se of thalidomide as treatment for loss of vision in Tuberculous meningitis: A Randomised Drug Trial
Phase 3
- Conditions
- Health Condition 1: G94- Other disorders of brain in diseases classified elsewhere
- Registration Number
- CTRI/2022/10/046105
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All the following:
(1) All patients of Tuberculous meningitis who have taken one month of ATT with steroids.
(2) Optochiasmatic arachnoiditis with visual impairment.
(3) Age > 12 years
Exclusion Criteria
Any of the following:
(1) Patients who have received ethambutol for at least 2 weeks preceding vision loss.
(2) Patients who have contraindication to MRI brain.
(3) Patients who are encephalopathic and in whom vision could not be checked properly .
(4)HIV positive.
(5)Patients with hepatic or renal dysfunction, malignancy, pregnancy and lactation.
(6) Patients who are diagnosed as multi drug resistant tuberculosis (MDR-TB)
(7) Patients who refuse to consent for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the improvement of vision in patients of tubercular meningitis who have visual impairment due to optochiasmatic arachnoiditis despite best medical treatment after three months of randomization.Timepoint: Primary Outcome will be measured at three months of randomization.
- Secondary Outcome Measures
Name Time Method To determine the efficacy of Thalidomide as an adjunctive treatment in improvement of vision in patients of tubercular meningitis who have visual impairment due to optochiasmatic arachnoiditis despite best medical treatment after six months of randomizationTimepoint: 6 month;To determine the efficacy of Thalidomide as an adjunctive treatment in patients of tubercular meningitis who have visual impairment due to optochiasmatic arachnoiditis despite best medical treatment in terms of radiological resolution after three and six months of randomizationTimepoint: 3 and 6 months