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CTRI Number  CTRI/2024/11/077311 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 23/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Ayurveda nasal drop on chronic sinusitis in children 
Scientific Title of Study   To evaluate the efficacy of Dharvyadi Arka nasal drop in the management of Dushta Pratisyaya 
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 Dhanya Raj 
Designation  PhD scholar 
Affiliation  Parul Institute of Ayurved  
Address  Room no.103, Department of Kaumarabhritya, Parul Institute of Ayurved, Waghodia, Vadodara, Gujarat

Vadodara
GUJARAT
365601
India 
Phone  09656789584  
Fax    
Email  dr.dhanyalal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swapnil Raskar 
Designation  Professor and Head 
Affiliation  Parul Institute of Ayurved  
Address  Room no.103, Department of Kaumarabhritya, Parul Institute of Ayurved, Waghodia, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9879340491  
Fax    
Email  neonatecare22@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swapnil Raskar 
Designation  Professor and Head 
Affiliation  Parul Institute of Ayurved  
Address  Room no.103, Department of Kaumarabhritya, Parul Institute of Ayurved, Waghodia, Vadodara, Gujarat


GUJARAT
391760
India 
Phone  9879340491  
Fax    
Email  neonatecare22@gmail.com  
 
Source of Monetary or Material Support  
Parul Institute of Ayurved, Limda. P.O, Waghodia, Vadodara, Gujarat. Pin - 391760, India 
 
Primary Sponsor  
Name  Parul Institute of Ayurved Vadodara 
Address  Parul Institute of Ayurved, Limda.P.O, Waghodia, Vadodara, Gujarat, India. Pin - 391760 
Type of Sponsor  Private 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 Dhanya Raj  Parul Institute of Ayurved   Room no.103, Department of Kaumarabhritya, Parul Institute of Ayurved, Waghodia, Vadodara
Vadodara
GUJARAT 		 09656789584

dr.dhanyalal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul Institute of Ayurved   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J329||Chronic sinusitis, unspecified. Ayurveda Condition: DUSHTAPRATISYAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: DHARVYADI ARKA NASAL DROP , Reference: NA, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1. Patients presenting with signs and symptoms of Sinusitis and fulfilling the American Academy of Otolaryngology Head & Neck Surgery (AAO-HNS)- criteria for Sinusitis.
2. Patients who fulfilled the criteria and were willing to give written informed consent for the participation. 
 
ExclusionCriteria 
Details  1. Patient not willing for trial
2. Patient below 8 year and above 16 years
3. Patient who need surgical and other intervention (polyp)
4. Chronic debilitating infectious diseases 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in Nasasrava, Nasavarodha, Sirashoola and Mukha daurgandhya  14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Anteriour Rhinoscopy examination (Rt & Lf maxillary sinus and Frontal sinus) as well as Postnasal drip   14 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   16/12/2024 
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="0"
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-identification.

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

  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 - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 21-01-2027 and end date provided 31-12-2027?
    Response (Others) -  one year post publication

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The aim of the study is to evaluate the effect of Dharvyadi arka nasal drops in the management of Dushta Pratisyaya in children. The children with symptoms of dushta pratisyaya within the age group of 8 to 16 years will be recruited into the study based on the inclusion as well as exclusion criteria. The subjects will be administered with Darvyadi nasal drops in a dose of two drops in each nostril twice daily on empty stomach for a period of 7 days. The subjects will be followed for a period os another 7 days post intervention of 7 days. The subjects will be assessed for changes in Nasasrava, Nasavarodha, Shirashool and Mukhadaurgandhya as well as the changes in anterior rhinoscopic examination and postnasal drip. The assessment will be carried out on 0th day, 8th day and 15th day.  
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