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Clinical Trials/CTRI/2022/08/044754
CTRI/2022/08/044754
Not yet recruiting
未知

A prospective, open-label, single-arm clinical study to evaluate the safety andeffectiveness of novel Methylcobalamin nasal spray in the treatment of subjects withvitamin B 12 deficiency.

Dr Banshi Saboo0 sites0 target enrollmentTBD
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Dr Banshi Saboo
Status
Not yet recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Observational

Investigators

Sponsor
Dr Banshi Saboo

Eligibility Criteria

Inclusion Criteria

  • •1\) Vitamin B12 level \< 200 pg/mL (148 pmol/L)
  • •2\) Above the age of 18 years
  • •3\) Willing \& able to comply with study requirements, e.g. usage of medicines as per
  • •protocol, willing to adhere to study visit schedule, and willing to fill Patient Diary, as
  • •indicated by written informed consent provided by the patient.
  • •4\) If women of childbearing potential are recruited they must be non\-pregnant
  • •(supported by a negative urine pregnancy test at screening), and be willing to maintain
  • •reliable birth control throughout the study.

Exclusion Criteria

  • •1\) Lactating Women
  • •Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any
  • •component of the study medication.
  • •2\) Patients with any significant nasal pathology, or having chronic nasal symptoms or
  • •nasal allergies, or upper respiratory tract infections.
  • •3\) Patient using any other nasal medication/device.
  • •4\) Patients having a known diagnosis of severe renal/hepatic impairment or renal/hepatic
  • •Patients on treatment with drugs that interfere with vitamin B12 assay.
  • •5\) Participated in any clinical trial within the last 30 days at the time of screening.
  • •6\) Any disorder or condition that in the opinion of the investigator would prohibit study

Outcomes

Primary Outcomes

Not specified

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