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CTRI Number  CTRI/2016/11/007435 [Registered on: 04/11/2016] Trial Registered Prospectively
Last Modified On: 13/09/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of poly herbal compound for control of blood sugar in impaired glucose tolerance and early type 2 diabetes 
Scientific Title of Study   A Poly herbal for Control of Blood Sugar in Subjects With Impaired Glucose Tolerance and/or Early Type 2 Diabetes. A Randomized Placebo Controlled Study of a Poly herbal (Whole Herb Formulation)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NCT02866539  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Alben Sigamani 
Designation  Doctor 
Affiliation  Narayana Hrudayalaya Hospital 
Address  1st Floor, B Block, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA

Bangalore
KARNATAKA
560099
India 
Phone  8884431444  
Fax    
Email  alben.sigamani.dr@nhhospitals.org  
 
Details of Contact Person
Scientific Query  
Name  Alben Sigamani 
Designation  Doctor 
Affiliation  Narayana Hrudayalaya Hospital 
Address  1st Floor, B Block, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA

Bangalore
KARNATAKA
560099
India 
Phone  8884431444  
Fax    
Email  alben.sigamani.dr@nhhospitals.org  
 
Details of Contact Person
Public Query  
Name  Alben Sigamani 
Designation  Doctor 
Affiliation  Narayana Hrudayalaya Hospital 
Address  1st Floor, B Block, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA

Bangalore
KARNATAKA
560099
India 
Phone  8884431444  
Fax    
Email  alben.sigamani.dr@nhhospitals.org  
 
Source of Monetary or Material Support  
Organic India Private Limited – R&D 8th Floor, A Block, Mazumdar Shaw Cancer Centre Narayana Health City, Bommasandra Industrial Area Bangalore 560099, Karnataka State, INDIA 
 
Primary Sponsor  
Name  Organic India 
Address  Organic India Private Limited – R&D 8th Floor, A Block, Mazumdar Shaw Cancer Centre Narayana Health City, Bommasandra Industrial Area Bangalore 560099, Karnataka State, INDIA 
Type of Sponsor  Other [Herbal Supplement Manufacturer] 
 
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 Sandeep Kumar Gupta  KRM Hospital and Research Centre  3/92-93, Vijayant Khand, Gomti Nagar, Near Chinhut crossing
Lucknow
UTTAR PRADESH 		 7007208089

krmhrclko@gmail.com 
Dr Alben Sigamani  Narayana Hrudayala Limited Mazumdar Shaw Medical Centre  Department of Clinical Research, 1st Floor, B Block, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA 		 8884431444

alben.sigamani.dr@nhhospitals.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Narayana Health Academic Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 Diabetes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo Inert capsule  Inert similar looking capsule. All participant will be instructed to take 2 inert similar looking capsules twice daily at a fixed time for 6 months.  
Intervention  Poly herbal capsule  Sugar balance® (SB) contains 3 whole herbs, Coccinia indica, Bougainvillea spectabilis and Madagascar periwinkle or sadabahar. All participants will be instructed to take 2 capsules twice a day at a fixed time in the day for six months. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adult males and non-pregnant females aged ≥30 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) or diabetes and meeting one of the following criteria
1. Fasting Plasma Glucose ≥100 mg/dL, fasting is defined as no caloric intake for at least 8 h, OR
2. 2-h Post load Glucose ≥140 mg/dL during an OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water. OR
3. Glycosylated haemoglobin (A1C) ≥5.7%. The test should be performed in a laboratory using a method that is NABL certified and standardized. OR
4. In a patient with classic symptoms of hyperglycaemia or hyperglycaemic crisis, a random plasma glucose ≥200 mg/dL in the last 12 months.
 
 
ExclusionCriteria 
Details  Any one of the following
1. History of diabetes onset >12 months from date of randomization and/or on any oral hypoglycemic agents (other than metformin) or Insulin.
2. Any history suggestive of micro vascular or macro vascular disease
3. Women in child bearing age unable to practice any form of contraception
4. Impaired renal function; eGFR<60mls/min/1.73m2.
5. Known history of any chronic illness taking regular pharmacological agents.
6. Blood pressure fluctuations exceeding 10mmHg on 2 subsequent clinic visits or known history of hypotension or bradycardia in last 6 months or taking 2 or more antihypertensive medications regularly in the last 6 weeks
7. Current or former employees of organic India
8. Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
9. Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
The primary objective at 6 months is as follows
1. In patients with diabetes; a 0.5% reduction in baseline A1c and/or fasting plasma glucose below 125 mg/dl or 2 hour postprandial glucose 180 mg/dl
2. In those with pre-diabetes it will be achieving eugylcemic status measured as A1c 5.7% and/or fasting plasma glucose 100 mg/dl/
 		 The primary objective at 6 months is as follows
1. In patients with diabetes; a 0.5% reduction in baseline A1c and/or fasting plasma glucose below 125 mg/dl or 2 hour postprandial glucose 180 mg/dl
2. In those with pre-diabetes it will be achieving eugylcemic status measured as A1c 5.7% and/or fasting plasma glucose 100 mg/dl/
 
 
Secondary Outcome  
Outcome  TimePoints 
Number of diabetes patients with hypoglycemia as adverse events  1 months 
 
Target Sample Size
Modification(s)  		 Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "122"
Final Enrollment numbers achieved (India)="122" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/12/2016 
Date of Study Completion (India) 15/12/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   The Project Office Operations Committee will appoint members to a Publication Committee. This committee will create guidelines for publications related the study. We will publish the main manuscript under group authorship, with the roles of all investigators acknowledged in an appendix. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The aim of study is to control blood glucose in impaired glucose tolerance and early type 2 diabetes using combination of 3 whole herbs Coccinia indica, Bougainvillea spectabilis and Madagascar periwinkle. 
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