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Clinical Trials/CTRI/2023/05/053173
CTRI/2023/05/053173Not yet recruitingPhase 2

A pilot study to evaluate the efficacy and safety of low carb DiabeSmart Atta Additive DiabeSmart South Indian Mixture and DiabeSmart Ultra-low carb atta in lowering hyperglycemia in comparison with standard carbohydrate diet among diabetics and pre diabetics.

Bajo Foods Pvt Ltd0 sites0 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • 1.Male and female subjects aged 30-55 years both inclusive.
  • 2.Subjects with history of prediabetes (5.7-6.4%) and Diabetes mellitus â?? type II for 1-15 years.
  • 3.Diabetics with HbA1c >7.5%

Exclusion Criteria

  • 1.History of hypersensitivity to any of the study treatments, excipients, or drugs of similar chemical classes including sulfonylureas and meglitinides
  • 2.History of type 1 diabetes
  • 3.Subjects on insulin therapy
  • 4.Subjects with the history of uncontrolled hypertension and/or hyperthyroidism
  • 5.History of alcoholism
  • 6.Subjects with psychiatric or neurological disability or mental health disorder
  • 7.Subjects with serious health conditions such as cardiac disease, renal dysfunction, and cancers.
  • 8.Female subjects who are pregnant or had planned for pregnancy in the following months or were breast-feeding.
  • 9.Subjects who refuse to sign informed consent.
  • 10.Those who have participated in another clinical trial within 1 month of visit 1 or plan to participate during the clinical trial period.
  • 11.According to the investigatorâ??s opinion, participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable.
  • 12.Any planned surgery during study.

Investigators

Sponsor
Bajo Foods Pvt Ltd

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