overdose OR renal dysfunction
Exclusion Criteria
1 Patient not consenting for the study
2 Patient being treated with High Dose Methotrexate regimen.
3 Patient <12 years of age
4 Patient already received more than one dose of folinic acid
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method