ââ?¬Å?To compare the Effectiveness and Safety between Thalidomide and Azathioprine in type two lepra reaction: A Randomized Controlled Trialââ?¬?
Phase 3
- Conditions
- Health Condition 1: A309- Leprosy, unspecified
- Registration Number
- CTRI/2022/09/045482
- Lead Sponsor
- Deepak Kumar Sahu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
i.Patients with severe ENL of any gender and age >18 years.
ii.Patients willing to participate and willing to follow up for nine months
Exclusion Criteria
i.Patients with known immunosuppression
ii.Patients with severe ENL on any steroid-sparing agents within the last one month
iii.Pregnancy and lactation
iv.Patients with a history of hypersensitivity to thalidomide or azathioprine
v.Patients with hemoglobin less than 10 gm/dl
vi.Patients with HIV, Hepatitis B and C infection.
vii.Patients who will deny giving consent to the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients achieving remission at six month and nine months (Remission is defined as subsidence of all features of ENL with ENL International Study Group Severity Scale score of zero when the patient is off prednisolone or minimal prednisolone dose of 10mg or less)Timepoint: six month and nine months
- Secondary Outcome Measures
Name Time Method umber of ENL flaresTimepoint: Nine months;Change in DLQI from the baselineTimepoint: end of nine month;Pathological differences between acute versus chronic/recurrent ENLTimepoint: nine months;Side effect profiles (frequency, nature and severity)Timepoint: within nine months;The correlation between EESS( ENLIST ENL Severity Score) and serum interferon-gamma levels <br/ ><br>NB: Optional subject to thesis grant approveTimepoint: nine months;The cumulative dose of prednisoloneTimepoint: nine months;Time to ENL flareTimepoint: within nine months;Time to initial remissionTimepoint: within nine months