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CTRI Number  CTRI/2023/08/055955 [Registered on: 01/08/2023] Trial Registered Prospectively
Last Modified On: 19/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic Treatment Of Allergic Rhinitis In children  
Scientific Title of Study   A Controlled Clinical Study To Evaluate The Effect Of Lavangadi Choorna Over Vyoshadi Choorna In Management Of Allergic Rhinitis (Vataja Pratishyaya ) In Children 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrShantlaxmi J N 
Designation  PG Scholar 
Affiliation  Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital 
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and hospital room no 13 kaumarbhritya OPD Gavimath campus Koppal
Department of kaumarabhritya room No 13 Koppal
Koppal
KARNATAKA
583231
India 
Phone  8904349207  
Fax    
Email  Shantlaxmin@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr G G Patil 
Designation  HOD Professor Department of Kaumarabhritya 
Affiliation  Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital 
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and hospital room no 13 kaumarbhritya OPD Gavimath campus Koppal
Room no 13,Department of kaumarbhritya OPD Gavimath campus Koppal
Koppal
KARNATAKA
583231
India 
Phone  9060896550  
Fax    
Email  gaviayu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrShantlaxmi J N 
Designation  PG Scholar 
Affiliation  Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital 
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and hospital room no 13 kaumarbhritya OPD Gavimath campus Koppal
Department of kaumarabhritya Room no 13 Koppal
Koppal
KARNATAKA
583231
India 
Phone  8904349207  
Fax    
Email  Shantlaxmin@gmail.com  
 
Source of Monetary or Material Support  
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital Koppal 
 
Primary Sponsor  
Name  Dr Shantlaxmi J N 
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and hospital room no 13 kaumarbhritya OPD Gavimath campus Koppal 
Type of Sponsor  Other [Self sponsoring] 
 
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 Shantlaxmi J N  Shree Jagadguru Gavisiddeshwara Ayurveda medical college Gavimata campus Koppal karnataka  Department of Kaumarabhritya Room no 13 Gavimath Campus Koppal karnataka
Koppal
KARNATAKA 
8904349207

shantlaxmin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Istitutional Ethical Committee clearance Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital Koppal   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: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Lavangadi Churna, Reference: Chakradatta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: vyoshadhi Churna, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Children with signs and symptoms of allergic rhinitis aged between 2 to 16 year of with the recent onset within one week irrespective of gender religion and socio economic status fullfilling the diagnostic criteria will be included for the study  
 
ExclusionCriteria 
Details  Children diagnosed with other type of dushtapratishyaya , raktaja pratishyaya and sannipataja pratishyaya
Chronic sinusitis , asthma , infectious diseases like TB and other systemic disorders which interfere in coarse of treatment 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of nasal congestion, rhinorrhea  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Sneezing,Nasal itching,Nasal congestion,Rhinorrhea  Assessed on 1st day, 30th day. 60th day 
 
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/ Phase 3 
Date of First Enrollment (India)   01/08/2023 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  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 - Anyone

  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 - Proposals should be directed to [shantlaxmin@gmail.com].

  6. For how long will this data be available start date provided 01-11-2023 and end date provided 01-11-2029?
    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  
Allergic rhinitis1 is an acute IGE mediated , hypersensitivity reaction of nasal mucosa in response to antigenic substance (allergens) associated with episodic  attacks of sneezing, watery rhinnorhea along with nasal congestion.In children it effects upto 20 to 40 %2 specially in prospective socities. Recent evidences suggest that the pervalance of disorder might be increasing day by day.  Earlier allergic rhinitis was thought to be a disease localized to nasal cavity, however current understanding suggests that often the whole airway can get involved,due to physiological, functional and immunological relationships that exists between the upper respiratory tract and lower respiratory tracts3 .General features include nasal  congestion , Itching ,sneezing,childrens often blow their nose or sniff or snort ,coughing ,may feel loss of smell etc. The line of treatment in allopathic system1,2,3 include use of antihistamines, steroids, nasal decongestents like sprays immunotherapy4 (limited) are available which are of majorly symptomatic treatment with many side effects like dryness of mouth ,irritation, drowziness, indigestion,anxiety, insomnia, heartburn5etc According to Ayurveda  it can be co-related to vataja pratishyaya in context of pratishyaya. commonly described symptoms are nasavarodha,nasa kandu, nasa srava, khavathu6,7etc  many treatment aspects with good number of shamanoushadhis have been explained,one among them is lavangadi choorna8, which act as dipana pachana, swasahara, kasahara and tridoshahara properties.this formulation is indicated in respiratory diseases like shwasa ,kasa, hikka tamakashwasa including pinasa, which is the avasta of pratishyaya itself. And it also imparts effect of rasayana9,which promotes the immunity also with   releiving the symptoms.so an attempt has made to evaluate its effect in vataja pratishyaya with respect to allergic rhinitis,in comparision to vyoshadi churna10 which has already  proved its efficacy in pratishyaya. 
 
 
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