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CTRI Number  CTRI/2019/06/019855 [Registered on: 25/06/2019] Trial Registered Prospectively
Last Modified On: 30/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Study on Nichi Glucan to treat Diabetes with/without High Cholesterol and Lipid Levels. 
Scientific Title of Study   A Double Blind, Prospective, Randomised, Comparative, Placebo Controlled, Two Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Nichi Glucan in the Management of Adult Subjects with Diabetes Mellitus Type II with/without Dyslipidemia. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
AHC/DM2-DLP/050/19 Version No 02 Dated 04-Oct-19  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr VT Sriraam 
Designation  Chief Medical Research Coordinator 
Affiliation  Aurous HealthCare R & D India Private Limited 
Address  180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai - 600024.

Chennai
TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Details of Contact Person
Scientific Query  
Name  Dr VT Sriraam 
Designation  Chief Medical Research Coordinator 
Affiliation  Aurous HealthCare R & D India Private Limited 
Address  180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai - 600024.


TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Details of Contact Person
Public Query  
Name  Dr VT Sriraam 
Designation  Chief Medical Research Coordinator 
Affiliation  Aurous HealthCare R & D India Private Limited 
Address  180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai - 600024.


TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Source of Monetary or Material Support  
Enerflo Singapore Pvt. Ltd., #21-07 International Plaza 10, Anson Road, Singapore - 079903  
GN Corporation Co. Ltd. 3-8 Wakamatsu-Cho, Kofu, 400-0866, Yamanashi Prefecture, Japan.  
 
Primary Sponsor  
Name  Enerflo Singapore Pvt Ltd  
Address  #21-07 International Plaza 10, Anson Road, Singapore - 079903 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Aurous HealthCare Research and Development India Private Limited  180/109, G1 and G2, RR Villa, Rangarajapuram Main Road, Kodambakkam, Chennai - 600024 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr PGKirubakaran  Akshaya Clinic  Room No 1 95/43 Gowdiya Mutt Road, Royapettah, Chennai 600014
Chennai
TAMIL NADU 		 9884098845

pgkriba@yahoo.com 
Dr R Ravindranath  Diabetes and Heart Care Clinic  Room No. 1 H2, Turnbulls Road, I Corss St, Nandanam, Chennai 600035
Chennai
TAMIL NADU 		 9445114464

ravidiacare@yahoo.com 
Dr KS Pradeep  Diacheck Sugar Control Clinic  Room No 1 #30, Sait Colony, First Street, Egmore, Chennai 600008
Chennai
TAMIL NADU 		 9940194266

drpradeep@bewellhospitals.in 
Dr Mohan  M.K. Nursing Home  Room No 1. Old No 46, New, No 24, Rathina Sabapathy St, Tondiarpet, Chennai - 600021 Tamil Nadu, India.
Chennai
TAMIL NADU 		 9884112461

drmohan_2000@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd )  Approved 
Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd )  Approved 
Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd )  Approved 
Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd )  Approved 
Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd )  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nichi Glucan  0.5 grams within 30 minute of each meal; TID for 3 months (90 days) 
Comparator Agent  Placebo  0.5 grams within 30 minute of each meal; TID for 3 months (90 days) 
 
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 sexes inclusive)
2. Subjects with history of Diabetes Mellitus Type II treated only by oral hypoglycaemic agents and/or insulin.
3. Subjects with Dyslipidemia to be analysed as cohort; having fasting triglyceride levels ≥200mg/dL and any one or all of the following
 Total cholesterol ≥ 250 mg/dL
 VLDL level of ≥ 40 mg/dL
 LDL levels of ≥129 mg/dL
 HDL level of ≤ 39 mg/dL
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 who are HIV Positive.
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 [eg, 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/CRMC are not eligible for enrolment in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. FBG: 70 - 125 mg/dL
2. PPBG: 140 - 199 mg/dL or 30% reduction from baseline
3. HbA1C: 5.7 - 6.4%
4. HbA1C: 5.7%
1. Triglycerides : 150mg/dL or 30% reduction from baseline
2. Total Cholesterol: 200mg/dL or 30% reduction from baseline
3. VLDL level 30 mg/dL or or 30% reduction from baseline value
4. LDL : 100mg/dL or 30% reduction from baseline value
5. HDL: ≥45 mg/dL or 30% reduction from baseline value  		 1. FBG: Day 1, 45, 90
2. PPBG: Day 1, 45, 90
3. HbA1C: Day 1, 45, 90
1. Triglycerides : Day 1, 45, 90
2. Total Cholesterol: Day 1, 45, 90
3. VLDL level Day 1, 45, 90
4. LDL : Day 1, 45, 90
5. HDL: Day 1, 45, 90 
 
Secondary Outcome  
Outcome  TimePoints 
1. Post Prandial Spike (1 hour post meal): 30% reduction from baseline value by end of study.
2. Diabetes Quality of Life Brief Clinical Inventory Questionnaire: Total Score of ≤49 by end of study
3. Safety Monitoring: Adverse events frequency and severity; Clinically abnormal safety parameters 		 1. Post Prandial Spike (1 hour post meal): : Day 1, 45, 90
2. Diabetes Quality of Life Brief Clinical Inventory Questionnaire: : Day 1, 45, 90
3. Safety Monitoring: : Day 1, 45, 90
 
 
Target Sample Size   Total Sample Size="222"
Sample Size from India="222" 
Final Enrollment numbers achieved (Total)= "157"
Final Enrollment numbers achieved (India)="157" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/06/2019 
Date of Study Completion (India) 22/04/2020 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Study Design
A Double Blind, Prospective, Randomised, Comparative, Placebo Controlled, Two Arm Clinical Study

Study Population
Adult subjects between 30 and 65 years (both ages and all sexes inclusive) with history of diabetes mellitus type II with or without dyslipidemia.

Indication
Diabetes Mellitus Type II with or without dyslipidemia

Investigational Product  Test : Nichi Glucan
Comparator : Placebo

Dose/Dosage/ROA : 0.5 grams to be consumed thrice day, 30 minutes after breakfast, lunch and dinner. Dissolve the contents of the sachet in half a glass of water, stir well and consume. 

Treatment Duration
3 months (90 days)

Number of subjects
222 subjects.

Treatment Arm I : Nichi Glucan : 148 Subjects
Treatment Arm II: Placebo : 74 Subjects

Assessments for Diabetes mellitus type II
1. Fasting Blood Glucose
2. Post Prandial Blood Glucose (2 hours post meal)
3. HbA1C
4. Post Prandial Spike (1 hour post meal)
5. Quality of Life Questionnaire

Assessments for Dyslipidemia (analysed as cohort)
1. Triglycerides
2. Total Cholesterol
3. LDL
4. VLDL
5. HDL
 
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