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CTRI Number  CTRI/2024/01/061049 [Registered on: 02/01/2024] Trial Registered Prospectively
Last Modified On: 29/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of Pippalyadi Avapida Nasya followed by Anutaila Pratimarsha Nasya in Pratishyaya (Chronic Rhinosinusitis). 
Scientific Title of Study   Randomized controlled clinical evaluation of Pippalyadi Avapida Nasya followed by Anutaila Pratimarsha Nasya in Pratishyaya with special reference to 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  Ashutosh Kumar Maurya 
Designation  3rd Professional BAMS Student 
Affiliation  North Eastern Institute of Ayurveda and Homoeopathy  
Address  Room number 41 Department of Panchakarma College of Ayurveda North Eastern Institute of Ayurveda and Homoeopathy Shillong
Mawdiangdiang Shillong 793018
East Khasi Hills
MEGHALAYA
793018
India 
Phone  8299655572  
Fax    
Email  ashutoshm57@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Abhishek Bhattacharjee 
Designation  Assistant Professor 
Affiliation  North Eastern Institute of Ayurveda and Homoeopathy 
Address  Room number 41 Department of Panchakarma College of Ayurveda North Eastern Institute of Ayurveda and Homoeopathy Shillong
Mawdiangdiang Shillong Meghalaya
East Khasi Hills
MEGHALAYA
793018
India 
Phone  8876059293  
Fax    
Email  drabhishekb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vijay Kumar 
Designation  Assistant Professor 
Affiliation  North Eastern Institute of Ayurveda and Homoeopathy 
Address  Room Number 05 Department of Swasthavrita and Yoga College of Ayurveda North Eastern Institute of Ayurveda and Homoeopathy Shillong
Mawdiangdiang shillong Meghalaya
East Khasi Hills
MEGHALAYA
793018
India 
Phone  8876059293  
Fax    
Email  uccashutoshm57@gmail.com  
 
Source of Monetary or Material Support  
North Eastern Institute of Ayurveda and Homoeopathy, Shillong 
 
Primary Sponsor  
Name  North Eastern Institute of Ayurveda and Homoeopathy Ministry of Ayush Govt 
Address  North Eastern Institute of Ayurveda and Homoeopathy Mawdiangdiang Shillong Meghalaya Pin code-793018 
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 Abhishek Bhattacharjee  North Eastern Institute of Ayurveda and Homoeopathy  Room number 06 Department of Panchakarma Ayurveda Hospital North Eastern Institute of Ayurveda and Homoeopathy Shillong
East Khasi Hills
MEGHALAYA 		 08876059293

drabhishekb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-North Eastern Institute of Ayurveda and Homoeopathy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-3.5% hypertonic saline solution3.5% hypertonic saline (NaCl) solution
2Comparator Arm (Non Ayurveda)-3.5% hypertonic saline solution3.5% hypertonic saline (NaCl) solution
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient who are willing to participate in the study and ready to give a written informed consent.
2. Subjects of either sex in the age group of 18 to 60 years.
3. Patients who are having the clinical signs and symptoms of Pratishyaya.
4. Patients fulfilling the criteria of chronic rhinosinusitis as per American Academy of Otolaryngology—Head and Neck Surgery (2015).
 
 
ExclusionCriteria 
Details  1. Patient with migraine, tension type of headache, cluster headache, glaucoma or any other type of headache, except sinusitis.
2. Patients with space occupying lesion of brain.
3. Patients with nasal polyp, deviated nasal septum or any benign or malignant growth of nose and paranasal sinuses.
4. Known patient of epilepsy, mental disorder, malignancy, serious acute organic disease, or any serious comorbidity that will make it impossible to participate in the trial interventions.
5. Pregnant or lactating women.
6. Patients with contraindication of nasya karma.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Classical parameters of Pratishyaya
2. Sino-Nasal Outcome Test - 22 (SNOT-22) questionnaire score
3. Sino-Nasal Outcome Test - 20 (SNOT-20) questionnaire score
4. Sinus Control Test (SCT)
5. Haziness over the PNS (Maxillary sinuses) in X-Ray PNS water’s view
6. Haziness over the frontal sinuses in X-Ray Skull Caldwell view
7. Erythrocyte Sedimentation Rate (ESR)
8. C-Reactive Protein (CRP)
 		 Base line
15th day
30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse effect of the treatment  after treatment 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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)   09/01/2024 
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="4"
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 - NO
Brief Summary  

        Present study is a randomized, two parallel arm interventional comparative clinical trial of 30 days duration. In this study the effectiveness of Pippalyadi avapida nasya followed by Anutaila pratimarsha nasya will be compared to hypertonic saline solution (3.5 % NaCl) nasal drop in Pratishyaya. Evaluation assessments will be done at base line (0-day), 15th day and 30th day (completion).

 
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