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Randomized Clinical trial on DiabetEaze Powder to demonstrate its role in the clinical and nutritional Management of Type 2 Diabetes Mellitus and Pre-Diabetes

Prospective Randomized Clinical Study to Evaluate the Effect of DiabetEaze Powder in Nutritional Management of Pre-Diabetes and Type 2 Diabetes Mellitus

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032956
Enrollment
180
Registered
2021-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: DiabetEaze: DiabetEaze Powder is a poly herbal nutraceutical supplement contains Curcuma longa, Emblica officinalis, Strychnos potatorum, Salacia reticulata, Carum carvi, Mimosa pudica,

Sponsors

Arun Visakh Nair Pankajakasthuri Herbals India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Assessment of hypoglycaemic effect of DiabetEaze Powder. Assessment of effect of DiabetEaze Powder in Pre-Diabetes. Assessment of reduction in complications. Timepoint: Baseline, day 90, day 180 , day 365, day 545 and day 730

Countries

India

Contacts

Public ContactDr J Hareendran Nair

Pankajakasthuri Herbal Research Foundation

drshan@pkhil.com9188325339

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026