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Clinical Trials/CTRI/2024/10/075521
CTRI/2024/10/075521
Completed
Phase 2

comparing the therapeutic effects of intranasal, intramuscular, intravenous B12 administration on haematological parameters in B12 deficiency anaemia

Armed Forces Medical College1 site in 1 country100 target enrollmentStarted: October 30, 2024Last updated:

Overview

Phase
Phase 2
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
COMPARE THE CHANGE IN HEMATOLOGICAL PARAMETERS (HAEMOGLOBIN, MEAN CORPUSCULAR VOLUME)

Overview

Brief Summary

A total of 100 patients will be enrolled in the study. These 100 patients will be randomised by computer generated random number sequence into three groups. All patients who are diagnosed as B12 deficiency will be administered intravenous, intramuscular and nasal B12 based on treatment protocol. The response in hematological parameters will be assessed on 07th, 14th and 28th day of treatment.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All patients diagnosed with B12 deficiency anaemia.
  • Willingness to give consent.

Exclusion Criteria

  • Pregnant females
  • All other causes of anaemia
  • Requiring blood transfusion at initiation of therapy.

Outcomes

Primary Outcomes

COMPARE THE CHANGE IN HEMATOLOGICAL PARAMETERS (HAEMOGLOBIN, MEAN CORPUSCULAR VOLUME)

Time Frame: COMPARE THE CHANGE IN HEMATOLOGICAL PARAMETERS (HAEMOGLOBIN, MEAN CORPUSCULAR VOLUME) ON DAY 14 AND DAY 28 IN EACH GROUP (INTRAVENOUS, INTRAMSCULAR AND NASAL B12 TREATMENT AS PER ESTABLISHED GUIDELINES)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Rahil Arora

Armed Forces Medical College

Study Sites (1)

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