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TO check EFFICACY OF NASAL METHYLCOBALAMIN SPRAY VERSUS ORAL METHYLCOBALAMIN IN VITAMIN B12 DEFICIENT TYPE 2 DIABETES MELLITUS PATIENTS ON METFORMIN

A STUDY TO EVALUATE SAFETY ANDEFFICACY OF NASAL METHYLCOBALAMIN SPRAY VERSUS ORAL METHYLCOBALAMIN INVITAMIN B12 DEFICIENT TYPE 2 DIABETES MELLITUS PATIENTS ON METFORMIN: A RANDOMIZED CONTROLLED TRIAL - NA

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030204
Enrollment
100
Registered
2021-01-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: E138- Other specified diabetes mellituswith unspecified complications

Interventions

Intervention1: Methylcobalamin nasal spray (250 �µg/ spray): dose of two nasal-sprays (one spray in each nostril, a total of 500 mcg of Methylcobalamin) on every alternate day for a total of 07 dose

Sponsors

Bangalore Medical College and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex aged between 18-60 years. Patients willing to give written informed consent(Annexure 1a,1b,1c) Patients who are on Metformin (�1000mg/day) therapy for �4 months with Vitamin B12 deficiency i.e. serum vitamin B12 level

Exclusion criteria

Exclusion criteria: Lactating Women Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any component of the study medication. Patients with any significant nasal pathology or having chronic nasal symptoms or nasal allergies or upper respiratory tract infections. Patients using any other nasal medication/device. Patients having a known diagnosis of severe renal impairment or renal failure. Patients on treatment with drugs which interfere with vitamin B12 assay. Participated in any clinical trial within last 30 days at the time of screening. Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome.

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of Nasal Methylcobalamin spray versus Oral Methylcobalamin in vitamin B12 deficient type 2 diabetes mellitus patients on metformin ââ?°Â¥ 4 months.Timepoint: Vitamin B12 will be assess at Baseline, day 7 and day 14—

Secondary

MeasureTime frame
To compare the safety of Nasal Methylcobalamin spray versus Oral Methylcobalamin in vitamin B12 deficient type 2 diabetes mellitus patients on metformin ââ?°Â¥ 4 monthsTimepoint: Baseline, day 7 and day 14—

Countries

India

Contacts

Public ContactDr Syed Farookh

Bangalore Medical College and Research Institute

bmccrj@gmail.com9448292424

Outcome results

None listed

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