A clinical study done to assess the effects of Vitamin B1 - Vitamin C adjunct therapy in patients with (external forces) traumatic insult to brain.

Completed

Conditions: Intracranial injury,

Registration Number: CTRI/2019/09/021460

Brief Summary: The knowledge of pathophysiology after Traumatic Brain Injury (TBI) has made us target the treatment towards limitation of the secondary injury (delayed non-mechanical damage) since the primary insult cannot be therapeutically limited/prevented. Thiamine and Ascorbate therapy has emerged as a promising neuroprotective intervention considering the underlying pathologic and inflammatory mechanisms of TBI. The therapy requires clinical pursuit with more extensive clinical research evidence. In this study, 160 TBI patients shall be recruited after they meet the pre-requisites for inclusion and exclusion. They shall be classified based on their baseline Glasgow Coma Scores and randomly assigned either the Study or the Control group. The study group patients will be administered study drugs. Further diagnostic workup and management of all the patients shall be undertaken as per the department protocols. Response to treatment will be recorded at pre-defined intervals, surrogated by the laid down outcome measures. Outcomes will be defined at the end of 28 days or discharge or death, whichever is earlier.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

1.Adult patients (18 â€“ 60 yrs) with an ASA physical status I and II of either sex 2.History of Traumatic Brain Injury 3.Patients getting admitted to the Trauma ICU with head injury, whether operated or not.

Exclusion Criteria

1.Patients below 18yrs or above 60yrs 2.Pregnant women 3.Patients with G-6-PD deficiency 4.Patients with a history of nephrolithiasis/Gout/renal disorders/chronic renal failure 5.Immunocompromised patients (taking >10 mg of prednisone equivalent per day for at least 2 weeks, receiving cytotoxic therapy or diagnosed with an acquired immunodeficiency syndrome) 6.Chronic alcoholics/liver disease patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	28 days

Secondary Outcome Measures

Name	Time	Method
Days of ICU stay	Serum Lactate levels

Trial Locations

Locations (1): Intensive Care Unit, Trauma Centre, Banaras Hindu University, Varanasi, Uttar Pradesh
🇮🇳
Varanasi, UTTAR PRADESH, India
Intensive Care Unit, Trauma Centre, Banaras Hindu University, Varanasi, Uttar Pradesh
🇮🇳Varanasi, UTTAR PRADESH, India
Dr Garima Sinha
Principal investigator
9916441927
garimasinha.doc@gmail.com