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CTRI Number  CTRI/2024/10/075406 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An ayurvedic management of sinus headache with nasal symptoms 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of pratishyayahara nasya and tulasi swarasadi taila nasya in kaphaja 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  Dr Shubha S Bhat 
Designation  Pg scholar 
Affiliation  Government ayurveda medical college bengaluru 
Address  Opd no.11 Dept of pg studies in shalakya tantra Government ayurveda medical college Dhanwantari road bengaluru

Bangalore
KARNATAKA
560009
India 
Phone  9446181103  
Fax    
Email  shubhasbhat413@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rathi S 
Designation  Professor 
Affiliation  Government ayurveda medical college bengaluru  
Address  Opd no.11 Dept of pg studies in shalakya tantra Government ayurveda medical college Dhanwantari road bengaluru

Bangalore
KARNATAKA
560009
India 
Phone  897079550  
Fax    
Email  drrathi.s@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubha S Bhat 
Designation  Pg scholar 
Affiliation  Government ayurveda medical college bengaluru 
Address  Opd no.11 Dept of pg studies in shalakya tantra Government ayurveda medical college Dhanwantari road bengaluru

Bangalore
KARNATAKA
560009
India 
Phone  9446181103  
Fax    
Email  shubhasbhat413@gmail.com  
 
Source of Monetary or Material Support  
Government ayurveda medical college Dhanwantari road Bangalore 560009 Karnataka India 
 
Primary Sponsor  
Name  Dr Shubha S bhat 
Address  Opd no 11 Department of pg studies in shalakya tantra Government ayurveda medical college bengaluru 560009 Karnataka India 
Type of Sponsor  Other [Self] 
 
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 Shubha S Bhat  Sri jayachamarajendra ayurveda and Unami hospital bang-lore  Opd no 11 department of pg studies in shalakya tantra government ayurveda medical college bengaluru
Bangalore
KARNATAKA 		 9446181103

shubhasbhat413@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Sri jayachamarajendra ayurveda and unani hospital banglore   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: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtanga hrudaya, Procedure details: One sitting of nasya karma for 7 days in morning before food with an interval of 14 days then another sitting of nasya karma for 7 days)
(1) Medicine Name: Pratishyayahara nasya, Reference: Basavarajeeyam, Route: Nasal, Dosage Form: Churna/ Powder, Dose: 0.6(mg), Frequency: od, Duration: 1 Weeks
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtanga hrudayam, Procedure details: One sitting of nasya karma for 7 days in the morning before food with an interval of 14 days then another sitting of nasya karma for 7 days)
(1) Medicine Name: Tulasi swarasadi taila, Reference: Sahasrayogam, Route: Nasal, Dosage Form: Taila, Dose: 6(ml), Frequency: od, Duration: 1 Weeks
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Kaphaja pratishyaya lakshana are observed and included
Patient belonging to age group of 18 to 60 years
Patients selected irrespective of sex occupation and socio economic status
Those who are eligible for nasya karma
Patient with xray showing haziness in any or all of the sinuses 
 
ExclusionCriteria 
Details  Patients with any systemic illness
Patientwith complications of rhinosinusitis
Patients with nasal polyp
Patients suffering from headache which is caused due to migraine or tension or other neurological diseases 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Headache nasal obstruction X-ray waters view changes

 		 58 days 
 
Secondary Outcome  
Outcome  TimePoints 
Rhinosinusitis disability index  58 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)   26/10/2024 
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="11"
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   In Ayurvedic classics, Pratishyaya has been discussed extensively under Nasa rogas. Various types of pratishyaya has been explained by Ayurveda Acharyas. Kaphaja pratishyaya is characterized by Shukla sheeta srava from nasa, Shoonakshi, Guruta in shira and mukha and kandu in Shira, gala, talu & oshta. The common nidanas include Peete nanyena varina(Intake of different source/infected water frequently), Guru, sheeta ati sevana, Raja dhoomatisevana(Exposure to wind and dust) Rutu viparyaya(seasonal variations) etc. Most of these clinical features are correlated with signs and symptoms of Chronic Rhinosinusitis. Rhinosinusitis is an inflammation of nasal air sinuses. If the symptoms persist for more than 12 weeks, it is called as Chronic Rhinosinusitis. Rhinosinusitis affects the mucosa of nose and para nasal sinus affecting approximately 15% population in India and 12-15% general population in the world. It is seen that increased air pollution and exposure to cold and flu have caused an increase in this condition. Over 85% of people with cold develop inflamed sinus. These inflammations are typically brief & mild. Only between 0.5% and 5% people with cold develop true sinusitis. Maxillary sinusitis is most commonly seen. The complications of Chronic Rhinosinusitis include Pre-septal cellulitis, Orbital cellulitis, Cavernous sinus thrombosis etc and conservative treatment is indicated for Rhinosinusitis like Antibiotics, nasal decongestant drops, steaminhalation, analgesics. In this scenario, where there is no effective management for Rhinosinusitis in conventional system of medicine, Ayurvedic line of management may be beneficial. Acharya Sushrutha has mentioned that for any patient who is suffering from Pratishyaya, the first line of management is nothing but the Nasyakarma. It is easy to administer, cost effective, easily acceptable by patients and can be done at OPD level. Considering the above factors this study was taken up. Pratishyayahara nasya5 is used in the form of pradhamana nasya and Tulasi swarasadi taila6 is taken for nasya as drugs used in this formulation has Kaphahara property. 
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