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atural sugar in the management of type-II diabetes mellitus

Phase 3
Completed
Conditions
Health Condition 1: null- type-II diabetes mellitus
Registration Number
CTRI/2011/10/002039
Lead Sponsor
Sugen Life Sciences Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
25
Inclusion Criteria

Subjects whose fasting blood glucose levels in between 90 mg/dl and 200 mg/dl and normal in blood pressure and other biochemical parameters.

Taking standard medication for the past three months

Exclusion Criteria

?Diabetic patients currently under treatment for heart disease, cancer, post-surgical patients, tuberculosis and other chronic diseases.

?Subjects who are smokers, alcoholism, chewing of various tobacco products and usage of drugs

?Subjects who are sedentary/heavy physical activity, under weight and overweight/obesity

?Subjects who are bedridden for chronic diseases for prolonged time and kidney diseases and whose serum creatinine levels are 1.5 mg/dl

?Diabetes patients taking insulin (type-1 diabetes patients)

?Subjects who had cancer, AIDS, HIV, heart failure, major surgery in past 4 years

?Pregnant women

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome variables will be NS induced changes in fasting and post-prandial blood glucose levels.Timepoint: Once in a four weeks
Secondary Outcome Measures
NameTimeMethod
I.Changes in serum concentrations of lipid profile (Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides and hemoglobin A1c). <br/ ><br>II.Changes in body weight and BMI. <br/ ><br>III.Incidence and severity of adverse events <br/ ><br>Timepoint: Once in a four weeks
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