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CTRI Number  CTRI/2012/05/002678 [Registered on: 21/05/2012] Trial Registered Retrospectively
Last Modified On: 25/08/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Safety and efficacy of herbal supplements in prediabetic and mild to moderate hyperlipidemic subjects. 
Scientific Title of Study   Efficacy and safety study of herbal supplements (SR-L-01, SR-B-01 and SI-S-01) in the management of prediabetes and mild to moderate hyperlipidemia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
OL-S-OB-LP/03-12 Ver 01 25/03/2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K R Raveendra MD 
Designation  Physician & Cardiologist 
Affiliation  Karnataka University 
Address  Srinivasa Clinic & Diabetic Care Center, Girinagar,

Bangalore
KARNATAKA
560050
India 
Phone  919448134587  
Fax    
Email  drkrraveendra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr H N Shivaprasad PhD Pharma 
Designation  General Manager – Research & Technical Affairs 
Affiliation  Olive Lifesciences Pvt. Ltd. 
Address  2203, Pragathi, 16th D Cross, 8th Main, SahakarNagar

Bangalore
KARNATAKA
560 092
India 
Phone  8971489704  
Fax    
Email  shiv@olivelifesciences.com  
 
Details of Contact Person
Public Query  
Name  Dr H N Shivaprasad PhD Pharma 
Designation  General Manager – Research & Technical Affairs 
Affiliation   
Address  2203, Pragathi, 16th D Cross, 8th Main, SahakarNagar

Bangalore
KARNATAKA
560 092
India 
Phone  8971489704  
Fax    
Email  shiv@olivelifesciences.com  
 
Source of Monetary or Material Support  
Olive Lifesciences Pvt Ltd  
 
Primary Sponsor  
Name  Olive Lifesciences Pvt Ltd 
Address  2203, Pragathi, 16th D Cross, 8th Main, SahakarNagar, Bangalore - 560 092  
Type of Sponsor  Other [Herbal Extract and Supplement Industry] 
 
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 K R Raveendra   Srinivasa Clinic & Diabetic Care Center  Division of Medicine, Diabetic Care Department, Number 197, Girinagar,Bangalore 560050 India
Bangalore
KARNATAKA 		 9448134587

drkrraveendra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Srinagar Nursing Home, Bangalore India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Prediabetes and mild to moderate hyperlipidemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  2 capsules BID orally, for 6 weeks 
Intervention  SI-S-01  2 capsules BID orally, for 6 weeks 
Intervention  SR-B-01  2 capsules BID orally, for 6 weeks 
Intervention  SR-L-01  2 capsules BID orally,for 6 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.As per ATP III guidelines: Baseline LDL ranging 160-189 mg/dL, TC >200 mg/dL and with no or one of the below risk factors
•Current cigarette smoking
•Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years)
•Hypertension (BP ≥140/90 mmHg or on antihypertensive medication)
•Low HDL-C (<40 mg/dL)
•Age (men ≥ 40 years; women ≥ 40 years)
2.Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of ≥140 to ≤ 200 mg/dL)
3.Impaired fasting sugar (FBS levels in the range of ≥ 100 to ≤125 mg/dL)
4.Being mentally competent and able to understand all study requirements and sign the informed consent form 
 
ExclusionCriteria 
Details  1.Patients with severe liver, renal, cardiac or brain diseases
2.Pregnant or lactating women or women of childbearing potential whom are not practicing a reliable form of birth control (either with IUD or with stable usage of oral contraceptives)
3.Unable to complete follow up
4.Subjects on any medication that would affect evaluation like Statins
5.Allergic to any medication
6.With a history of alcohol and/or drug abuse
 
 
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 
Change in FBS,OGTT, and PPBS levels
Change in LDL, VLDL, HDL and TC levels 		 3 and 6 weeks
3 and 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Safety and tolerability  6 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/04/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="12" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomized, double blind, parallel group, placebo controlled trial determining the safety and efficacy of herbal supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) in the management of prediabetes and mild to moderate hyperlipidemia. The primary outcome measures will be reduction in FBS, OGTT, PPBS, LDL, VLDL, HDL and TC at 6 weeks. The secondary outcomes will be Safety and tolerability at 6 weeks. 
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