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CTRI Number  CTRI/2024/06/069317 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 13/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of nasya in sinusitis. 
Scientific Title of Study   A Randomized comparative clinical trial to evaluate the efficacy of bharangyadi taila nasya and shadabindu taila nasya with Chitrak haritaki avaleha in kaphaja shiroroga with special reference to chronic maxillary sinusitis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shital Chaudhari 
Designation  Pg scholar 
Affiliation  National Institute of Ayurveda, Jaipur. 
Address  702-A wing,Urbano Society,Kesanand Road,wagholi pune 412207.
National Institute of Ayurveda, jaipur 302002
Pune
MAHARASHTRA
412207
India 
Phone  7600305008  
Fax    
Email  shitalchaudhari6071@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aparna sharma 
Designation  PhD,Shalakya, Ayurveda 
Affiliation  National Institute of Ayurveda 
Address  Shalakya tantra department, 3rd floor Academic building, national institute of ayurveda, jaipur,Rajasthan,302002.

Jaipur
RAJASTHAN
302002
India 
Phone  8955688129  
Fax    
Email  appu07@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr shital chaudhari 
Designation  Pg scholarShalakya, Ayurveda 
Affiliation  National Institute of Ayurveda 
Address  702-A wing Urbano Society, Kesanand Road, Wagholi pune 412207

Pune
MAHARASHTRA
412207
India 
Phone  7600305008  
Fax    
Email  Shitalchaudhari6071@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, jaipur, rajasthan, India 302002 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
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 Aparna sharma  National Institute of Ayurveda, jaipur   Opd no 13, National Institute of Ayurveda, jaipur 302002
Jaipur
RAJASTHAN 		 7600305008

shitalchaudhari6071@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee national institute of Ayurveda Jaipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J320||Chronic maxillary sinusitis. Ayurveda Condition: KAPAJA-SIROROGAH/KAPAJA SIROBITAPA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-nasyam, नस्यम् (Procedure Reference: Susruta samhita, Procedure details: First of all snehana swedana done on face and neck area then medicated oil or ghrita insert in nose by droper in both nonstrils and then gargles )
(1) Medicine Name: Bharangyadi taila, Reference: Charaka samhita, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 0.3(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Heaviness in head along with dull pain and numbness (guru gauravyukta)
2. Feeling of the head being covered with wet cloth (kaphalipta).
3. Sticky mucus secretion in throat (kaphopadigdhamiti)
4. Swelling of face and eye sockets occurs (sunakshikuta).
5. Headache is less severe than acute sinusitis.
6. Nasal obstruction.
7. Nasal and Post nasal purulent discharge.
8. Facial pain and pressure.
9. Disturbance of smell (hyposmia or anosmia).
10. Patient with chronic maxillary sinusitis were included.
11. Age from 16 years to 70 years. 
 
ExclusionCriteria 
Details  1. Patient not willing for the trial were excluded.
2. Patient with acute maxillary sinusitis were excluded.
3. Pregnant women.
4. Lactating women.
5. Patient suffering from Gastritis with sensitive stomach.
6. Patient suffering from diabetes
7. Patient aged below 16 years and above 70 years.
8. Patients suffering from headache of all other causes except Chronic maxillary sinusitis.
9. Patient suffering from cellulitis of cheek and nasal furuncle.
10. Patient with malignancy of sinuses. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Symptomatic relief
Prevention of recurrence 		 30 days trial 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in complications
Reduced quality of life
Nasal polyp
Psychological impacts
Etc 		 Decreased opacification in x ray  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/07/2024 
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="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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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
    Response - None of the above
    Response (Others) - 
  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included Yes).

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   A randomized clinical trial to evaluate the efficacy of bharangyadi taila nasya and shadbindu taila nasya with Chitrakoot haritaki avaleha in kaphaja Shiro roga w.s.r. to chronic maxillary sinusitis  
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