| CTRI Number |
CTRI/2019/03/018336 [Registered on: 29/03/2019] Trial Registered Prospectively |
| Last Modified On: |
21/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Management of Type 2 Diabetes Mellitus through Ayurveda |
|
Scientific Title of Study
|
A Two Arm, Randomized, controlled, double blinded Study on Ayurvedic management of Type-2 Diabetes |
| 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 |
| Address |
VYASA, Arogyadhama hospital, Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
08022639953 |
| Fax |
|
| Email |
rnagaratna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagaratna R |
| Designation |
Medical Director |
| Affiliation |
Vivekananda Yoga Anusandhana Samsthana |
| Address |
VYASA, Arogyadhama hospital, Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
08022639953 |
| Fax |
|
| Email |
rnagaratna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Singh |
| Designation |
Resident Medical Officer |
| Affiliation |
Vivekananda Yoga Anusandhana Samsthana |
| Address |
YASA, Arogyadhama hospital, Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
08022639953 |
| Fax |
|
| Email |
dramits90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jivanti Welfare and Charitable Trust, 8/3 Asaf Ali road, New Delhi- 110002 |
|
|
Primary Sponsor
|
| Name |
Jivanti Welfare and Charitable Trust |
| Address |
8/3, Asaf Ali Road, Newdelhi,
110002 |
| Type of Sponsor |
Other [Trust] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mithila M V |
Arogyadhama |
VYASA, Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru- 560105
Bangalore Rural
KARNATAKA |
8884597683
mithila.mv@svyasa.edu.in |
| Dr Mamta Mishra |
Dirghayuh Treatment Centre |
Dirghayuh Treatment Centre
Pranitha Building
Shop 15 Sai Chowk
Khadakpada
Kalyan West Thane
Maharashtra 421301
Thane
MAHARASHTRA |
8879229490
mamtamishrapurohit@gmail.com |
| Dr Vetrivendan |
Vasista clinic |
Vasista clinic
Triveni gardens
Gorimedu
Salem
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, S-VYASA |
Approved |
| Institutional ethics Committee, S-VYASA |
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, 2 at night), for a period of 6 months |
| Comparator Agent |
Placebo |
Placebo capsules, 4 tablets per day (2 in the morning, 2 at night), for a period of 6 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Known / diagnosed Type-2 diabetics picked up from screened population with >60 score on IDRS
2. without hypertension and obesity
3. Those on oral hypo glycemic drugs [any OHA]
4. Subjects with HbA1C ≥ 6.4% |
|
| ExclusionCriteria |
| Details |
1. Morbid Obesity [BMI ≥ 40 kg/m2]
2. Subjects with 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) or severe range of obesity [BMI ≥ 40 kg/m2]
3. History of a major/ minor surgery in the past 3 months.
4. History of tuberculosis within past 3 years.
5. History of head injury, neurological or psychiatric disorder in the past
6. Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
HbA1c
Fasting Blood Sugar |
Baseline
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lipid Profile (LDL, HDL, VLDL, TC, TG)
Liver Function (SGOT, SGPT)
Kidney function(Urea, Creatinine, Uric Acid
|
Baseline
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="226" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/04/2019 |
| Date of Study Completion (India) |
22/08/2021 |
| 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
|
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.
S-VYASA (a deemed University under section 3 of UGC act 1956), is a NAAC
A+ accredited University established in 2002 with a vision to make Yoga a
socially relevant science. As a part of our mission, we have scientifically
validated Yoga practices and have been able to scientifically develop and
administer personalised disease specific Yoga modules. In 2016, our initiative ’Stop Diabetes Movement’ was adopted by
the Ministry Of AYUSH as a national program – Niyantritha Madhumeha Bharatha [NMB] – an initiative to treat and
prevent incidence of Diabetes mellitus.
Under the national scheme NMB, we have screened 2,40,968 adults for
Diabetes Mellitus across the country. Under the same scheme diagnosed diabetic
and high-risk individuals were treated with Yoga and were followed up for 3
months to understand the efficacy of Yoga, to treat diabetes and to prevent
conversion of pre-diabetics to diabetics.
In continuation, we here propose to study efficacy and mechanism of
action of Ayurveda and Yoga in prevention & management of Diabetes through
Ayurveda. Standardized ayurvedic formulation, Ayush-82 extract tablet will be
used as intervention. The study is funded under the CSR program of Jivanti Welfare and
Charitable Trust |