| CTRI Number |
CTRI/2025/12/098802 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
06/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ASSOCIATION OF DHATUPAKA IN DIAGNOSED PATIENTS OF CHRONIC KIDNEY DISEASE - A DESCRIPTIVE STUDY |
|
Scientific Title of Study
|
A DESCRIPTIVE STUDY OF ASSOCIATION OF DHATUPAKA IN DIAGNOSED PATIENTS OF CHRONIC KIDNEY DISEASE. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akanksha Prashant Lajurkar |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune |
| Address |
Rognidan Department,Tilak Ayurved Mahavidyalaya, Rasta peth, Pune, Maharashtra- 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9588680267 |
| Fax |
|
| Email |
lajurkara99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjiri Deshpande |
| Designation |
Professor MD PhD Rognidan |
| Affiliation |
Tilak Ayurved Mahavidyalaya Rastapeth Pune |
| Address |
Rognidan Department,Tilak Ayurved Mahavidyalaya, Rasta peth, Pune, Maharashtra- 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9960081113 |
| Fax |
|
| Email |
drmanjirideshpande24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Manjiri Deshpande |
| Designation |
Professor MD PhD Rognidan |
| Affiliation |
Tilak Ayurved Mahavidyalaya Rasta peth Pune |
| Address |
Rognidan Department,Tilak Ayurved Mahavidyalaya, Rasta peth, Pune, Maharashtra- 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9960081113 |
| Fax |
|
| Email |
drmanjirideshpande24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya Rasta Peth Pune Maharashtra 411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Rasta Peth Pune Maharashtra 411011 |
| 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 Akanksha Prashant Lajurkar |
Tilak Ayurved Mahavidyalaya , Seth Tarachand Ramnath Chartiable Ayurved Hospital , Pune |
Site address - Tilak
Ayurved Mahavidyalaya, 583/2 Rasta Peth, Pune, Department of Rognidan
For clinical study - Department of Rognidan (ayurvedic diagnostics)/Kayachikitsa(ayurvedic medicine) and pathology
Pune
MAHARASHTRA |
9588680267
lajurkara99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TILAK AYURVEDA MAHAVIDYALAYA AND SETH TARACHAND RAMNATH CHARITABLE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N189||Chronic kidney disease, unspecified. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Individuals with age between 20-70 years.
2) Known case of chronic kidney disease patients from affiliated hospital.
3) Participants will be selected irrespective of gender, religion, marital status, economic status.
4) Patients diagnosed with chronic kidney disease stage 3, 4 and 5 with decreased estimated glomerular filtration rate of less than 60 ml/min/1.73 m² and increased sr. creatinine and sr. blood urea level. |
|
| ExclusionCriteria |
| Details |
1) Patients who are diagnosed with chronic kidney disease stage 1 and 2 with an estimated glomerular
filtration rate more than 60 ml/min/1.73 m².
2) Participants sr. creatinine and sr. blood urea level within normal range.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association of Dhatupaka lakshana in chronic kidney disease. |
18 Months and 0 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study stagewise correlation between Ayurvedic Dhatupaka symptoms and clinical stages of CKD. |
18 months and 0 weeks |
| To study predominant dhatu dushti in diagnosed patients of CKD. |
18 months and 0 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
23/12/2025 |
| 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="1"
Months="6"
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
|
The study aims to explore the ayurvedic pathogenesis in Chronic Kidney Disease patients from the perspective of Dhatupaka, thereby enhancing the understanding of chronic diseases within ayurvedic parameters.
To study the association of Dhatupaka lakshana in chronic kidney disease.
To study stagewise correlation between ayurvedic Dhatupaka symptoms and clinical stages of CKD.
To study predominant dhatu dushti in diagnosed patients of CKD. |