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CTRI Number  CTRI/2022/03/040984 [Registered on: 10/03/2022] Trial Registered Prospectively
Last Modified On: 02/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   EFFECT OF PIPALYADI AVPEEDA NASYA IN MANAGEMENT OF DUSHTA PRATISHYAYA(CHRONICRHINOSINUSITIS) 
Scientific Title of Study   A RANDOMIZED CONTROLLED CLINICAL TRIAL ON EFFECT OF PIPALYADI AVPEEDA NASYA IN MANAGEMENT OF DUSHTA PRATISHYAYA W.S.R CHRONIC RHINOSINUSITIS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nidhi Puniya 
Designation  Post Graduate Scholar 
Affiliation  V.Y.D.S. Ayurveda Mahavidyalaya  
Address  PG Department Of Panchkarma,VYDS Ayurveda Mahavidyalaya,khurja, bulandshahar
PG Department Of Panchkarma,VYDS Ayurveda Mahavidyalaya,khurja, bulandshahar
Bulandshahar
UTTAR PRADESH
203131
India 
Phone  9711992793  
Fax    
Email  nidhipuniya17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Girish narayan rai 
Designation  PROFESSOR & HEAD 
Affiliation  V.Y.D.S. Ayurveda Mahavidyalaya  
Address  P.G. Dept. Of Panchkarma V.Y.D.S. Ayurveda Mahavidyalaya ,khurja, bulandshahar
khurja, bulandshahar
Bulandshahar
UTTAR PRADESH
203131
India 
Phone  8218680766  
Fax    
Email  Girishnarayanrai@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nidhi Puniya 
Designation  Post Graduate Scholar 
Affiliation  V.Y.D.S. Ayurveda Mahavidyalaya  
Address  P.G. Dept. Of Panchkarma V.Y.D.S. Ayurveda Mahavidyalaya ,khurja, bulandshahar
khurja, bulandshahar
Bulandshahar
UTTAR PRADESH
203131
India 
Phone  9711992793  
Fax    
Email  nidhipuniya17@gmail.com  
 
Source of Monetary or Material Support  
PG Department Of Panchkarma,VYDS Ayurveda Mahavidyalaya,khurja, bulandshahar 
 
Primary Sponsor  
Name  VAIDYA YUG DUTT SHARMA AYURVEDA MAHA VIDAYALAYA 
Address  PG Department Of Panchkarma,VYDS Ayurveda Mahavidyalaya,khurja, bulandshahar 
Type of Sponsor  Private medical college 
 
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 Nidhi puniya  v.y.d.s ayurveda mahavidyalaya, khurja  PG Department Of Panchkarma,VYDS Ayurveda Mahavidyalaya,khurja, bulandshahar
Bulandshahar
UTTAR PRADESH 		 9711992793

nidhipuniya17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalya Etheical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: DUSHTAPRATISYAYAH, (2) ICD-10 Condition:6||Extracorporeal or Systemic Therapies. Ayurveda Condition: DUSHTAPRATISYAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: AYURVEDA, Procedure details: ABHAYANGA ABOVE NECK - 30MINS/ SITTING MILD NADI SWEDA ABOVE NECK - 15MINS/SITTING DRUG ADMINSTRATION - 8-8 DROPS EACH NOSTRIL/SITTING DHOOMPANA - 10MINS/SITTING)
(1) Medicine Name: PIPLAYADI AVPEEDA, Reference: CLASSICAL TEXTS SUSHRUTA, Route: Nasal, Dosage Form: Swaras/ Juice, Dose: 8(drops), Frequency: od, Duration: 4 Weeks
2Comparator ArmDrugClassical(1) Medicine Name: KATPHAL CHURANA, Reference: CLASSICAL LITERATURE, Route: Nasal, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.known case of chronic rhinosinusitis
2.patient fit for nasya karma as per ayurved

 
 
ExclusionCriteria 
Details  patients with nasal polyp and dns are excluded
chronic debilitating infectious diseases
history of hypertension or diabetes mellitus 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Piplayadi nasya relieves dushtpratishayaya   after 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
symptoms relieved and no reoccurance  8 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   11/03/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nidhipuniya17@gmail.com].

  6. For how long will this data be available start date provided 01-09-2022 and end date provided 31-08-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Trial is to conducted to know and register efficacy of avpeed nasya in Dushtpratishayaya (chronic rihnosinusitis) for a 4 weeks and to know the efficacy between two drugs 
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