| CTRI Number |
CTRI/2025/03/082853 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of dietary pattern with advanced glycation end products (AGEs) and high senstivity C reactive protein (hs-CRP) in patients of MADHUMEHA w. s. r to Type II Diabetes Mellitus. |
|
Scientific Title of Study
|
Association of dietary pattern with advanced glycation end products and high senstivity C reactive protein in patients of MADHUMEHA w. s. r to Type II Diabetes Mellitus. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr kajal Singh |
| Designation |
MD scholar |
| Affiliation |
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India |
| Address |
6th Floor Room no. 622(Seminar Hall) Department Of Swasthavritta
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi
South DELHI 110076 India
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
6263010141 |
| Fax |
|
| Email |
Singhkajal8878@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivakumar S Harti |
| Designation |
Additional professor |
| Affiliation |
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India |
| Address |
6th Floor Room no. 602 Department Of Swasthavritta
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi
South DELHI 110076 India
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
9611275434 |
| Fax |
|
| Email |
shivkumar.harti@aiia.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivakumar S Harti |
| Designation |
Additional professor |
| Affiliation |
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India |
| Address |
6th Floor Room no. 602 Department Of Swasthavritta
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi
South DELHI 110076 India
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
9611275434 |
| Fax |
|
| Email |
shivkumar.harti@aiia.gov.in |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
Gautampuri Sarita Vihar New Delhi 110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 kajal Singh |
All India Institute Of Ayurveda |
6th Floor Room no.622(Seminar Hall) Department Of Swasthavritta All India Institute Of
Ayurveda Gautampuri
Sarita Vihar New Delhi
110076 South DELHI
South DELHI
South
DELHI
South
DELHI |
6263010141
singhkajal8878@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIA Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Type II DM for 1 year controlled and uncontrolled.
Age range of 21 years and above.
HbA1c range -6.5% to 9.5%. |
|
| ExclusionCriteria |
| Details |
Severe hypoglycemic episode (requiring assistance) during the last 3 months.
Pregnant women.
Patients with- severe diabetes complications.
Hyperglycemia-induced ketoacidosis in the last month other autoimmune diseases such as celiac disease.
Reported energy intake out of 800-4200 kcal were exclude.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The association between dietary patterns and levels of Advanced glycation end products and high-sensitivity C-reactive protein with madhumeha (Diabetes Mellitus) relative to Type II DM.
|
At baseline, 4 week, 8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Overall improvement in the quality of life
|
At baseline, 4 week, 8 week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/04/2025 |
| 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)
|
Not Applicable |
| 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
|
Dietary intakes is going to assess using a validated food frequency questionnaire (FFQ). This questionnaire is design specifically for North Indian food. With the help of an interview, FFQ for each participant will be filled. Finally, based on the consumption frequency of each item and serving size, we will be calculating the gr/day intake for each food item. In addition, we will calculate the daily nutrient intake for each participant according to the nutrient content of all foods Diet pattern will be constructed into 4 category- Western dietary pattern unhealthy dietary pattern Traditional dietary pattern Semi healthy dietary pattern
|