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CTRI Number  CTRI/2024/10/074968 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study to assess Siddha Saliva examinations among patients with fever and thrombocytopenia in selected hospitals 
Scientific Title of Study   A cross-sectional study to assess Theraiyar vaai neer paritchai (Saliva examinations) among patients with Fever and Thrombocytopenia (Pitha suram) in selected hospitals 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varshini K 
Designation  PG scholar 
Affiliation  National Institute of Siddha 
Address  Room No 20/21 Department of Noi Nadal Ayothidoss Pandithar hospital National Institute of Siddha Tambaram Sanatorium Chennai-47

Kancheepuram
TAMIL NADU
600047
India 
Phone  8248896427  
Fax    
Email  varshini98kumar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Elansekaran S 
Designation  Associate professor 
Affiliation  National Institute of Siddha 
Address  Room No 20/21 Department of Noi Nadal Ayothidoss Pandithar hospital National Institute of Siddha Tambaram Sanatorium Chennai-47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9962536907  
Fax    
Email  sekarnis78@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Elansekaran S 
Designation  Associate professor 
Affiliation  National Institute of Siddha 
Address  Room No 20/21 Department of Noi Nadal Ayothidoss Pandithar hospital National Institute of Siddha Tambaram Sanatorium Chennai-47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9962536907  
Fax    
Email  sekarnis78@gmail.com  
 
Source of Monetary or Material Support  
Ayothidoss Pandithar hospital National Institute of Siddha Tambaram Sanatorium Chennai-47 Tamil Nadu India  
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Ayothidoss Pandithar hospital National Institute of Siddha Tambaram Sanatorium Chennai-47 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Varshini K  Ayothidoss Pandithar hospital  Room No 20/21 Department of Noi Nadal Ayothidoss Pandithar hospital National Institute of Siddha Tambaram Sanatorium Chennai-47
Kancheepuram
TAMIL NADU 
82448896427

varshini98kumar@gmail.com 
Dr Varshini K  Government Kilpauk Medical College and Hospitals  Inpatient ward number 1-8 Department of General Medicine 822 Poonomallee High Road Kilpauk Chennai-10
Chennai
TAMIL NADU 
82448896427

varshini98kumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
National Institute of Siddha  Approved 
The Institutional Ethical Committee, Government Kilpauk Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D696||Thrombocytopenia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients presenting with the complaints of fever (greater than 99.9 F) and thrombocytopenia (less than 1,50,000/µL) 
 
ExclusionCriteria 
Details  Patient with serious illness.
Pregnancy/Lactation.
Patients who are not willing to participate in the study and sign in the consent
Patients having afebrile thrombocytopenia.
Congenital thrombocytopenia.
Patients who undergone any kind of dental work one day prior to collection of samples.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association between salivary findings and fever with thrombocytopenia will be determined.  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Specific Viscosity of the saliva in fever with thrombocytopenia will be documented  18 months 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   21/10/2024 
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 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  

Sage Theraiyar has explained eight types of diagnostic methods in his text, which is called -Envagai Thervul (Eight folded examination). It consists of the examination of Naadi (Pulse), Sparisam (Touch), Naa (Tongue), Niram (Colour), Mozhi (Voice), Vizhi (Eyes), Malam (Feces), and          Neer (Urine). Manikadainool (Measuring Wrist circumference), Maruthuva Jothidam, Pancha patchi has also fall under Siddha diagnostic methodology.In Envagai thervugal Naa Paritchai is one among them included with Vaai Neer Paritchai by sage Theraiyar. 

Saliva as a fluid for diagnostic purposes would be a huge breakthrough for both patients and healthcare providers since saliva collection is easy, non-invasive and inexpensive. Pitha suram  falls under Than Vazhi Suram. As per T.V SAMBASIVAM PILLAI dictionary, PITHA SURAM  [2] is denoted as a virulent fever cause by excitement of bile humour. So, Fever with thrombocytopenia is considered as  PITHA SURAMBy reviewing the fever with thrombocytopenia like Google Scholar, etc., Siddha diagnostic tools like an observation of Siddha diagnostic parameter, Saliva examination in fever with thrombocytopenia [5] and there are no research articles published in indexed journals regarding a study on the diagnostic methodology in fever with thrombocytopenia in Siddha as much. So, with the aim to establish the diagnostic methods (vaai neer paritchai) for the above disease based on the Siddha concept in mind, selected the disease fever with thrombocytopenia and aims to shed light on the unforeseen prospects of improving the diagnostic methods in the detection of fever with thrombocytopenia.

OBJECTIVE:

         To assess the Salivary examination in Theraiyar Vaai Neer Paritchai mentioned in Siddha literature for fever with thrombocytopenia (Pitha Suram)

METHODOLOGY:

This is a cross sectional observational study among the fever with thrombocytopenia patients which will be carried out 18 months period with the sample size of 82 patients in Tamilnadu.

·   Participants will be asked to collect approximately 15 mL of saliva by passive drooling method over a span of 10 minutes, into a plastic vial. The goal for saliva collection included diminishing the amount of air bubbles trapped within the saliva, by collecting the saliva very carefully, slowly, and with as little movement as possible. Foam-like saliva that is saturated with small air bubbles were not included in the overall 15 mL amount of passive saliva collected.

·    Salivary pH was measured using a calibrated pH meter and salivary viscosity were determined by viscometer as per standard protocol.

·    Patient’s symptoms, Envagai thervu findings, and manikadai nool will be documented in the CRF. The result will be described through descriptive statistics.

OUTCOME OF STUDY:

·       Association between Salivary findings and fever with thrombocytopenia will be determined.

·       Specific Viscosity of the saliva in fever with thrombocytopenia will be documented.

 
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