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CTRI Number  CTRI/2021/01/030269 [Registered on: 06/01/2021] Trial Registered Prospectively
Last Modified On: 12/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   An Ayurvedic Management of Allergic Rhinitis 
Scientific Title of Study   A Study To Evaluate The Efficacy Of Patu Vyoshadi Sukhambu Nasya and Vyaghradi Kashaya in Kaphaja Prathishyaya 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR HARIKRISHNAN N MENON 
Designation  PG SCHOLAR 
Affiliation  GOVERNMENT AYURVEDA MEDICAL COLLEGE, BANGALORE 
Address  DEPARTMENT OF PG STUDIES IN SHALAKYA TANTRA, SHALAKYA TANTRA OPD, ROOM NO.11, GOVERNMENT AYURVEDA MEDICAL COLLEGE,DHANVANTARI ROAD,BANGALORE-560009
DEPARTMENT OF PG STUDIES IN SHALAKYA TANTRA, SHALAKYA TANTRA OPD, ROOM NO.11, GOVERNMENT AYURVEDA MEDICAL COLLEGE,DHANVANTARI ROAD,BANGALORE-560009
Bangalore
KARNATAKA
560009
India 
Phone  9605885734  
Fax    
Email  nandakumarmenon56@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DRSMPASHA 
Designation  H.O.D & ASSISTANT PROFESSOR 
Affiliation  GOVERNMENT AYURVEDA MEDICAL COLLEGE, BANGALORE 
Address  DEPARTMENT OF PG STUDIES IN SHALAKYA TANTRA, SHALAKYA TANTRA OPD, ROOM NO.11, GOVERNMENT AYURVEDA MEDICAL COLLEGE,DHANVANTARI ROAD,BANGALORE-560009
DEPARTMENT OF PG STUDIES IN SHALAKYA TANTRA, SHALAKYA TANTRA OPD, ROOM NO.11, GOVERNMENT AYURVEDA MEDICAL COLLEGE,DHANVANTARI ROAD,BANGALORE-560009
Bangalore
KARNATAKA
560009
India 
Phone  9886593932  
Fax    
Email  smpasha78@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR HARIKRISHNAN N MENON 
Designation  PG SCHOLAR 
Affiliation  GOVERNMENT AYURVEDA MEDICAL COLLEGE, BANGALORE 
Address  DEPARTMENT OF PG STUDIES IN SHALAKYA TANTRA, SHALAKYA TANTRA OPD, ROOM NO.11, GOVERNMENT AYURVEDA MEDICAL COLLEGE,DHANVANTARI ROAD,BANGALORE-560009
DEPARTMENT OF PG STUDIES IN SHALAKYA TANTRA, SHALAKYA TANTRA OPD, ROOM NO.11, GOVERNMENT AYURVEDA MEDICAL COLLEGE,DHANVANTARI ROAD,BANGALORE-560009
Bangalore
KARNATAKA
560009
India 
Phone  9605885734  
Fax    
Email  nandakumarmenon56@gmail.com  
 
Source of Monetary or Material Support  
DR HARIKRISHNAN N MENON. SRI JAYACHAMARAJENDRA INSTITUTE OF INDIAN MEDICINE HOSPITAL, GOVERNMENT AYURVEDA MEDICAL COLLEGE CAMPUS, BANGALORE 
 
Primary Sponsor  
Name  DR HARIKRISHNAN N MENON 
Address  PG SCHOLAR, DEPARTMENT OF PG STUDIES IN SHALAKYA TANTRA, SHALAKYA TANTRA OPD, ROOM NO.11,GOVERNMENT AYURVEDA MEDICAL COLLEGE, BANGALORE-560009 
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 
DRHARIKRISHNANNMENON  SRI JAYACHAMARAJENDRA INSTITUTE OF INDIAN MEDICINE HOSPITAL  SHALAKYA TANTRA OPD, ROOM NO.11. GOVERNMENT AYURVEDA MEDICAL COLLEGE, CAMPUS, DHANVANTARI ROAD BANGALORE-560009
Bangalore
KARNATAKA 		 9605885734

