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
|
|
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
|
|
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). |