| CTRI Number |
CTRI/2024/07/071309 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Proteomic investigation on healthy, diabetic and diabetic neuropathy subjects with respect to ayurveda constitution |
|
Scientific Title of Study
|
Proteomics investigation on the serum samples from diabetic neuropathy patients with vata, pitta and kapha prakriti constitution |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niranjana GopalK |
| Designation |
Post Doctoral Fellow |
| Affiliation |
Inter University Centre for Biomedical Research and Super Speciality Hospital |
| Address |
Nikunjasree
Kulakode
Vellanad
Center for developmental and ageing research
IUCBR and SSH
Mahatma Gandhi University Campus at Thalapaddy
Rubber board PO
Kottayam
Kerala 686009
Kottayam
KERALA
695543
India |
| Phone |
8113057109 |
| Fax |
|
| Email |
niranjanagopalk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K P Mohanakumar |
| Designation |
Director |
| Affiliation |
Inter University Centre for Biomedical Research and Super Speciality Hospital |
| Address |
Inter University Centre for Biomedical Research and Super Speciality Hospital
Mahatma Gandhi University Campus at Thalapaddy
Rubber board PO
Center for developmental and ageing research
Mahatma Gandhi University Campus at Thalapaddy
Rubber board PO
Kottayam
Kerala 686009
Kottayam
KERALA
686009
India |
| Phone |
7356763041 |
| Fax |
|
| Email |
iucbr@mgu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niranjana GopalK |
| Designation |
Post Doctoral Fellow |
| Affiliation |
Inter University Centre for Biomedical Research and Super Speciality Hospital |
| Address |
Nikunjasree
Kulakode
Vellanad
Center for developmental and ageing research
Mahatma Gandhi University Campus at Thalapaddy
Rubber board PO
Kottayam
Kerala 686009
Kottayam
KERALA
695543
India |
| Phone |
8113057109 |
| Fax |
|
| Email |
niranjanagopalk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences(CCRAS)
Ministry of AYUSH, Govt. of India agency |
| Inter University Centre for Biomedical Research & Super Speciality Hospital (IUCBR&SSH)
Mahatma Gandhi University Campus at Thalapaddy, Rubber board PO
Kottayam, Kerala 686009
|
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences(CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences(CCRAS) Ministry of AYUSH
Govt. of India
Room No.206
2nd Floor
JLNBCHA Bhawan 61-65 Institutional Area
Opp. D Block
Janakpuri
New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
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 |
| DrNiranajana |
Inter University Centre for Biomedical Research & Super Speciality Hospital |
Mahatma Gandhi University Campus at Thalapaddy, Rubber Board PO
Kottayam
Kerala 686009
Kottayam
KERALA |
8113057109
niranjanagopalk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy individuals with HbA1c less than 6.5 and with out any other comorbidity |
| Patients |
(1) ICD-10 Condition:E114||Type 2 diabetes mellitus with neurological complications. Ayurveda Condition: PRAKRUTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
a) Diabetic persons aged between 30-45 years having Hba1c within 6.5% or higher.
b) Diabetic subjects with DPN
c) Individuals undergone 8 h fasting will be included in the study.
d) Diabetic subjects taking only metformin medicine
e) Blood samples from females will be collected on the 14 th -18 th day after the first day
of last menstrual cycle. |
|
| ExclusionCriteria |
| Details |
a) Individuals with any comorbidities
b) Individuals should not be on any other medication, for any ailments.
c) Females under menstruation, lactating and pregnant
d) Unwilling participants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| a) A detailed understanding of the serum proteome in blood samples of individual with 3 different prakriti |
a) A detailed understanding of the serum proteome in blood samples of individual with 3 different prakriti
will be completed in first year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
b) A comprehensive understating of changes in proteome, if any in diabetic subjects with identified constitutions.
c) An inclusive understating of DPN related protein marker in sera samples for the subjects with vata, pitta and kapha constitutions.
d) Ultimately the study will provide a knowledgebase on proteome of blood sera samples in relation to different prakriti, diabetics and diabetic neuropathy.
|
b) A comprehensive understating of changes in proteome, if any in diabetic subjects with identified constitutions.
c) An inclusive understating of DPN related protein marker in sera samples for the subjects with vata, pitta and kapha constitutions.
d) Ultimately the study will provide a knowledgebase on proteome of blood sera samples in relation to different prakriti, diabetics and diabetic neuropathy.
will be completed with in two years |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
04/08/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Investigating the proteomics in Type 2 Diabetics mellitus and Diabetic Neuropathy(DPN) with in the individual having different Ayurveda prakriti, will help to understand the specific range of different protein and in turn pave the way to development of design for the individual diagnostic tool, prognosis tool, and treatment modality for DPN and diabetic patient. We expand upon those results with integrated, proteomics, to compare the molecular profiles of DPN donors with 3 different prakriti from control donors without diabetes or chronic pain. These results will provide a new insight into changes in the molecular profiles associated with DPN
i. To generate a comprehensive understanding of the relationship between body types and the risk of developing Diabetics mellitus and Diabetic Neuropathy by selecting control individuals, as well as subjects with DM and DPN based on vata, pitta and kapha individuals ii. To evaluate the proteome in blood sera samples of control individuals with three distinct Prakriti constitutions. Specifically, we seek to evaluate the differential protein expression among normal subjects having these different prakriti constitutions. iii. To examine the alterations in proteome levels in individuals with DM and DPN who possess varying prakriti constitutions. iv. To identify novel biomarkers that can accurately predict the onset and progression of DPN in patients with different constitutions by discovering potential protein markers associated |