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CTRI Number  CTRI/2020/03/023947 [Registered on: 13/03/2020] Trial Registered Prospectively
Last Modified On: 11/03/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of CUQ1720 on blood glucose level after the food on healthy volunteers and diabetes patients 
Scientific Title of Study   A randomized, double-blind, placebo-controlled, clinical study to evaluate the effect CUQ1720 on the postprandial response in healthy subjects and as an adjuvant to metformin in diabetic subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Balachandra G 
Designation  Principal Investigator 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of General Medicine BGS Global Institute of Medical Sciences #67, BGS health and Education city, Uttarahalli road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone    
Fax    
Email  drbalachandrag777@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd 
Address  #9, 1st Floor, Mythri Legacy, Chelekere Main Road,Kalyan Nagar

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd 
Address  #9, 1st Floor, Mythri Legacy, Chelekere Main Road,Kalyan Nagar

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
Akay Flavours and Aromatics Private Limited ,Malaidamthuruthu P.O Ernakulam Kerala, India.  
 
Primary Sponsor  
Name  Akay Flavours and Aromatics Private Limited 
Address  Malaidamthuruthu P.O, Ernakulam,Kerala, India 
Type of Sponsor  Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Balachandra G  BGS Global Institute of Medical Sciences  #67, Department of General Medicine, 4th Floor, Uttarahalli road,Kengeri
Bangalore
KARNATAKA 		 984511559

drbalachandrag777@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Divakars Speciality Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  In fasting condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CUQ1720  Oral administration of 400mg CUQ1720 capsules along with metformin twice a day for 28 days in Diabetes Subjects 
Intervention  CUQ1720  Oral administration of CUQ1720 400mg capsules twice a day for 28 days in healthy volunteers 
Comparator Agent  Placebo  Oral administration of 400mg Placebo capsules along with metformin twice a day for 28 days in Diabetes Subjects 
Comparator Agent  Placebo  Oral administration of 400mg Placebo capsules twice a day for 28 days in healthy volunteers 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. BMI of 18-30 kg/m2  
 
ExclusionCriteria 
Details  For Healthy Subjects
1. Fasting Blood Sugar < 110 mg/dl
2. Hb1Ac less than 5.7 %

For diabetic Subjects

1. Fasting Blood Sugar ≥ 120 to ≤ 150 mg/dl
2. Hb1Ac: Greater than 6.5 %
3. Subjects on metformin 500 mg, twice a day, since past 3 months
4. Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test at screening
5. Subject willing to adhere with their routine diet, physical activity, and general lifestyle throughout the study
6. Must be willing and able to give informed consent and comply with the study procedures. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in post prandial Blood sugar level   Day 0, Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Bio markers, Questionnaire based assessments and over all safety of the Subjects  Day 0, Day 28 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/03/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   "None Yet" 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a randomized (1:1:1:1), double-blind, four arm, placebo-controlled clinical study. Healthy and diabetic subjects meeting all inclusion and exclusion criteria will be enrolled in the study after signing a written informed consent. The subjects will be categorized as healthy and diabetic according to their fasting blood sugar and Hb1Ac levels.Subjects will be requested to undergo overnight fasting for at least 10 hours before each visit and to maintain their typical diet, physical activity, and general lifestyle throughout the study. The subjects post-prandial blood sugar testing will be done at defined time intervels, after consumption of standard breakfast. Efficacy of the product will be established based on post prandial results, bio marker assessments and based on the Questionnaire based assessments. The safety of the subjects also will be evaluated. 
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