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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  
Name  Address 
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate),  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.
                       à®¨à®¾à®Ÿà®¿à®ªà¯à®ªà®°à®¿à®šà®®à¯ நாநிறம் மொழிவிழி

             à®®à®²à®®à¯ மூத்திரமிவை மருத்துவராயுதம்”. 

                                                                              -தேரையர்                 
  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.
 
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