nandakumarmenon56@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, GOVERNMENT AYURVEDA MEDICAL COLLEGE, BANGALORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: KAPAJA-PRATISYAYAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.PATU VYOSHADI SUKHAMBU NASYA 2.VYAGHRADI KASHAYA   1.PATU VYOSHADI SUKHAMBU NASYA 6 DROPS, 2 SITTINGS OF NASYA FOR 7 DAYS WITH A GAP OF 14DAYS. 2.VYAGHRADI KASHAYA 20ML. TWICE A DAY INTERNALLY FOR 28 DAYS. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ALLERGIC RHINITIS UNSPECIFIED 
 
ExclusionCriteria 
Details  1.SUBJECTS CONTRAINDICATED FOR NASYAKARMA
2. SUBJECTS SUFFERING FROM OTHER SYSTEMIC AND INFECTIOUS DISEASE LIKE UNCONTROLLED DIABETES, HTN, TB, HIV SHALL BE EXCLUDED
3. SUBJECTS SUFFERING WITH POLYPS, DNS REQUIRING SURGICAL INTERVENTION
4. PREGNANT AND LACTATING WOMEN
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) ABSOLUTE EOSINOPHIL COUNT (AEC)400cells/µL
2) ERYTHROCYTE SEDIMENTATION RATE (ESR)20mm/hr

 		 58 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
ASSESSED USING ‘TOTAL NASAL SYMPTOM SCORE’
1) NASAL DISCHARGE
2) ITCHING IN NOSE, EYES AND PHARYNX
3) NASAL OBSTRUCTION
4) HEAVINESS OF HEAD
5) SNEEZING
6) COUGH
7) OEDEMA AROUND EYELIDS
 		 58 DAYS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/01/2021 
Date of Study Completion (India) 07/05/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 07/05/2021 
Estimated Duration of Trial   Years="0"
Months="2"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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) -  nandakumarmenon56@gmail.com

  6. For how long will this data be available start date provided 20-07-2021 and end date provided 21-07-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Prathishyaya is one among the common diseases affecting respiratory system. Kaphaja prathishyaya is characterised by snigdha Shukla kapha sruthi, Kandu in nasa thalu gala,  shiro guruthva, shoonakshi, kasa. 

Based on  above symptoms it can be compared with Allergic Rhinitis (ICD-J30.2,J30.89). It is a disorder of nose induced by an IgE mediated inflammation after Allergen exposure leading to Rhinorrhea, nasal pruritus, bilateral nasal stuffiness associated with cough, chest tightness. Worldwide it effects between 10-25%  of the population. In India it constitutes more than 50% of all allergies, 20 -30% people  suffer from it, and are prone to bronchial asthma in later stage.

In conventional medicinal system it is treated with antihistamines, nasal decongestants, corticosteroids, topical steroids which causes different side effects like drowsiness, rhinitis medicamentosa, mucosal atrophy, several systemic disorders etc.By considering these facts there is a need to develop a treatment which aims at reducing symptoms and improving immunity to overcome this condition.

 Nasya is a line of treatment for most of the urdhwa jatru vikaras. In kaphaja prathishyaya, nasya with theekshna dravyas can give positive results hence Patu vyoshadi sukhambu nasya  is taken. It can improve nasal mucosa function by direct cleansing, removal of inflammatory mediators and enhancing mucociliary function.  Vyaghradi Kashaya is taken, as the drugs mentioned in this yoga is theekshna, ushna and rooksha which act as kapha hara. They are also cost effective and easily available.Considering above facts these yoga’s are expected to yield better results, hence the present study has been taken.

HYPOTHESIS

NULL HYPOTHESIS:

H0: There is no effect of patu vyoshadi sukhambu  nasya and Vyaghradi Kashaya  internally in kaphaja prathishyaya

                                             

ALTERNATE HYPOTHESIS:

H1: There is a significant effect of Patu vyoshadi sukhambu nasya and Vyaghradi Kashaya internally in kaphaja prathishyaya.


 
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