| CTRI Number |
CTRI/2026/01/102213 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Skin quality assessment in diabetes mellitus |
|
Scientific Title of Study
|
An observational study to assess the twak sarata in patients of 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 |
Anuja Navale |
| Designation |
PG scholar |
| Affiliation |
All India Institute of Ayurveda, Goa |
| Address |
All India Institute of Ayurveda, Dhargal, Goa.
North Goa
GOA
403512
India |
| Phone |
8421143344 |
| Fax |
|
| Email |
anujanavale2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Joshi |
| Designation |
HOD of Ayurveda Samhita Siddhanta and Sanskrit |
| Affiliation |
All India Institute of Ayurveda, Goa |
| Address |
All India Institute of Ayurveda, Dhargal, Goa.
North Goa
GOA
403512
India |
| Phone |
9822435536 |
| Fax |
|
| Email |
manvantar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Resmi B G |
| Designation |
Assistant Professor, Kriya Sharir |
| Affiliation |
All India Institute of Ayurveda, Goa |
| Address |
All India Institute of Ayurveda, Dhargal, Goa.
North Goa
GOA
403512
India |
| Phone |
9895361423 |
| Fax |
|
| Email |
resmibg.aiia@aiia.gov.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda Dhargal Goa |
| Address |
All India Institute of Ayurveda, Dhargal, Goa 403512, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuja Navale |
All India Institute of Ayurveda Dhargal Goa 403512 |
Block No 1, OPD No. 7, 10 under Kayachikitsa Department
North Goa
GOA |
08421143344
anujanavale2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients aged 30 to 50 years irrespective of gender
2 Patients diagnosed with Type 2 DM
3 Patients with HbA1c more than 6.5
|
|
| ExclusionCriteria |
| Details |
1. Patients on immunosuppressive therapy.
2. Patients with gestational diabetes.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The gradation of twak sarata according to the duration of diabetes mellitus |
The HbA1c levels and twak sarata of the patients will be assessed at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
27/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
ยท The primary objective of the study is to assess the Twak Sarata in patients with diabetes mellitus and secondary objective is to assess the association between the gradation of Twak Sarata and glycemic control duration of Diabetes Mellitus |