CTRI/2023/05/053173
Not Yet Recruiting
Phase 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 enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bajo Foods Pvt Ltd
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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.
Outcomes
Primary Outcomes
Not specified
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