| CTRI Number |
CTRI/2019/12/022544 [Registered on: 30/12/2019] Trial Registered Prospectively |
| Last Modified On: |
23/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A 3 month study to observe use of advanced technology to monitor patient progress |
|
Scientific Title of Study
|
A 3 Month Observational Study To Understand The Benefit Of Twins Technology As a Supportive Tool To Enhance Medical Management Of Type II Diabetes Patients Under Ayurvedic Treatment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjhana |
| Designation |
Trial Coordinator |
| Affiliation |
Twins Digital Services India Pvt Ltd |
| Address |
D-Block, 3rd floor, Phase II, IITM Madras Research park, Kanagam road, Taramani, Chennai - 600113
Chennai
TAMIL NADU
600113
India |
| Phone |
9840556883 |
| Fax |
|
| Email |
anjhana@twinsdigital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjhana |
| Designation |
Trial Coordinator |
| Affiliation |
Twins Digital Services India Pvt Ltd |
| Address |
D-Block, 3rd floor, Phase II, IITM Madras Research park, Kanagam road, Taramani, Chennai - 600113
TAMIL NADU
600113
India |
| Phone |
9840556883 |
| Fax |
|
| Email |
anjhana@twinsdigital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjhana |
| Designation |
Trial Coordinator |
| Affiliation |
Twins Digital Services India Pvt Ltd |
| Address |
D-Block, 3rd floor, Phase II, IITM Madras Research park, Kanagam road, Taramani, Chennai - 600113
TAMIL NADU
600113
India |
| Phone |
9840556883 |
| Fax |
|
| Email |
anjhana@twinsdigital.com |
|
|
Source of Monetary or Material Support
|
| Twins Digital Services India Private limited |
|
|
Primary Sponsor
|
| Name |
Twins Digtial Services India Pvt Ltd |
| Address |
D-Block, 3rd floor, Phase II, IITM Research Park, Kanagam road, Taramani, Chennai - 600113 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Ajith Kumar |
Sadayush Ayurvedic Hospital |
Ayurveda Department, Chief physician room, #27-31, Medimix Avenue, Kalaivanar colony, Padi Pudhu Nagar, Chennai - 600 101
Chennai
TAMIL NADU |
9691964915
drajith@cholayil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RIPON |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Any patient under Ayurvedic treatment for type 2 diabetes |
|
| ExclusionCriteria |
| Details |
Type 1 Diabetes, LADA, MODI
FCPD [ Fibrocalculous pancreatic diabetes]
MODY [Maturity Onset Diabetes Of Young]
GDM [Gestational Diabetes Mellitus], Currently pregnant or breastfeeding Known HIV infection
Malignancy, SLE
Major psychiatric disorder (e.g., schizophrenia, bipolar disorder)
Major surgical procedure or significant traumatic injury within 28 days prior to Enrollment Date or anticipation of the need for major surgery during the course of study treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced one day average of glucose level as per CGM |
Reduced one day average of glucose level as per CGM |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Average of 5 days glucose value under 140 |
five days |
|
|
Target Sample Size
|
Total Sample Size="5"
Sample Size from India="5"
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)
|
30/12/2019 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Five Type 2 diabetic patients who are under Ayurvedic treatment will be enrolled including both males and females who qualify the inclusion criteria. No intervention will be provided and subjects will undergo their usual Ayurvedic treatment. Every participant will be provided the following: -
Bio sensors including wireless smart scale -
Wireless blood pressure meter -
Wireless ketone meter -
CGM patches and sensor watch -
Regular lab tests The data obtained will be analysed in the twins platform to monitor the progress of the patient under Ayurvedic treatment for 3 months. |