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CTRI Number  CTRI/2023/09/058149 [Registered on: 29/09/2023] Trial Registered Prospectively
Last Modified On: 10/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Flavinergy (extract of Black-Thai Ginger) on metabolic health of overweight adults 
Scientific Title of Study   A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of Flavinergy on metabolic health of overweight adults. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Santosh Saklecha 
Designation  Principal Investigator 
Affiliation  Santosh Hospital 
Address  6/1, Promenade Road, Behind Coles Park, Bengaluru.

Bangalore
KARNATAKA
560005
India 
Phone  9845306703  
Fax    
Email  ssaklecha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Satish G 
Designation  Vice President 
Affiliation  Sami Sabinsa Group Limited 
Address  19/1 & 19/2, I Main, II Phase, Peenya Industrial Area Bangalore.

Bangalore
KARNATAKA
560058
India 
Phone  08068527777  
Fax    
Email  satish.g@clinworld.net  
 
Details of Contact Person
Public Query  
Name  Satish G 
Designation  Vice President 
Affiliation  Sami Sabinsa Group Limited 
Address  19/1 & 19/2, I Main, II Phase, Peenya Industrial Area Bangalore.


KARNATAKA
560058
India 
Phone  08068527777  
Fax    
Email  satish.g@clinworld.net  
 
Source of Monetary or Material Support  
Sami Sabinsa Group Limited 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area Bangalore - 560 058, Karnataka, India  
 
Primary Sponsor  
Name  Sam Sabinsa Group Limited 
Address  19/1 & 19/2, I Main, II Phase, Peenya Industrial Area Bangalore - 560 058, Karnataka, India 
Type of Sponsor  Other [Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements.] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Santosh Saklecha  Santosh Hospital  Department of General Medicine, 6/1, Promenade Road, Behind Coles Park, Bengaluru.
Bangalore
KARNATAKA 		 09845306703

ssaklecha@gmail.com 
Dr Meghana Murthy  Vagus Super Speciality Hospital  Department of General Medicine, Ground Floor, 6,7 & 8, 18th Cross 4th Main, Malleshwram, Bangalore
Bangalore
KARNATAKA 		 07259214727

meggydoc@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Santosh Hospital Institutional Ethics Committee  Approved 
Santosh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Overweight adults with BMI between 25 to 29.99 kg/m2. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Flavinergy  Extract of Black- Thai Ginger in capsule form with dose of 150 mg twice a day after breakfast and dinner for 90 days. 
Comparator Agent  Placebo  Microcrystalline Cellulose in capsule form with a dose of 150mg twice a day after breakfast and dinner for 90 days.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Participants should be willing to give signed written informed consent.
2. Participants should be willing to comply with the requirements of the trial/study.
3. Male and Female participants aged between 25-55 years.
4. Subjects whose BMI lie between 25 to 29.99 kg/m2.
5. Subjects who meet any of the two criteria to be included in the study:
a) Triglyceride more than 160mg/dl
b) HDL Cholesterol less than 50 mg/dl in women and less than 40 mg/dl in men
c) LDL Cholesterol more than 120 mg/dl
d) Serum Total Cholesterol more than 200 mg/dl
6) Blood Pressure more than 130/90 mmHg without medication.
7) Fasting Blood Glucose more than 120 mg/dl without medication.
8) Ability to swallow and retain oral medications as per the protocol. 
 
ExclusionCriteria 
Details  1. Subjects who are taking any anti-obesity medication or weight reduction treatments including the herbal preparations.
2. Subjects with abnormal thyroid profile.
3. History of surgical procedures for weight loss.
4. Use of supplements, special diet or functional foods affecting carbohydrate and lipid metabolism during the study period.
5. History of chronic smoking and alcoholism.
6. Pregnant, lactating women and those not willing to follow a reliable and effective contraceptive measure during the study period. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Change in Visceral fat area.
2. Change in lipid profile 		 1. Change in Visceral fat area from day-1 to day-90.
2. Change in lipid profile from screening to day-90. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in Body weight & BMI.
2. Mean change in Anthropometric measurement
3. Change in Sub-cutaneous fat area and Total fat area.
4. Improvement in Blood Pressure and Fasting Blood Glucose.
5. Safety is determined based on the tolerance to Flavinergy without any incidence of adverse events. Study compliance without drop-outs. No adverse change in complete blood count, urine routine and microscopic blood biochemistry, and incidence of any adverse events during the study period in both the arms. 		 1. Screening to Day-90
2. Screening to Day-90
3. Day-1 to Day-90
4. Screening to Day-90
5. Day-1 to Day-90 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   11/10/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study involves 80 subjects randomized in two arms and will receive 90 days of treatment and telephonic follow-up after 7 days following the last visit. Participant will be randomized to receive either test product (Flavinergy- extract of Black- Thai Ginger)- 150mg or placebo (Microcrystalline cellulose) twice a day. Specific biomarkers like lipid profile, fasting blood sugar will be measure along with CT scan to measure the Sub-cutaneous Fat Area, Visceral Fat Area and Total Fat Area during the study period. The final statistical analysis and study report will be complied at the end of the study period. 
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