NCT03593304View on ClinicalTrials.gov

Evaluate the Neuroprotective Effect of Vitamin B6 and Vitamin B12 Against Vincristine Induced Neurotoxicity in Acute Lymphoblastic Leukaemia Patients

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 29, 2018

Primary Completion Date

December 30, 2018

Study Completion Date

March 30, 2019

Conditions
Vincristine Induced NeurotoxicityAcute Lymphoblastic Leukaemia
Interventions
DRUG

Injection Mecobalamin

Injection Mecobalamin (500mcg) three times a week (on day 1,3,5 of vincristine chemotherapy) for 5 weeks.

DRUG

Tablet Pyridoxine hydrochlorid

Tablet Pyridoxine hydrochloride (25 mg) 2 tablets thrice daily for 5 weeks.

DRUG

Normal saline

Injection Normal saline(1ml) three times a week (on day 1,3,5 of vincristine chemotherapy) for 5 weeks.

DRUG

Oral Placebo

Placebo Oral Tablet (25 mg) 2 tablets thrice daily for 5 weeks.

Trial Locations (2)

1000

Bangabandhu Sheikh Mujib Medical University, Dhaka

Unknown

Dhaka Medical College Hospital, Dhaka

All Listed Sponsors
lead

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

NCT03593304 - Evaluate the Neuroprotective Effect of Vitamin B6 and Vitamin B12 Against Vincristine Induced Neurotoxicity in Acute Lymphoblastic Leukaemia Patients | Biotech Hunter | Biotech Hunter