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CTRI Number  CTRI/2024/09/073492 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 03/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Diagnostic Methods Standardisation in Siddha for Blood Cancer  
Scientific Title of Study   Standardisation of Siddha Diagnostic Methods in Conditions of Leukaemia-Rattha Vippuruthi 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ULAGAMADHAVAN M 
Designation  PG SCHOLAR 
Affiliation  NATIONAL INSTITUTE OF SIDDHA 
Address  Room no 20/21, Department of Noi Naadal, Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai-47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9842706576  
Fax    
Email  ulagamadhavanm98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr G J Christian  
Designation  Head of the Department 
Affiliation  NATIONAL INSTITUTE OF SIDDHA 
Address  Room no 20/21, Department of Noi Naadal, Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai-47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr G J Christian  
Designation  Head of the Department 
Affiliation  NATIONAL INSTITUTE OF SIDDHA 
Address  Room no 20/21, Department of Noi Naadal, Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai-47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Source of Monetary or Material Support  
Room no 20/21, Department of Noi Naadal, Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, 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
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr ULAGAMADHAVAN M  Rajiv Gandhi Government General Hospital  Room no:141,144, Female and Male Inpatient ward, Department of Haematology, 4th Floor, Tower-1.
Chennai
TAMIL NADU 		 09842706576

ulagamadhavanm98@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MADRAS MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C959||Leukemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients who are diagnosed as Leukaemia with proper reports 
 
ExclusionCriteria 
Details  Myeloproliferative disoreders such as Polycythemia vera, Essential thrombocytosis, Primary myelofibrosis, Mastocytosis
Lymphomas 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diagnostic findings in conditions of leukaemia (Rattha Vippuruthi) with reference to Siddha Diagnostic parameters  Baseline 0th day 
 
Secondary Outcome  
Outcome  TimePoints 
Maruthuva Jothidaviyal (Medical Astrology) findings will be documented through descriptive statistic method.
Relationship of Panchapatchi calculation will be documented through descriptive statistic method. 		 Baseline 0th day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   20/09/2024 
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
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

BACKGROUND

This study will be helpful to standardize the various diagnostic methods of Siddha system for the various conditions of Leukaemia. Knowledge gained from this study would be of benefit for future Siddha research in the field of cancer.

OBJECTIVE

PRIMARY OBJECTIVE

            To document the diagnostic findings in conditions of leukaemia (Rattha vippuruthi) with reference to Siddha diagnostic parameters.

SECONDARY OBJECTIVE

            To document the relationship of Maruthuva Jothidam with Leukaemia in the subjects included in the research.

            To document the relationship of Panchapatchi calculation with leukaemia in the subjects.

MATERIALS AND METHODS

STUDY TYPE

 Observational study.

STUDY DESIGN

Cross sectional study.

SAMPLE SIZE

50 Patients

STUDY SITE

Rajiv Gandhi Government General Hospital,

Park Town

chennai-03.

STUDY PERIOD

18 months

STUDY TIMELINE

Topic selection - 1st month.

Collection of literature -1st to 2nd month.

Appearing for screening - 3rd to 5th month.

Preparation of protocol - 5th month.

Approval of IEC - 6th month.

CTRI Registration - 7th to 8th month.

Selection of cases - 9th to 13th month.

Data entry – 14th to 15th month.

Pre-consolidation – 15th to 16th month.

Analysis & Interpretation – 16th to 17th month.

Discussion, Revision & Submission – 18th month.

 SELECTION CRITERIA

 INCLUSION CRITERIA

GENDER: Male, Female, Transgender. Age limit - 5 years - 70 years.

Patients who are diagnosed as Leukaemia with proper reports.

 EXCLUSION CRITERIA

Myeloproliferative disorders such as Polycythemia vera, Essential thrombocytosis, Primary myelofibrosis, Mastocytosis.

Lymphomas

OUTCOME OF THE STUDY

 PRIMARY OUTCOME

Diagnostic findings in conditions of leukaemia (Rattha vippuruthi) with reference to Siddha diagnostic parameters.

SECONDARY OUTCOME

         Maruthuva Jothidaviyal findings will be documented through descriptive statistic method.

         Relationship of Panchapatchi calculation will be documented through descriptive statistic method.

 

 
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