To Understand blood sugar control with herbal supplement product in newly identified type II diabetes mellitus subjects

Not Applicable

Completed

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2021/04/033094
• Lead Sponsor: Herbalyn Lifesciences Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-10
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

a.Male or female patients of 25 to 60 years, both inclusive

b.Have newly diagnosed treatment na�¯ve type II diabetes for greater than or equal to 3 months based on the disease diagnostic criteria.

c.Subjects are treatment-na�¯ve, not optimally controlled with diet and exercise alone, not received treatment with any anti-hyperglycemic medications.

d.Fasting Plasma Glucose more than or equal to 120 mg/dL to less than or equal to 150 mg/dl in the subject.

e.Have a body mass index (BMI) less than or equal to 35.00 kg/m2.

f.Subject who will follow all study related procedures and willing to take rescue medication for use as per requirement for the duration of the study.

Exclusion Criteria

a.Pregnant or lactating or planning to become pregnant and women with reproductive potential unwilling to follow standard contraception methods.

b.Subjects having type 1 diabetes mellitus, gestational diabetes, secondary diabetes.

c.Any history suggestive of microvascular or macrovascular disease

d.Impaired renal function; eGFR less than 60 ml/min/1.73 m2

e.Known history of any chronic illness taking regular pharmacological agents

f.Subjects diagnosed with uncontrolled hypertension.

g.Subjects who have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed within 60 days prior to screening.

h.History of asthma, hypertension, thrombotic events, stroke, congestive heart failure, impaired cognitive function, and impaired hepatic function.

i.Known hypersensitivity to any of the study products.

j.History of use of any nutraceutical products in the last four weeks prior to screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified