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CTRI Number  CTRI/2020/11/028809 [Registered on: 02/11/2020] Trial Registered Prospectively
Last Modified On: 21/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   AYURVEDA MANAGEMENT OF PREDIABETES 
Scientific Title of Study   "EFFICACY OF AYURVEDA TREATMENT PROTOCOL IN THE MANAGEMENT OF PREDIABETES- A RANDOMIZED CONTROLLED CLINICAL TRIAL" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SUMAN KHANAL 
Designation  PG Scholar 
Affiliation  KAHERs Shri BM Kankanwadi Ayurveda Mahavidhyalaya 
Address  KLE Ayurveda Hospital and Medical Research Centre, Department of Kayachikitsa, OPD Room no.6:Shahpur, Belgaum-03

Belgaum
KARNATAKA
590003
India 
Phone  9170745835  
Fax  08312424157  
Email  suman33kk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SUKETHA KUMARI 
Designation  Reader 
Affiliation  KAHERs Shri BM Kankanwadi Ayurveda Mahavidhyalaya 
Address  KLE Ayurveda Hospital and Medical Research Centre, Department of Kayachikitsa, OPD Room no.6:Shahpur, Belgaum-03

Belgaum
KARNATAKA
590003
India 
Phone  9483637757  
Fax  08312424157  
Email  sukethak.kaher@kleayurworld.edu.in  
 
Details of Contact Person
Public Query  
Name  SUKETHA KUMARI 
Designation  Reader 
Affiliation  KAHERs Shri BM Kankanwadi Ayurveda Mahavidhyalaya 
Address  KLE Ayurveda Hospital and Medical Research Centre, Department of Kayachikitsa, OPD Room no.6:Shahpur, Belgaum-03

Belgaum
KARNATAKA
590003
India 
Phone  9483637757  
Fax  08312424157  
Email  sukethak.kaher@kleayurworld.edu.in  
 
Source of Monetary or Material Support  
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH OWNED SHRI BM KANKANWADI AYURVEDA MAHAVIDHYALAYA AND KLE AYURVEDA HOSPITAL 
 
Primary Sponsor  
Name  KAHERs Shri BMK AYURVEDA MAHAVIDHYALAYA Pg Studies Hospital and Research Centre 
Address  Shahpur, Belgavi 590003 
Type of Sponsor  Private medical college 
 
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 Suman Khanal  KLE Ayurveda Hosital and Medical Research Center (OPD No.3 & 6 & IPD)  Shahpur, Belgaum 590003
Belgaum
KARNATAKA 		 9170745835
08312424157
suman33kk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E70-E88||Metabolic disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Placebo  Placebo of nutrient supplement with Standard Prediabetic Care 
Comparator Agent  Triphala Lauha Churna  Triphala Lauha Churna 3gm with Warm Water for 90 days along with Ayurveda dietary and Yogic Interventions 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Both gender patients attending the OPD & IPD of Shri.BMK Ayurveda Mahavidyalaya, Post Graduate Studies and Research Centre, Shahapur, Belagavi will be screened without bias of social, economic, educational, or religious status.
2. Patients aged between 18 - 70 yrs.
3. Patients fulfilling the diagnostic criteria of will be included for the study.
4.Patients willing to participate with written consent.
 
 
ExclusionCriteria 
Details  1. Cardiovascular and cerebrovascular events
(cerebrovascular accident in past 6 months, history of myocardial infarction or heart failure; severe organic heart disease; aneurysm of a main artery or dissecting aneurysm; specific angina; type II degree atrioventricular block; sick sinus syndrome)
2. Endocrine disease, such as hyperthyroidism.
3. Auto allergic disease, cancer or other serious or potentially fatal illness.
4. Pregnancy, preparation for pregnancy or active lactation in women.
5. Patients with mental illness or those who are uncooperative.
6. Refusal to provide consent for the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proposed Ayurveda treatment protocol is effective in prevention of disease progression in prediabetic subjects.  0, 30days, 60 days, 90days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  0,30,60,90 Days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/12/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study is aimed to Evaluate the efficacy of Ayurveda System protocol  which includes the Intervention drug Triphala Lauha Churna along with Yoga and Diet regimen as described in Ayurveda Classics which was compared with Standard prediabetic care group. No any PG synopsis has been done regarding the topic and drug is also new for the study in diabetes prevention. Thus this holistic approach gives the uniqueness of the study which is expected to prevent disease progression in Pre Diabetic Subjects. 
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