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
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