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CTRI Number  CTRI/2025/05/086505 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 07/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   Study on Ushna vaayu meni chooranam in the management of Azhal thalai nokkadu( Mokkadaipu) 
Scientific Title of Study   Single centric non randomized open clinical trial phase II in Azhal thalai nokkadu with siddha medicine Ushna vaayu meni chooranam among patients attending OPD at government siddha medical College Chennai  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saranya R 
Designation  PG Scholar  
Affiliation  Government Siddha Medical College,chennai  
Address  Department of PG pothu maruthuvam, government siddha medical College Chennai

Chennai
TAMIL NADU
600103
India 
Phone  9597437499  
Fax    
Email  saranyarajamanierode@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr U Chithra  
Designation  Lecturer, Department of PG pothu maruthuvam  
Affiliation  Government siddha medical College Chennai  
Address  Department of PG pothu maruthuvam, government siddha medical College Hospital Chennai

Chennai
TAMIL NADU
600106
India 
Phone  9445716802  
Fax    
Email  mmsankar2000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr U Chithra  
Designation  Lecturer, Department of PG pothu maruthuvam  
Affiliation  Government siddha medical College Chennai  
Address  Department of PG pothu maruthuvam, government siddha medical College Hospital Chennai


TAMIL NADU
600106
India 
Phone  9445716802  
Fax    
Email  mmsankar2000@gmail.com  
 
Source of Monetary or Material Support  
Government Siddha Medical College,Arumbakkam,Chennai600106 
 
Primary Sponsor  
Name  Government Siddha Medical College Chennai  
Address  No-6, anna arch road, Arumbakkam,Chennai600106 
Type of Sponsor  Government medical college 
 
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 Saranya R   Government Siddha Medical College Hospital, Chennai  Department of PG pothu Maruthuvam,Room No S1, Government Siddha Medical College Hospital,Chennai
Chennai
TAMIL NADU 		 9597437499

saranyarajamanierode@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Arumbakkam, Chennai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J019||Acute sinusitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Ushna Vaayu Meni Chooranam   Drug given by 45 days Dosage - 1 varaganadai Adjuvant - Honey or ghee 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Nasal congestion
Headache
Rhinorrhea
Pain and tenderness over the paranasal sinus  
 
ExclusionCriteria 
Details  Septal deviation
Ophthalmic headache
Trigeminal neuralgia
Nasal polyposis
Pregnancy& Lactation  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To reduction the clinical symptoms   45 days  
 
Secondary Outcome  
Outcome  TimePoints 
Adelaide disease severity score   45 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 2 
Date of First Enrollment (India)   23/05/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [saranyarajamanierode@gmail.com].

  6. For how long will this data be available start date provided 09-05-2025 and end date provided 09-05-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Sinusitis is an inflammation or swelling of the tissue lining of sinuses.sinusitis are four paired cavities inside the head.sinuses make mucus that drains out of the passage through nose.It can cause pressure and pain in the face,nasal congestion, and other symptoms.In siddha system of medicine,there are unique combination  of medicines,one such combination is Ushna vaayu meni chooranam,which will be more effective and reliable. 
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