CTRI/2021/04/032956
Recruiting
Phase 4
Prospective Randomized Clinical Study to Evaluate the Effect of DiabetEaze Powder in Nutritional Management of Pre-Diabetes and Type 2 Diabetes Mellitus
Arun Visakh Nair Pankajakasthuri Herbals India Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Sponsor
- Arun Visakh Nair Pankajakasthuri Herbals India Pvt Ltd
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Willing to sign consent form.
- •2\.Men and Women aged 40 years or greater and not older than 65 years.
- •3\.Subjects with clinical evidence of Type 2 Diabetes Mellitus.
- •4\.Subjects of Pre\-Diabetes with HbA1c range between 5\.7% and 6\.4% and/or OGTT range between 140 mg/dl and 199 mg/dl.
Exclusion Criteria
- •1\.Presence of conditions like Medical, Psychological, Social or Alcohol abuse that would interfere with participation in the trial.
- •2\.Subjects with known allergy to any of the ingredients of the drug product.
- •3\.Pregnant or Lactating women.
- •4\.Subjects with Type1 Diabetes Mellitus.
- •5\.Subjects undergoing Insulin therapy.
- •6\.Other conditions like CKD, Malignancies etc.
- •7\.Post\-surgical cases mainly GI diseases.
- •8\.Patients under Steroid intake.
Outcomes
Primary Outcomes
Not specified
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