CTRI Number |
CTRI/2023/07/055100 [Registered on: 11/07/2023] Trial Registered Prospectively |
Last Modified On: |
29/11/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
SIDDHA DIAGNOSIS FOR CHRONIC KIDNEY DISEASE |
Scientific Title of Study
|
An Observational Study on the diagnostic methodology and
symptomatology in patients with chronic kidney disease |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Pmenaga |
Designation |
PG Scholar |
Affiliation |
National Institute of Siddha |
Address |
National Institute of Siddha Tambaram Sanatorium Chennai TAMIL NADU Dr P Menaga India |
Phone |
09952436558 |
Fax |
|
Email |
menagasuresh72@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
M Ramamurthy |
Designation |
Associate Professor |
Affiliation |
National Institute of Siddha |
Address |
Department of Noi Naadal National Institute of Siddha
Tambaram Sanatorium
Chennai Department of Noi Naadal National Institute of Siddha
Tambaram Sanatorium
Chennai Chennai TAMIL NADU 600047 India |
Phone |
09952436558 |
Fax |
|
Email |
ramsnis@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Pmenaga |
Designation |
PG Scholar |
Affiliation |
National Institute of Siddha |
Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai National Institute of Siddha
Tambaram Sanatorium
Chennai Chennai TAMIL NADU Dr P Menaga India |
Phone |
09952436558 |
Fax |
|
Email |
menagasuresh72@gmail.com |
|
Source of Monetary or Material Support
|
Ayothidoss Pandithar Hospital
National Institute of Siddha
Chennai-47. |
|
Primary Sponsor
|
Name |
Nil |
Address |
Nil |
Type of Sponsor |
Other [Nil] |
|
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 P Menaga |
OP ROOM NO 20/21 DEPARTMENT OF NOI NAADAL National Institute of Siddha |
OP ROOM NO 20/21 DEPARTMENT OF NOI NAADALNational Institute of Siddha
Tambaram Sanatorium
Chennai Chennai TAMIL NADU |
09952436558
menagasuresh72@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: N183||Chronic kidney disease, stage 3 (moderate), |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
13.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
GFR < 60 ml/min more than ≥3 months (G3-G5 stages of chronic kidney disease
patients and Patients with dialysis
CKD patients who are willing to participate in the study will be enrolled through informed
consent |
|
ExclusionCriteria |
Details |
Pregnancy/Lactation
CKD patients who are not willing to participate in the study and sign in the
consent |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Elucidating the clinical findings laboratory findings Envagai thervu findings
and Manikadai nool findings in the condition of chronic kidney disease. |
18 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Nil |
Nil |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
12/07/2023 |
Date of Study Completion (India) |
11/09/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
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
|
PROTOCOL SUMMARY An Observational Study On The Diagnostic Methodology And Symptomatology In Patients With Chronic Kidney Disease
INTRODUCTION: Chronic kidney disease (CKD) is defined by the Kidney Disease Outcomes Quality Initiative (KDOQI) as manifested by either pathologic abnormalities or markers of kidney damage GFR<60 ml/minute/1.73m² for ≥3 months, with or without kidney damage is divided into five stages based on GFR. As per T.V SAMBASIVAM PILLAI dictionary, PIRUKKAM is denoted as KIDNEY. So, chronic kidney disease is considered PIRUKKA NOI. நாடிபà¯à®ªà®°à®¿à®šà®®à¯ நாநிறம௠மொழிவிழி மலம௠மூதà¯à®¤à®¿à®°à®®à®¿à®µà¯ˆ மரà¯à®¤à¯à®¤à¯à®µà®°à®¾à®¯à¯à®¤à®®à¯â€. -தேரையர௠Eight types of diagnostic methods in his text, which is called -Envagai Thervul (Eight folded examination).Manikadainool (Measuring Wrist circumference) will be used in this study. CKD is usually asymptomatic in its early stages (1-3). Symptoms and metabolic complications (e.g., anemia, hyperparathyroidism, water, and electrolyte imbalance) usually appear at later stages when GFR drops below 30 mL/minute/1.73 m².
OBJECTIVE: To conduct a descriptive study on chronic kidney disease with reference to Siddha diagnostic parameters.
STUDY DESIGN: An Observational study using a purposive sampling technique will be carried out for 18 months in the OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, with 30 patients as the sample size. The patients will be selected as per inclusion and exclusion criteria. After getting consent, the patients will be enrolled in the study. Documentation of symptoms will be done, Envagai thervu and manikadai nool will be observed and documented. The result will be described through descriptive statical.
OUTCOME: Elucidating the clinical findings, laboratory findings, Envagai thervu findings and Manikadai nool findings in the condition of chronic kidney disease. |