Study on Simpl - A nutritional powdered supplement to control blood sugar levels in adults (diabetes)
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2022/07/043880
- Lead Sponsor
- Essen Fooddies India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Adult subjects between 30 and 65 years (both ages and all genders inclusive)
2.Subjects with history of Diabetes Mellitus Type II treated only by oral hypoglycemic agents and/or insulin.
3.Subjects who are willing to follow Diabetic friendly diet and exercise (walking) for a minimum of 30 minutes per day.
4.Subjects who are non-alcoholic and non-smokers/non-users of tobacco.
5.Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
6.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
1.Subjects with allergy, sensitivity or intolerance to the study drugs and their formulation ingredients
2.Subjects with Galactosemia, and any other disorder that limits normal nutritional intake
3.Subjects on drugs, supplements, therapy regimens intended for the treatment of obesity upto 3 months prior to the date of screening.
4.Subjects with a history of significant cardiovascular disease (eg, congestive heart failure New York Heart Association Grade III/IV, arrhythmia known to increase the risk of thromboembolic events [e.g., atrial fibrillation], coronary artery stent placement, angioplasty, and coronary artery bypass grafting); Coronary artery bypass graft (CABG), Percutaneous transluminal coronary angioplasty (PTCA)
5.Subjects who have clinically abnormal renal or hepatic function values that are 3x times normal upper limit or in the opinion of the Investigator would impact the objectives of the study.
6.Subjects with complete cancer remission less than 3 years prior to the date of screening.
7.Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; except those that are considered etiology of said indication.
8.Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
9.Subjects who are on anti-depressants, anti-psychotics.
10.Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
11.Subjects who have participated in any clinical study within 3 months from the date of enrolment.
12.Females who are pregnant or lactating or planning to become pregnant during the study period.
13.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
14.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Fasting Blood Glucose Levels: Improvement by 10% from baseline <br/ ><br>2.HbA1C: Improvement by 10% from baseline <br/ ><br>3.Diabetes Quality of Life Brief Clinical Inventory Questionnaire: Total Score of â?¤49 by end of study <br/ ><br>4.IP Feedback Questionnaire (IPFBQ): Total Score of â?¥20.Timepoint: 1.Fasting Blood Glucose Levels: Day 1, Day 90 <br/ ><br>2.HbA1C : Day 1,Day 90 <br/ ><br>3.Diabetes Quality of Life Brief Clinical Inventory Questionnaire: Day 1, Day 45, Day 90 <br/ ><br>4.IP Feedback Questionnaire (IPFBQ): Day 90 <br/ ><br>
- Secondary Outcome Measures
Name Time Method oneTimepoint: None