| CTRI Number |
CTRI/2022/07/043880 [Registered on: 08/07/2022] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on "Simpl" - A nutritional powdered supplement to control blood sugar levels in adults (diabetes) |
|
Scientific Title of Study
|
An Open Label, Prospective, Non-Randomised, Non-Comparative, Single Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Simpl†of Essen Fooddies India Pvt. Ltd as a Nutritional Supplement in Adults with Diabetes Mellitus Type II |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/DM2/061/20 Version 01 03May22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
#180/109, G1 & G2, RR Villa,
Rangarajapuram Main Road,
Kodambakkam
Chennai
TAMIL NADU
600034
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
#180/109, G1 & G2, RR Villa,
Rangarajapuram Main Road,
Kodambakkam
TAMIL NADU
600034
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
#180/109, G1 & G2, RR Villa,
Rangarajapuram Main Road,
Kodambakkam
TAMIL NADU
600034
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| Essen Fooddies India Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Essen Fooddies India Pvt Ltd |
| Address |
KINFRA Park, Kakkancherry
Malappuram 673635,
Kerala, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
#180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
Chennai – 600024. Tamil Nadu. India.
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VT Sriraam |
Raam Clinic |
Department of General/Family Medicine
Room No 7, #180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None. Single Arm Study |
None. Single Arm Study |
| Intervention |
Simpl |
Route of Administration : Oral
Formulation : Powdered Nutritional Formulation
Dose : 40g (4 scoops) in 150ml luke warm water
Dosage : OD for 3 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Fasting Blood Glucose Levels: Improvement by 10% from baseline
2. HbA1C: Improvement by 10% from baseline
3. Diabetes Quality of Life Brief Clinical Inventory Questionnaire: Total Score of ≤49 by end of study
4. IP Feedback Questionnaire (IPFBQ): Total Score of ≥20. |
1. Fasting Blood Glucose Levels: Day 1, Day 90
2. HbA1C : Day 1,Day 90
3. Diabetes Quality of Life Brief Clinical Inventory Questionnaire: Day 1, Day 45, Day 90
4. IP Feedback Questionnaire (IPFBQ): Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "53"
Final Enrollment numbers achieved (India)="53" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/07/2022 |
| Date of Study Completion (India) |
05/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None. Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Design : Open Label, Prospective, Non-Randomised,
Non-Comparative, Single Arm Clinical Study
Indication : Diabetes Mellitus Type II
Investigational Product Details
Name : SIMPL
Route of Administration : Oral
Formulation : Powdered Nutritional Formulation
Dose : 40g (4 scoops) in 150ml luke warm water
Dosage : OD for 3 months
Subject Population : Adult subjects between 30 and 65 years (both ages
and all sexes inclusive) with history of Diabetes Mellitus Type II without
complications
Treatment Arms : One. Non Comparative Single Arm
Study
Number of Subjects : 50 Subjects
Efficacy Assessments:
1. Fasting Blood Glucose : Day 1, Day 90
2. HbA1C : Day 1, Day 90
3. Diabetes Quality of Life Brief Clinical Inventory Questionnaire
: Day 1, Day 45, Day 90
4. IP Feedback Questionnaire : Day 90
Safety Assessments:
1. Clinical Safety : CBC, Serum Biochemistry
2. Monitoring of Adverse Events
Background of the study: Diabetes
mellitus is characterized by high blood glucose level with typical
manifestations of thirst, polyuria, polydipsia, and weight loss. It is caused
by defects in insulin-mediated signal pathways, resulting in decreased glucose
transportation from blood into muscle and fat cells. The major risk is vascular
injury leading to heart disease, which is accelerated by increased lipid levels
and hypertension.
Oral nutritional supplements can be prescribed to supply one or more
nutrient deï¬ciencies and restore the proper development and function of the body. The aim of such
products is to supplement everyday diet with nutrients in an effort to elevate
the health status in people with diabetes mellitus type II
Purpose of the Study : Simpl is a nutritional supplement by Essen Fooddies India Pvt. Ltd. with
nutrients that are essential to improve the nutritional state of adults,
specifically those with Type II Diabetes Mellitus. It helps in reducing blood
sugar levels, improving immunity and heart health. |