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CTRI Number  CTRI/2025/09/094259 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 02/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative Clinical Study On Chitraka Haritaki Avleha And Pathaadi Tail Nasya In Dushta Pratishyaya (Chronic Rhinosinusitis) 
Scientific Title of Study   A Comparative Clinical Study On Chitraka Haritaki Avleha And Pathaadi Tail Nasya In Dushta Pratishyaya (Chronic Rhinosinusitis) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vidhi Arora 
Designation  PG Scholar ( Shalakya Tantra) 
Affiliation  Rishikul Campus, Uttarakhand Ayurved University (Dehradun) 
Address  OPD No.5, P.G. Department Of Shalakya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University (Dehradun)
OPD No.5, P.G. Department Of Shalakya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University (Dehradun)
Hardwar
UTTARANCHAL
249401
India 
Phone  8218064313  
Fax    
Email  yashpalarora72@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Kumar 
Designation  Assistant Professor (Shalakya Tantra) 
Affiliation  Rishikul Campus, Uttarakhand Ayurved University (Dehradun) 
Address  OPD No.5, P.G. Department Of Shalakya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University (Dehradun)
OPD No.5, P.G. Department Of Shalakya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University (Dehradun)
Hardwar
UTTARANCHAL
249401
India 
Phone  9634918909  
Fax    
Email  drarun2004@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vidhi Arora 
Designation  PG Scholar ( Shalakya Tantra) 
Affiliation  Rishikul Campus, Haridwar, Uttarakhand Ayurved University (Dehradun) 
Address  OPD No.5, P.G. Department Of Shalakya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University (Dehradun)
OPD No.5, P.G. Department Of Shalakya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University (Dehradun)
Hardwar
UTTARANCHAL
249401
India 
Phone  8218064313  
Fax    
Email  yashpalarora72@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus, Haridwar, Uttarakhand Ayurved University (Dehradun) 
 
Primary Sponsor  
Name  Uttarakhand Ayurved University Dehradun 
Address  Uttarakhand Ayurved University Station Road, Harrawala, Dehradun-248001 Uttarakhand, India 
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 VIDHI ARORA  RISHIKUL AYURVEDIC HOSPITAL, HARIDWAR  OPD NO.5, P.G. DEPARTMENT OF SHALAKYA TANTRA, RISHIKUL CAMPUS, HARIDWAR, UTTARAKHAND AYURVED UNIVERSITY (DEHRADUN)
Hardwar
UTTARANCHAL 		 8218064313

yashpalarora72@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar  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
1Comparator ArmProcedure-MARSHA NASYA (Procedure Reference: CHARAKA CHIKITSASTHAN CHAPTER 26, Procedure details: 3 SITTINGS WITH GAP INTERVAL OF 7 DAYS)
(1) Medicine Name: PATHAADI TAIL, Reference: CHARAKA CHIKITSASTHAN CHAPTER 26, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 06(drops), Frequency: od, Duration: 21 Days
2Intervention ArmDrugClassical(1) Medicine Name: CHITRAKA HARITAKI AVLEHA, Reference: BHAISHAJYA RATNAVALI NASAROGADHAYA 63, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -WARM WATER OR WARM MILK), Additional Information: NIL
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The Patients are presenting with classical features of dushta pratishyaya ( chronic rhinosinusitis) after proper screening with the help of torch light examination, anterior rhinoscopy and posterior rhinoscopy will be selected irrespective of sex, occupation, religion, etc.
1. patients having signs and symptoms of chronic rhinosinusitis and dushta pratishyaya
2. 3 episodes of rhinosinusitis once in a year will be taken into consideration for chronic rhinosinusitis
3. patients having chronicity more than 4 months
 
 
ExclusionCriteria 
Details  1. Patients having chronicity more than 5 yrs.

2. Patients having systemic complaints like bronchial asthma, serous otitis media etc.

3. Patients having local complaints like nasal polyps, malignancy etc.

4. Patients having other allergic disorder.

5. Known cases of Chronic systemic diseases like- DM, HTN, Tuberculosis, Lower respiratory tract diseases. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A COMPARATIVE CLINICAL STUDY ON CHITRAKA HARITAKI AVLEHA AND PATHAADI TAIL NASYA ON DUSHTA PRATISHYAYA (CHRONIC RHINOSINUSITIS)
Subjectively all signs & symptoms are given with grading depending upon their severity. 		 30 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
A COMPARATIVE CLINICAL STUDY ON CHITRAKA HARITAKI AVLEHA AND PATHAADI TAIL NASYA ON DUSHTA PRATISHYAYA (CHRONIC RHINOSINUSITIS)
Subjectively all signs & symptoms are given with grading depending upon their severity. 		 THIRTY 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)   06/10/2025 
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="1"
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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  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 (Others) -  RESEARCH ARTICLES, THESIS

  6. For how long will this data be available start date provided 10-09-2026 and end date provided 02-01-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   THIS STUDY IS AN OPEN RANDOMISED COMPARATIVE CLINICAL STUDY ON CHITRAKA HARITAKI AVLEHA AND PATHAADI TAILA NASYA  IN DUSHTA PRATISHYAYA (CHRONIC RHINOSINUSITIS). THIS STUDY WILL BE CONDUCTED ON 40 RANDOMLY SELECTED PATIENTS FROM OPD/IPD OF SHALAKYA TANTRA DEPARTMENT OF RISHIKUL AYURVEDIC HOSPITAL, RISHIKUL CAMPUS, HARIDWAR, UTTARAKHAND AYURVED UNIVERSITY. PATIENTS WILL BE DIVIDED INTO 2 GROUPS- 20 PATIENTS WILL BE ADMINISTERED CHITRAKA HARITAKI AVLEHA (ORAL ) & 20- PATIENTS  WIL BE ADMINISTERED FOR CHITRAKA HARITAKI AVLEHA  (ORAL) AND PATHAADI TAILA NASYA  BOTH. IN BOTH GROUPS CHITRAKA HARITAKI AVLEHA IS COMMON FOR ORAL  ADMINISTRATION FOR 30 DAYS. FOLLOW UP STUDY WILL BE CONDUCTED FOR 1 MONTH (15 DAYS INTERVAL). AFTER COMPLETION OF TREATMENT ASSESSMENT WILL BE DONE ON THE BASIS OF SUBJECTIVE & OBJECTIVE PARAMETERS AS DISCUSSED EARLIER. 
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