FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/05/008535 [Registered on: 11/05/2017] Trial Registered Prospectively
Last Modified On: 02/08/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of herbal drugs on blood sugar level 
Scientific Title of Study   Control of Glycemic Variability using a polyherbal: A randomized placebo controlled study of whole herb formulations. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alben Sigamani 
Designation  Group Head Clinical Research 
Affiliation  Narayana Hrudayalaya Hospital 
Address  1st Floor, B Block, Narayana Health City, Bommasandra Industrial Area

Bangalore
KARNATAKA
560099
India 
Phone  8884431444  
Fax  08884431444  
Email  alben.sigamani.dr@nhhospitals.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjaya Chauhan 
Designation  Clinical Research Associate 
Affiliation   
Address  Organic India Private Limited – R&D 8th Floor, A Block, Mazumdar Shaw Cancer Centre Narayana Health City, Bommasandra Industrial Area

Bangalore
KARNATAKA
560099
India 
Phone  9611252350  
Fax    
Email  drsanjayachauhan49@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sindhu N 
Designation  Co-Investigator 
Affiliation  Organic India 
Address  Organic India Private Limited – R&D 8th Floor, A Block, Mazumdar Shaw Cancer Centre Narayana Health City, Bommasandra Industrial Area

Bangalore
KARNATAKA
560099
India 
Phone  9902643747  
Fax    
Email  reddysindhu993@gmail.com  
 
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  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alben Siagamani  Narayana Hrudayala Limited Mazumdar Shaw Medical Centre   Department of Clinical Research, 6st Floor, B Block, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA Bangalore KARNATAKA
Bangalore
KARNATAKA 		 8884431444

alben.sigamani.dr@nhhospitals.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Medical Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Diabetes Mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo Inert capsule  Inert similar looking capsule. 
Intervention  Poly herbal capsule   Sugar balance® (SB) contains 3 whole herbs, Coccinia indica, Bougainvillea spectabilis and Madagascar periwinkle or sadabahar. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adult males and non-pregnant females aged ≥18 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 defined as no caloric intake for at least 8 hours, AND
2.Glycosylated haemoglobin (A1C) ≥ 6 %. The test should be performed in a laboratory using a method that is NABL certified and standardized within last 3 months.
 
 
ExclusionCriteria 
Details  Any one of the following
1.Patients on Insulin therapy.
2.Any history suggestive of micro vascular or macro vascular disease – coronary artery disease, stroke, peripheral artery disease or diabetes related retinal changes.
3.Women in child bearing age unable to practice any form of contraception
4.Patients with diagnosis of Anemia (Hb<11 g/dl in Female and <13 g/dl in Male)
5.Impaired renal function; eGFR<60mls/min/1.73m2.
6.Known history of any chronic illness taking regular pharmacological agents.
7.Blood pressure fluctuations exceeding 20mmHg on 2 subsequent clinic visits or known history of hypotension or bradycardia in last 6 months or taking 3 or more antihypertensive medications regularly in the last 6 weeks
8.Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy
9.Current or former employees of organic India or any potential conflict of interest in participation
10.Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
11.Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To demonstrate that the difference in mean amplitude glycemic excursions among patients receiving polyherbal medication will be less than 1mmol/dL or 18mg/dL for a sampling frequency: 1 every 15 minutes over 10 days  10 days 
 
Secondary Outcome  
Outcome  TimePoints 
Mean estimated glycated hemoglobin difference   10 days 
Number of hypoglycemia episodes   10 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2017 
Date of Study Completion (India) 01/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
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   The aim of this study is to gain insight into control of glycemic variability in impaired glucose tolerance and early type 2 diabetes using combination of 3 whole herbs Coccinia indica, Bougainvillea spectabilis and Madagascar periwinkle.
Glycemic variability refers to swings in blood glucose level. It plays important role in the development of diabetic micro- and macrovascular complications, hypoglycemic unawareness and it may be associated with an increased risk of both hypo- and hyperglycemic excursions. We hope to reduce the gylcemic variability with herbal drugs.
 
Close