| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J329||Chronic sinusitis, unspecified. Ayurveda Condition: DUSHTAPRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (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 |
|
|
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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 |
|
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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. |