Randomized Clinical trial on DiabetEaze Powder to demonstrate its role in the clinical and nutritional Management of Type 2 Diabetes Mellitus and Pre-Diabetes
Phase 4
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2021/04/032956
- Lead Sponsor
- Arun Visakh Nair Pankajakasthuri Herbals India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Nutritional Assessment of DiabetEaze Powder in Type 2 DM,To assess the variation in Quality of Life in terms of direct symptoms, To assess the role of DiabetEaze Powder in managing nutritional inadequacy in DMTimepoint: Baseline, day 90, day 180 , day 365, day 545 and day 730
- Secondary Outcome Measures
Name Time Method Assessment of hypoglycaemic effect of DiabetEaze Powder. <br/ ><br>Assessment of effect of DiabetEaze Powder in Pre-Diabetes. <br/ ><br>Assessment of reduction in complications. <br/ ><br>Timepoint: Baseline, day 90, day 180 , day 365, day 545 and day 730