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CTRI Number  CTRI/2023/06/053744 [Registered on: 09/06/2023] Trial Registered Prospectively
Last Modified On: 01/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Trial To Evaluate The Effect Of Pathadi Taila Nasya And Mandukaparnyaadi Kwatha In The Management Of Vataja(Allergic Rhinitis) 
Scientific Title of Study   A Clinical Trial To Evaluate The Effect Of Pathadi Taila Nasya and Mandukaparniyaadi Kwatha In The Management Of Vataja Pratishyaya(Allergic Rhinitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nill  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr IRAFAN KHAN 
Designation  PG SCHOLAR 
Affiliation  SJGAMCH 
Address  SHREE JAGDGURU GAVISIDDESHWARA AYURVEDA MEDICAL COLLEGE AND HOSPITAL

Koppal
KARNATAKA
583231
India 
Phone  7353171615  
Fax    
Email  dr.irfankhanpathan171615@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Radhika Injamuri 
Designation  Associated professor,Department of Kaumarabhritya 
Affiliation  SJGAMCH 
Address  Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College And Hospital,Koppal

Koppal
KARNATAKA
583231
India 
Phone  9108304745  
Fax    
Email  raadhika17@outlook.com  
 
Details of Contact Person
Public Query  
Name  Dr Irafan khan 
Designation  PG Scholar 
Affiliation  SJGAMCH 
Address  Shree Jagdguru Gavisiddheshwara Ayurvedic Medical College and Hospital,Koppal Room No:13 Kaumarabhritya OPD

Koppal
KARNATAKA
583231
India 
Phone  7353171615  
Fax    
Email  dr.irfankhanpathan171615@gmail.com  
 
Source of Monetary or Material Support  
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College And Hospital,Koppal,Karanataka 
 
Primary Sponsor  
Name  Dr Irafan khan 
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital,Koppal,Karanataka 
Type of Sponsor  Other [Self Sponsor] 
 
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 Irafan khan  Shree Jagadguru Gavisiddeshwara Ayurveda Medical College & Hospital  Shree Jagadguru Gavisiddeshwara Ayurveda Medical College & Hospital Kaumarabhritya OPD Room No:13 Koppal Karanataka
Koppal
KARNATAKA 		 7353171615

dr.irfankhanpathan171615@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SJGAMC&H/IEC/727/2021  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
1Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: charaka samhita, Procedure details: shodhana nasya is given mukha abhyanga and mridu swedana done befor nasya nasya will be given . dosage will be selected according to age.)
(1) Medicine Name: mandukaparnyaadi kwatha, Reference: VaidhikiyaShabdasindu madhyama khandha patal, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 14(ml), Frequency: bd, Duration: 14 Days
2Comparator Arm (Non Ayurveda)-Antihistamine drugTo Assessing Parameters Like Nasal congestion ,Sneezing ,Rhinorrhea, Itching of Allergic Rhinitis with Existing chlorpheniramine Maleate
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Children with sign and symptoms of vatajaPratishyaya(allergic rhinitis) aged
between “3 to 16years”of either gender with the recent onset within one week or
less than one week. 
 
ExclusionCriteria 
Details  Children diagnosed with other types of dushtapratishyaya
,Raktapratishyayaandsannipatajapratishyaya.
• Chronic sinusitis,asthma,infectious diseases like TB and other systemic disorder
which interfere in the cause 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 
To asses Nasal congestion,Rhinorrhea,  3months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess sneezing,Nasal itching  3months 
 
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)   11/06/2023 
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   None Yet 
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 [dr.irfankhanpathan171615@gmail.com].

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2029?
    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   Treatment of allergic rhinitis is symptomatic and most of the drugs are having antihistamine property and mast cell stabilizers but root cause will not be treated. In Ayurveda treatment of allergic rhinitis is aimed to treat not only the symptoms but also to treat the disease from its root
Vataja pratishyaya is common among the pratishyaya in children. Pathaditaila explained in charaka samhita chikitsa Sthana is having ingredients likePatha, Haridra, Daruharidra, Moorva, Pippali, Jatipallava, Tilataila, helps in reducing vataand kaphadosha vitiation . And also Mandukaparnyaadi kwatha for internal medication with the ingredients Mandukaparni ,Maricha,kulatta,may relieve the above symptoms .Hence an attempt is made to “evaluate the effect of pathaditaila nasya and mandukaparnyaadi kwatha in the management of Allergic rhinitis and it will be compared with “chlorpheniramine maleate” a proved drug for its anti-histamine effect.
 
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