Use of thalidomide as treatment for loss of vision in Tuberculous meningitis: A Randomised Drug Trial

Thalidomide as treatment of optochiasmatic arachnoiditis in Tuberculous meningitis: A prospective randomized open blinded endpoint (PROBE) study.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/10/046105

Enrollment

Registered

2022-10-03

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

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

Conditions

Health Condition 1: G94- Other disorders of brain in diseases classified elsewhere

Interventions

Intervention1: Thalidomide: Patients: Patients of tubercular meningitis who have visual impairment due to optochiasmatic arachnoiditis and has taken at least 1 month of ATT with steroids â?¥12 years

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

India

Contacts

Public ContactRajesh kumar singh

AIIMS, Delhi

drrajeshrims679@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026