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CTRI Number  CTRI/2019/11/021992 [Registered on: 13/11/2019] Trial Registered Prospectively
Last Modified On: 01/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This is a multicenter study wherein the efficacy and safety of standardized 10% β –glucogallin Saberry (an extract of amla) will be studied against Metformin in newly diagnosed adult male or female patients with Type 2 Diabetes mellitus associated with abnormal amount of lipids in the blood. 
Scientific Title of Study   A Prospective, randomized, open-label, comparative study to evaluate the efficacy and safety of standardized 10% β –glucogallin (Saberry), an extract of Emblica officinalis against Metformin 500mg in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidemia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CPL/80/BGG_T2DM/I/JUN/19V1.009-SEP-19  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Balachandra 
Designation  Professor & Head of Department 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of General Medicine, Room No.67, BGS Health & Education City, Uttarahalli Road, Kengeri, Bengaluru, Karnataka.

Bangalore
KARNATAKA
560060
India 
Phone  09845111559  
Fax    
Email  drgbalachandra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kalpesh Shah 
Designation  Senior Vice President 
Affiliation  ClinWorld Private Limited 
Address  19/1 & 19/2, I Main,II Phase, Peenya Industrial Area, Bangalore, Karnataka.

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  kalpesh@clinworld.org  
 
Details of Contact Person
Public Query  
Name  Dr Kalpesh Shah 
Designation  Senior Vice President 
Affiliation  ClinWorld Private Limited 
Address  19/1 & 19/2, I Main,II Phase, Peenya Industrial Area, Bangalore, Karnataka.


KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  kalpesh@clinworld.org  
 
Source of Monetary or Material Support  
Sami Labs Limited 19/1 & 19/2,I Main,II Phase, Peenya Industrial Area, Bangalore.560058.  
 
Primary Sponsor  
Name  Sami Labs Limited 
Address  19/1 & 19/2, I Main,II Phase, Peenya Industrial Area, Bangalore,Karnataka. 560058.  
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  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr T V Devarajan   Apollo First Med Hospital  No.154, Poonamallee High Rd, New Bupathy Nagar, Kilpauk, Chennai, 600010, Tamil Nadu
Chennai
TAMIL NADU 		 09840083737

hilda.s@apollaari.com 
Dr G Balachandra  BGS Global Institute of Medical Sciences   Department of General Medicine, Room No. 67, BGS Health & Education City, Uttarahalli Road, Kengeri, Bengaluru-560060
Bangalore
KARNATAKA 		 09845111559

drgbalachandra@gmail.com 
Dr S Satyanarayana Murthy   Diabetes & Endocrine Centre, A Unit of Vijaya Super Speciality Hospital  Diabetes & Endocrine Centre, A Unit of Vijaya Super Speciality Hospital, Raghavacine Complex road, Pogathota, Nellore - 524001 AndraPradesh
Nellore
ANDHRA PRADESH 		 09849050063

projectspcr@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Divakars Speciality Hospital Ethics Committee (DSHEC)   Approved 
Institutional Ethics Committee-Bio Medical Research   Approved 
Vijaya Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E089||Diabetes mellitus due to underlying condition without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Metformin Hydrochloride (Obimet 500 mg Tablet)  One tablet once a day orally with breakfast for 90days.  
Intervention  Standardized 10% β –glucogallin (Saberry®) Tablet  Two tablets once a day orally after breakfast for 90 days. 
Intervention  Standardized 10% β –glucogallin (Saberry®) Tablet  Two tablets twice a day orally after breakfast & dinner for 90 days. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male and female of 30 to 65 years old inclusive of both.
2.Body Mass Index (BMI) range 27to 35 kg/m2.
3.Females with child bearing potential who agree to use barrier method of contraception throughout the study period.
4.Newly Diagnosed of Type 2 Diabetes (T2DM) and is drug naive with FBS>130 mg/dL; PPBS>210mg/dL; HbA1c>6.5%.
5.Lipid parameters: Total Cholesterol>200mg/dL,
Triglyceride>160 mg/dL, LDL>140 mg/dL.
6.Patients willing to follow suggested diet and a physical activity by the study doctor for a minimum of 30 min for 5 days in a week.
7.Patients must be willing to come for regular follow-up visits.
8.Willing to sign informed consent. 
 
ExclusionCriteria 
Details  1.Pregnant and lactating female and having the intention to be pregnant within next three months.
2.History of Smoking & Alcohol intake (within 3 months before screening).
3.Type 1 diabetes.
4.With chronic gastrointestinal diseases, severe immune deficiency, lactose intolerance.
5.Use of any lipid-lowering therapies in the past 3 months.
6.Patient with TG > 300 mg/dL, LDL > 200 mg/dL, Total cholesterol> 300 mg/dL FBS > 150 mg/dL and PPBS> 300 mg/dL.
7.Patients with HbA1C > 9.0 % (9.1% excluded)
8.Patient on antihypertensive medication.
9.Patient with history of clinically significant thyroid disorder (hypo or hyper), gastrointestinal, cardiovascular, haematological, hepatic (SGOT or SGPT levels > 3 Upper Limit of Normal), renal (serum creatinine ≥ 1.3 mg/dl), respiratory, active malignancy or genitourinary abnormalities or diseases.
10.A history of significant multiple and/or severe allergies or anaphylactic reactions.
11.Patient with known history of hypersensitivity to the investigational product.
12.Patient has participated in any clinical trial within last 3 months.
13.Any other condition which the Principal Investigator thinks may jeopardize the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Mean % percentage change in HbA1c from screening to final visit.
2. Mean change in fasting plasma glucose and post prandial plasma glucose from screening to final visit. 		 1. Mean % percentage change in HbA1c (Screening and Day90).
2. Mean change in fasting plasma glucose and post prandial plasma glucose (Screening,Day30,Day60 and Day90). 
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean change in Lipid Profile from screening to final visit.
2.To compare the mean change in HbA1c, fasting plasma glucose, post - prandial plasma glucose and lipid profile with 1gm/day & 2gm/day dose of Saberry® tablets.
3.Changes in weight and BMI.
4.Assessment of Adverse Events 		 1.Mean change in Lipid Profile(Screening, Day30,Day60 and Day90).
2.To compare the mean change in HbA1c, fasting plasma glucose, post - prandial plasma glucose with 1gm/day & 2gm/day dose of Saberry® tablets(Screening, Day30,
Day60 and Day90).
3.Changes in weight and BMI(Screening and Day90).
4.Assessment of Adverse Events(Day30,Day60 and Day90). 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)   12/11/2019 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Diabetes Mellitus is a major public health challenge of the twenty-first century. Increasing Levels of Urbanization, Industrialization and economic advancement adversely affect the biological and environmental risk factors for Diabetes and other non-communicable diseases. Unhealthy diet, physical inactivity and stress factors cause overweight and insulin resistance. This study entitled “A Prospective, randomized, open-label, comparative study to evaluate the efficacy and safety of standardized 10% β –glucogallin (Saberry), an extract of Emblica officinalis against Metformin 500mg in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidemia”.

All the parameters of assessment will be based on the signs and symptoms as mentioned in study criteria. Patients fulfilling the criteria will be selected and divided in three arms groups and followed by a filling of consent form in language best understood by them - first intervention arm as one capsule of Saberry once a day, second intervention arm as one capsule of  Saberry twice a day and third intervention arm as one tablet of Metformin once a day and depending on  randomization code patients will be receiving either Saberry or Metformin.

All the parameters will be assessed before and after treatment based on the specially prepared proforma, Appropriate test will be applied to the data outcome and discussion and conclusion will be made accordingly.

 
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