| CTRI Number |
CTRI/2017/11/010590 [Registered on: 22/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Study on early detection of dengue disease |
|
Scientific Title of Study
|
Mobile Dengue Diagnostic Technology (m-DDT):
A smartphone-based point-of-care diagnostics and early warning system for epidemic prediction, preparedness and control.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sai Sathish Ramamurthy |
| Designation |
Principal Investigator |
| Affiliation |
Sri Sathya Sai Institute of Higher Learning |
| Address |
Department of Chemistry
SSSIHL Prasanthi Nilayam campus, Puttaparthi
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
8790314405 |
| Fax |
|
| Email |
rsaisathish@sssihl.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sai Sathish Ramamurthy |
| Designation |
Principal Investigator |
| Affiliation |
Sri Sathya Sai Institute of Higher Learning |
| Address |
Department of Chemistry
SSSIHL Prasanthi Nilayam campus, Puttaparthi
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
8790314405 |
| Fax |
|
| Email |
rsaisathish@sssihl.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sai Sathish Ramamurthy |
| Designation |
Principal Investigator |
| Affiliation |
Sri Sathya Sai Institute of Higher Learning |
| Address |
Department of Chemistry
SSSIHL Prasanthi Nilayam campus, Puttaparthi
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
8790314405 |
| Fax |
|
| Email |
rsaisathish@sssihl.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Sathya Sai Institute of Higher Learning (Deemed to be University) |
|
|
Primary Sponsor
|
| Name |
Sri Sathya Sai Institute of Higher Learning |
| Address |
Vidyagiri, Prasanthi Nilayam, Puttaparthy - 515134, Anantapur District, Andhra Pradesh |
| Type of Sponsor |
Other [Private Academic Institution (Deemed to be University)] |
|
|
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 Muddu Gopi Krishna |
Sri Sathya Sai General Hospital |
Room No. 27, OPD Section, Department of Pediatrics, Prasanthi Nilayam, Puttaparthi 515134
Anantapur
ANDHRA PRADESH |
9676708496
gopikrishna.dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Sathya Sai Institute of Higher Learning |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A90||Dengue fever [classical dengue], |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age: 6 years to 80 years
Disease State: The patient is diagnosed with Dengue if he/she comes in with fever combined with 2 of the following additional symptoms:
Headache, Retro-orbital pain, Myalgia, arthralgia, Rash, hemorrhagic manifestations, Petechiae, Purpurae, Platelets <1,00,000, Joint Pains, Hematocrit count >20% from Baseline.
|
|
| ExclusionCriteria |
| Details |
Patients with previous (past 3 months) blood transfusion and/or platelet transfusion are excluded from the study.
Patients below the age of 6 years and pregnant woman are excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hand-held device for diagnosis, prognosis and differentiation of vector-borne disease, dengue.
We intend to extend the device’s capability as a multi-analyte sensing platform to evaluate the presence of alternate vector-borne diseases.
|
First sample is collected at Febrile stage. Second sample is collected at Critical phase. Third sample is collected at recovery phase. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We intend to extend the device’s capability as a multi-analyte sensing platform to evaluate the presence of alternate vector-borne diseases. |
4 years |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
18/07/2017 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
In this work, we intend to develop a portable, hand-held
medical diagnostic device that will be capable of diagnosis and prognosis of
the vector-borne disease dengue with genotypic specificity. On realizing the
initial prototype we intend to extend the device’s capability as a
multi-analyte sensing platform to evaluate the presence of alternate
vector-borne diseases such as: Malaria, Zika and Chikungunya. The novelty of
this device is the determination of major vector-borne disease infection status
in real time without the need for any high-end equipment or laboratory
procedures. |