| 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
|
|
|
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
|
|
|
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 SURAM. By 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. |