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CTRI Number  CTRI/2024/12/078109 [Registered on: 13/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This clinical trial will be performed to understand the effect of prepared Ayurvedic medicine(lakshadi taila kapal and nasa bahya abhyanga)in vataj pratishyaya which includes symptoms like nasal congestion, nasal discharge, itching. 
Scientific Title of Study   A Randomized controlled clinical trial to evaluate the add on effect of lakshadi taila kapal and nasa bahya abhyanga with vyoshadi vati in vataj pratishyaya 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishnavi mandavkar  
Designation  PG scholar 
Affiliation  PDEAs college of Ayurved and research centre nigadi pune 
Address  PDEAs college of Ayurved and Research centre 3rd floor shalakyatantra department sector no 25 pradhikaran nigadi pune MAHARASHTRA 411044 India

Pune
MAHARASHTRA
411044
India 
Phone  8329892402  
Fax    
Email  vaishnavimandavkar82@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manisha pravin pingale 
Designation  associate professor shalakyatantra department 
Affiliation  PDEAs college of Ayurved and research centre nigadi pune 
Address  PDEAs college of Ayurved and Research centre 3rd floor shalakyatantra department sector no 25 pradhikaran nigadi pune MAHARASHTRA 411044 India

Pune
MAHARASHTRA
411044
India 
Phone  9028360353  
Fax    
Email  manishapingale999@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Vaishnavi mandavkar  
Designation  PG scholar 
Affiliation  PDEAs college of Ayurved and research centre nigadi pune 
Address  PDEAs college of Ayurved and Research centre 3rd floor shalakyatantra department sector no 25 pradhikaran nigadi pune MAHARASHTRA 411044 India

Pune
MAHARASHTRA
411044
India 
Phone  8329892402  
Fax    
Email  vaishnavimandavkar82@gmail.com  
 
Source of Monetary or Material Support  
PDEAs college of Ayurved and research centre sector no 25 pradhikaran nigadi pune 411044 
 
Primary Sponsor  
Name  PDEAs college of ayurved and research centre 
Address  PDEAs college of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran nigadi pune Maharashtra, India 411044 
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 Vaishnavi Mandavkar   Ayurveda rugnalaya and sterling multispeciality hospital nigadi Pune  Sector no. 27 Shalakyatantra OPD no. 122, pradhikaran Nigadi Pune
Pune
MAHARASHTRA 		 8329892402

vaishnavimandavkar82@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee  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: VATAJAPRATISYAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Lakshadi tail abhyanga, Reference: Sharangdhar samhita, Route: Topical, Dosage Form: Taila, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients between the age group of 18 to 60 yrs of age irrespective to genders. the patients presenting any three signs and symptoms of vataj pratishyaya- nasastrav, nasa-avrodha, pihitnasa. 
 
ExclusionCriteria 
Details  Patients having complications like Dushta-pratishyay, known case of nasal polyps. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To identify the difference of treatment for management of vataj pratishyaya. to compare effectivness of treatment over period of time. to compare the efficacy of vyoshadi vati with and without lakshadi taila kapal and nasa bahya abhyanga in vataj pratishyaya.   7 days treatment with two follow ups on 4th and 8th day 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of vyoshadi vati with lakshadi taila kapal and nasa bahya abhyanga .
to assess the effect of vyoshadi vati without lakshadi taila kapal and nasa bahya abhyanga .
to observe the adverse effect of drug if any 		 7 days treatment with two follow ups on 4th and 8th day 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   23/12/2024 
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="1"
Months="0"
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   Vataj pratishyaya is described by acharya sushruta vagbhat and charak. Due to modern civilization there is increased evidence of allergic rhinitis cases. current modern treament includes decongestants and anti allergic nasal drops which only gives symptomatic relief . lakshadi taila abhyanga can be easily administered to the patients .for effective and long standing treatment, proposing this study where we try lakshadi kapal and nasa bahya abhyanga with vyoshadi vati and to check if lakshadi taila kapal and nasa abhya abhyanga can increases the efficacy of vyoshadi vati in vataj pratishyaya when given together . 
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