| CTRI Number |
CTRI/2026/03/105964 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the causes of Kleda ( Body fluid imbalance ) in Type 2 Diabetes Patients |
|
Scientific Title of Study
|
A CROSS SECTIONAL STUDY TO ASSESS THE ETIOLOGICAL FACTORS OF KLEDAVRUDDHI IN TYPE 2 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 Ashish Laxman Gaikwad |
| Designation |
PG scholar |
| Affiliation |
pdeas college of ayurveda and research center nigdi pune 411044 |
| Address |
1st floor rognidan evum vikriti vigyan department pdeas college of ayurveda and research centre nigdi pradhikaran pune 411044
sector 27 near vitthal rukhmini temple nigdi pradhikaran pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9404504226 |
| Fax |
|
| Email |
a9404504226@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyendrakumar Singh |
| Designation |
associate professor |
| Affiliation |
pdeas college of ayurveda and research center nigdi pune 411044 |
| Address |
1st floor rognidan evum vikriti vigyan department pdeas college of ayurveda and research centre nigdi pradhikaran pune 411044
sector 27 near vitthal rukhmini temple nigdi pradhikaran pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9890741683 |
| Fax |
|
| Email |
drsatyendra1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyendrakumar Singh |
| Designation |
associate professor |
| Affiliation |
pdeas college of ayurveda and research center nigdi pune 411044 |
| Address |
1st floor rognidan evum vikriti vigyan department pdeas college of ayurveda and research centre nigdi pradhikaran pune 411044
sector 27 near vitthal rukhmini temple nigdi pradhikaran pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9890741683 |
| Fax |
|
| Email |
drsatyendra1981@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
pdeas college of ayurveda and research center |
| Address |
1st floor rognidan evum vikriti vigyan department pdeas college of ayurveda and research centre nigdi ,pradhikaran pune 411044 maharastra |
| Type of Sponsor |
Private medical college |
|
|
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 Ashish Gaikwad |
ayurveda rugnalay and snowbell multispeciality hospital |
ARSMH sector 27 near vitthal rukhmini temple nigdi pradhikaran pune 411044
Pune
MAHARASHTRA |
9404504226
a9404504226@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAS COLLEGE INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
diagnosed cases of Type 2 Diabetes Mellitus
age group between 30 to 60 years |
|
| ExclusionCriteria |
| Details |
Patients with chronic disorders such as renal failure, cardiac failure,
Diabetic foot, Gangrene, Cancer.
Patients with Diabetic Retinopathy, Neuropathy, Nephropathy.
Patients with having Co-morbidity such as Hypertension, Thyroid,
Autoimmune disease, Systemic lupus erythematosus. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the etiological factors of Kledavruddhi in Type 2 Diabetes Mellitus |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/03/2026 |
| 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
|
Type 2 Diabetes Mellitus is rapidly increasing in prevalence across both urban and rural populations in India, posing a significant public health challenge. In Ayurvedic literature, Type 2 Diabetes Mellitus is primarily correlated with Madhumeha, a subtype of Prameha, which is characterized by Kleda-dominance in its pathophysiology (Samprapti)3-6. Kleda, although a fundamental component in the disease mechanism, is not routinely assessed or quantified in contemporary clinical practice. Despite being recognized as a key Samprapti Ghataka, the etiological factors (Hetus) contributing to Kleda-vruddhi remain underexplored, particularly in patients with Type 2 Diabetes Mellitus. Furthermore, while Ayurvedic texts offer robust theoretical insights, there exists a significant gap in clinical research linking specific Kleda-associated dietary and lifestyle practices with the pathogenesis of Type 2 Diabetes Mellitus. Therefore, the present Cross-sectional study is designed to: Systematically identify prevalent dietary and behavioral practices that act as Kleda-vardhaka Hetus, Evaluate their contribution to the etiopathogenesis of T2DM from an Ayurvedic perspective. Understanding the role of Kledavruddhi in disease causation can offer novel preventive strategies rooted in diet-lifestyle modification and Ayurvedic pathophysiology, ultimately aiding in integrative diabetes management. |