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CTRI Number  CTRI/2024/06/068264 [Registered on: 03/06/2024] Trial Registered Prospectively
Last Modified On: 31/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of pippalyadi avapeeda nasya in chronic rhinosinusitis 
Scientific Title of Study   Effect of pippalyadi avapeeda nasya in chronic rhinosinusitis - a pre and post interventional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rekhanath K C 
Designation  Pg scholar 
Affiliation  Govt ayurveda college, Kannur 
Address  OPD NO 8 Department of Salakyatantra Government ayurveda college,Kannur Pariyaram Kerala India

Kannur
KERALA
670503
India 
Phone  8547090031  
Fax    
Email  rekhanathkc11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr VKV Balakrishnan  
Designation  Professor and HOD  
Affiliation  Govt ayurveda college, Kannur 
Address  Department of salakyatantra Govt ayurveda college, Kannur

Kannur
KERALA
670502
India 
Phone  9447037892  
Fax    
Email  baluvkv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr VKV Balakrishnan  
Designation  Professor and HOD  
Affiliation  Govt ayurveda college, Kannur 
Address  Department of salakyatantra Govt ayurveda college, Kannur

Kannur
KERALA
670502
India 
Phone  9447037892  
Fax    
Email  baluvkv@gmail.com  
 
Source of Monetary or Material Support  
Department of Salakyatantra Government ayurveda college, Kannur , Pariyaram Kerala Pin - 670503 Kerala India 
 
Primary Sponsor  
Name  Rekhanath K C 
Address  Pg scholar Govt ayurveda college, Kannur Pariyaram Pin - 670503 Kerala 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 Rekhanath K C  Government ayurveda college ,Kannur  OPD NO 8 Department of Salakyatantra Government ayurveda college,Kannur Pin - 670503 Pariyaram Pin - 670503
Kannur
KERALA 
8547090031

rekhanathkc11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Government ayurveda college Kannur   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 ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtanga Hrdaya , Sootrasthana, updated third edition, Chapter 20 , page no 113 - 114, Procedure details: POORVA KARMA The research participant is subjected to sthanika abyanga & nadisveda. Eyes are bandaged with clean gauze piece and cotton pad over closed eyelids while doing svedana. Then made to lie in supine position with slightly elevated legs and head extended backwards. PRADHANA KARMA The measured dose of medicine, taken in a gokarna is made lukewarm by placing it over boiled water and poured into either nostril closing the other in a continuous single stream. Immediately after instillation of medicine, mild massage is done over soles, palm, shoulder, neck, forehead and ears.Subject is asked to inhale the medicine with moderate force and spit it through mouth turning head to either side alternatively without rising from the cot. PASCHAT KARMA Kabala with lukewarm water)
(1) Medicine Name: pippali and saindhavam, Reference: Sarangadhara Samhitha, Route: Nasal, Dosage Form: Swaras/ Juice, Dose: 3(ml), Frequency: od, Duration: 5 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects presenting with signs and symptoms of chronic rhinosinusitis with chronicity of 12 weeks or more. 
 
ExclusionCriteria 
Details  Subjects contraindicated for nasya karma
Diagnosed cases of TB, complications of sinusitis
Diseases which require surgical interventions like DNS and nasal polyp 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
reduction in Nasal obstruction, nasal discharge, post nasal drip, headache and diminished sense of smell   0th day, 6th day, 15th day,30thday 
 
Secondary Outcome  
Outcome  TimePoints 
Not aplicable  Not aplicable  
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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 
Date of First Enrollment (India)   12/06/2024 
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="3"
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   Chronic rhinosinusitis is a chronic inflammatory disease of nasal and paranasal sinus mucosa where symptomatology has continued beyond 12 weeks. Earlier the term sinusitis was used to describe 
the inflammation of the mucosa of sinuses. However, as this condition is invariably associated with inflammation of the nasal mucosa, the term rhinosinusitis has been preferred. Clinical features of 
chronic rhinosinusitis include nasal obstruction, nasal or postnasal purulent discharge, facial pain, disturbance of smell, headache etc. 
In ayurvedic classics, signs and symptoms of chronic rhinosinusitis can be corelated to dustapratisyaya. If any pratisyaya left untreated, it may progress into dustapratisyaya and finally leads to kshaya. Therefore, prevention of this progression is necessary. Theekshna virechana nasya like Avapeeda and Pradhamana are effective in eliminating the aggravated doshas from shiras. Pippalyadi
avapeeda nasya is mentioned in Sarangadhara Samhitha, uttarakhanda, nasyavidhi adhyaya. This yoga contains pippali and saindhava. Pippali has kapha nirharatwa property and saindhava enhances the bioavailability of pippali.Chronic rhinosinusitis is a public health problem that has a significant socio-economic impact. Moreover, the complexity of this disease is due to its heterogenous nature based on underlying pathophysiology. Chronic rhinosinusitis affects 1 in 8 people in India; about 5-15% of urban population. The prevalence of rhinosinusitis has been reported to exceed that of any other chronic condition and is apparently on increase. Despite being wide spread, little is known about etiology of chronic rhinosinusitis. Contemporary management has been focused on relieving symptoms. First line of treatment is nasal saline irrigation and intranasal corticosteroid sprays. Functional endoscopic sinus surgery can be considered for patients who fail medical management. In this condition we can opt an alternate management with the formulations in ayurvedic classics. All ingredients in this formulation are easily available and cost effective. Hence this study is designed to find out the effect of Pippalyadi avapeeda nasya in the management of chronic rhinosinusitis. 
 
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