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CTRI Number  CTRI/2019/04/018494 [Registered on: 08/04/2019] Trial Registered Prospectively
Last Modified On: 13/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management of Type 2 Diabetes Mellitus through Ayurveda 
Scientific Title of Study   A Field Study on Ayurvedic Management of Type 2 Diabetes Mellitus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nagaratna R 
Designation  Medical Director 
Affiliation  Vivekananda Yoga Anusandhana Samsthana(VYASA) 
Address  VYASA Arogyadhama Hospital, Prashanthi Kutiram, Kalluballu Post,Jigani, Anekal Taluq, Bengaluru
PRASHANTHI KUTIRAM, KALUBALU POST,JIGANI, ANEKAL TALUQ, BENGALURU-560105
Bangalore Rural
KARNATAKA
560105
India 
Phone  080-22639953  
Fax    
Email  rnagaratna@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nagaratna R 
Designation  Medical Director 
Affiliation  Vivekananda Yoga Anusandhana Samsthana(VYASA) 
Address  VYASA Arogyadhama Hospital, Prashanthi Kutiram, Kalluballu Post,Jigani, Anekal Taluq, Bengaluru
PRASHANTHI KUTIRAM, KALUBALU POST,JIGANI, ANEKAL TALUQ, BENGALURU-560105
Bangalore Rural
KARNATAKA
560105
India 
Phone  080-22639953  
Fax    
Email  rnagaratna@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Singh 
Designation  Resident Medical Officer 
Affiliation  Vivekananda Yoga Anusandhana Samsthana(VYASA) 
Address  VYASA Arogyadhama Hospital, Prashanthi Kutiram, Kalluballu Post,Jigani, Anekal Taluq, Bengaluru
PRASHANTHI KUTIRAM, KALUBALU POST,JIGANI, ANEKAL TALUQ, BENGALURU-560105
Bangalore Rural
KARNATAKA
560105
India 
Phone  080-22639953  
Fax    
Email  dramits90@gmail.com  
 
Source of Monetary or Material Support  
Jivanti Welfare and Charitable Trust 
 
Primary Sponsor  
Name  Jivanti Welfare and Charitable Trust 
Address  8/3, Asaf Ali Road, New Delhi-110002 
Type of Sponsor  Other [Trust] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sreedhar P  Bangalore   VYASA, Prashanthi Kutiram Kallubollu post Vaddera Manchanahalli Anekal Tq. Bangalore - 560105
Bangalore Rural
KARNATAKA 
9632648161

YOGAATSREEDHAR@GMAIL.COM 
Ms R H Lata  Bhopal  Yoga Clinic,315 Mini Market, opposite Cenepolis Aashima Mall, Hosangabad Road Bhopal
Bhopal
MADHYA PRADESH 
9425126644

latavk_2003@yahoo.co.in 
Dr Mamata Mishra  Kalyan West  Dirghayuh Treatment centre, Pranit bldg., shop 15, Near Sai Chowk, Khadakpada, KALYAN west 421301
Thane
MAHARASHTRA 
8879229490

mamtamishrapurohit@gmail.com 
Dr Vetrivendan  Salem  Vasista clinic, Triveni gardens, Gorimedu, Salem Tamil Nadu
Salem
TAMIL NADU 
9443207000

Vetriyoga@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, SVYASA, Bengaluru  Approved 
Institutional Ethics Committee, SVYASA, Bengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayurveda drug  AYUSH-82 extract tablet 4 tablets per day : 2 in the morning and 2 in the evening. Orally taken. Tablets will be taken for 12 months.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  With or Without hypertension and obesity
With or Without Oral Hypo-glycaemic drugs [Any OHA]
HbA1c >5.8% 
 
ExclusionCriteria 
Details  1.Type 2 Diabetes mellitus patients with major or minor cardiac, ophthalmic, renal complications.
2.Type 2 Diabetes mellitus patients with major neurological complications.
3.Type 2 Diabetes mellitus patients with associated conditions such as uncontrolled hypertension (persistent BP > 180/ 100 mm of Hg after two consecutive recordings and also by checking from their earlier medical records).
4.Type 2 Diabetes mellitus patients with severe obesity [BMI ≥ 40 kg/m2].
5.Type 2 Diabetes mellitus patients with history of a major/ minor surgery in the past 3 months.
6.Type 2 Diabetes mellitus patients with history of tuberculosis within past 3 years.
7.Type 2 Diabetes mellitus patients with History of head injury, or psychiatric disorder in the past
8.Type 2 Diabetes mellitus patients in Pregnancy and lactation.
9.Type 2 Diabetes mellitus patients who are taking Homeopathy, Ayurveda, Unani & Siddha systems of medicine
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
FBS, HbA1C  0,3,6,12 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Liver function test, Kidney Function Test, Lipid Profile  0,12 Months 
 
Target Sample Size   Total Sample Size="6000"
Sample Size from India="6000" 
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)   10/04/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Diabetes has been on the rise in India. There is now more than ever, a need to have a comprehensive cost-effective mass health care strategy to address the disease and its associated complication. Apart from the management of Diabetes, it also becomes vital to screen and identify the high-risk population and put in place appropriate interventions / strategies to prevent progression to diabetes mellitus.

VYASA is a yoga research foundation established in 1986 for education, research and propagation of all applications of Yoga with a vision to make Yoga a socially relevant science.

S-VYASA (a deemed University under section 3 of UGC act 1956), a NAAC A+ accredited University established in 2002 is an off shoot of VYASA.As a part of its mission, VYASA has scientifically validated Yoga practices and has been able to scientifically develop and administer personalised disease specific Yoga modules. In 2016, an initiative of VYASA was funded by the Ministry of AYUSH and conducted by IYA (Indian Yoga Association) as a nationwide randomised controlled research study of implementing Yoga based life style change program – Niyantritha Madhumeha Bharatha [NMB] to treat and prevent incidence of Type 2 Diabetes mellitus.

Under the national scheme NMB, 2,40,968 adults were screened for Diabetes mellitus across the country in both urban and rural areas of India. Under the same scheme those diagnosed Type 2 Diabetes mellitus patients and those with high-risk were treated with Yoga and followed up for 3 months to understand the efficacy of Yoga.

In the present study we propose to study the efficacy of action of AYUSH-82 extract tablet in management of Type 2 Diabetes mellitus patients. Standardized ayurvedic formulation, AYUSH-82 extract tablet will be administered as intervention. The study is funded under the CSR (Corporate Social Responsibility) program of Jivanti Welfare and Charitable Trust (JWCT).

 
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