| CTRI Number |
CTRI/2025/09/095293 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of long duration steroid treatment in comparison to standard steroid treatment on proinflammatory cytokines in patients of TB Meningitis |
|
Scientific Title of Study
|
Evaluation of the effect of standard corticosteroid treatment compared to extended adjunctive corticosteroid treatment on proinflammatory cytokines in paradoxical reactions in tuberculous meningitis: A Randomized control trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2025-76-IMP-143,PGI/BE/178/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prakash Chandra Pandey |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department Of Neurology
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Raebareli Road
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9454019246 |
| Fax |
|
| Email |
drprakashpandey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prakash Chandra Pandey |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department Of Neurology
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Raebareli Road
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9454019246 |
| Fax |
|
| Email |
drprakashpandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prakash Chandra Pandey |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department Of Neurology
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Raebareli Road
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9454019246 |
| Fax |
|
| Email |
drprakashpandey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Project
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, UP, India, Pin- 226014 |
|
|
Primary Sponsor
|
| Name |
Prakash Chandra Pandey |
| Address |
Department Of Neurology
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow,UP, India, Pin- 226014 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prakash Chandra Pandey |
Sanjay Gandhi Post Graduate Institute of Medical Sciences Raebareli Road, Lucknow, UP, India |
Department Of Neurology
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Raebareli Road, Lucknow,UP,India,Pin-226014
Lucknow
UTTAR PRADESH |
09454019246
drprakashpandey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road,Lucknow,226014 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A170||Tuberculous meningitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
The number of tablets between the two groups will be maintained by giving identical saccharine tablets. |
| Intervention |
Prednisolone |
Intervention-
First Group-
Prednisolone(0.75mg/kg/day, maximum 40mg/day) for 3 month, then taper in the next month
Frequency Once Daily
Route Oral
Total duration Three months
Second Group-
Prednisolone(0.75mg/kg/day, maximum 40mg/day) for one month, then taper in the next month followed by placebo
Frequency Once Daily
Route Oral
Total duration One months
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with TBM
The essential criteria include presence of meningitis symptoms comprising of fever, headache and vomiting for two week or more. The supportive criteria include (1) CSF cells 0.1 x 109/l or more with predominant lymphocytes, protein more than 1 gm/l, sterile bacterial and fungal culture; (2) CT or MRI scan evidences of exudates, infarctions, hydrocephalus and tuberculoma in isolation or in various combinations; (3) evidence of extra central nervous system tuberculosis and (4) response to anti-tubercular therapy. Presence of essential and 3 of 4 supportive criteria will be considered highly probable and 2 supportive criteria as probable TBM. Presence of AFB in CSF smear or culture, positive PCR for M. tuberculosis in CSF will be considered definitive evidence of TBM |
|
| ExclusionCriteria |
| Details |
Patients with malaria, septic, fungal and carcinomatous meningitis, HIV, resistant TB, head injury, stroke, tumors, malignancy, chronic renal failure, hepatic failure, heart failure, chronic obstructive pulmonary disease, asthma, Age less than 15 years or more than 70 years, pregnancy, lactation, and those having life expectancy less than 6month due to other disease will be excluded |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in levels of cytokines TNF Alpha, IL Six , and IL Ten |
Baseline,6 Weeks & 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Paradoxical Reaction
Death within 3month
Functional outcome at 3 & 6 months using modified Rankin Scale (mRS).
Occurrence of drug induced hepatitis
Occurrence of CSW
Occurrence of visual loss
Corticosteroid related side effects: hypertension, weight gain, hyperglycemia, infection, fracture etc
|
6 weeks & 3 months
|
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tuberculous meningitis is the most severe TB form, with a 20–30 percent mortality rate and neurological sequelae in up to 78 percent of survivors. Treatment response varies, with paradoxical reactions occurring in 40–60 percent of patients. PR is characterized by clinical or radiological worsening within three months of antitubercular treatment after initial stabilization. Paradoxical tuberculoma refers to new or enlarged tuberculomas post-ATT. In HIV-associated TB, TB IRIS immune reconstitution inflammatory syndrome, presents as inflammatory symptoms within three months of antiretroviral therapy , reported in 15.7 percent of cases. PR and IRIS are attributed to Mycobacterium tuberculosis antigen load and host immune response, with contributing factors including excessive inflammation, high proinflammatory cytokines, CD4 count, and genetic polymorphisms. Adjunctive corticosteroids reduce TBM mortality and are typically given for one month. Elevated TNF alpha, IL Six and IL Ten in PR patients, suggesting excessive inflammation. Extended prednisolone use may suppress these biomarkers, potentially reducing PR incidence. Further evaluation of extended corticosteroid therapy is needed to optimize TBM management and improve patient outcomes. |