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CTRI Number  CTRI/2025/06/089423 [Registered on: 24/06/2025] Trial Registered Prospectively
Last Modified On: 23/06/2025
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   A Clinical Trial To Compare Effect Of Dashmool Rasayana And Chitraka Haritaki In The Management Of Vataj Pratishaya (Rhinitis) 
Scientific Title of Study   A Randomized Control Trial To Compare Efficacy Of Dashmool Rasayana And Chitraka Haritaki In The Management Of Vataj Pratishaya 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogesh Kumar Sisodiya 
Designation  PhD Scholar 
Affiliation  Tilak Ayurved Mahavidyalaya, Pune 
Address  Shalakyatantra ENT opd of Seth Tarachanad Ramnath Ayurvedic Chairatable hospital Rasta peth Pune

Pune
MAHARASHTRA
411011
India 
Phone  9557320104  
Fax    
Email  dr.yogeshsisodiya09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sangeeta S Salvi 
Designation  Professor and HOD 
Affiliation  Tilak Ayurved Mahavidyalaya Pune 
Address  Shalakya tantra depatment of Tilak Ayurved Mahavidyalaya Rasta peth Pune

Pune
MAHARASHTRA
411011
India 
Phone  9822082795  
Fax    
Email  salvisangeeta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Yogesh kumar Sisodiya 
Designation  PhD Scholar 
Affiliation  Tilak Ayurved Mahavidyalaya Pune 
Address  Shalakyatantra ENT opd of Seth Tarachanad Ramnath Ayurvedic Chairatable hospital Rasta peth Pune

Pune
MAHARASHTRA
411011
India 
Phone  9557320104  
Fax    
Email  dr.yogeshsisodiya09@gmail.com  
 
Source of Monetary or Material Support  
No funding agency is involved; the researcher will finance their study themselves.  
 
Primary Sponsor  
Name  Dr Yogesh Kumar sisodiya 
Address  Tilak Ayurved Mahavidyalaya, Rasta peth Pune Maharastra 
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 Yogesh kumar sisodiya  Tilak Ayurved Mahavidyalaya Pune  Shalakyatantra ENT opd of Seth Tarachanad Ramnath Ayurvedic Chairatable hospital Rasta peth Pune
Pune
MAHARASHTRA 		 9557320104

dr.yogeshsisodiya09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee TAMVpune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R50-R69||General symptoms and signs. Ayurveda Condition: VATAJAPRATISYAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Dashmool rasayan , Reference: Sahastra yog, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Chitraka haritaki, Reference: Bhaishajya ratnavali Nasa rog , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients Having Sign and Symptoms of Vataj Pratishaya 
 
ExclusionCriteria 
Details  Patient not willing for written consent.
Patient suffering from any Systemic disorders like DM, HTN, HIV, HbsAg .
Patient with chronic infective respiratory disease like pneumonia etc and nasal tumors.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is improve the patient quality of life by reducing impact of disease on their daily activities   60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse reaction if any  60 days 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   03/10/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
This study is  RANDOMIZED CONTROL TRIAL TO COMPARE EFFICACY OF DASHMOOL RASAYANA AND CHITRAKA HARITAKI IN THE MANAGEMENT OF VATAJ   PRATISHAYA 
Total 150 Patients of age 15 years to 50 years of both sex will be randomly selected for this clinical trial and divided into two groups
Group A –  Total 75 Patients 

These patients will be treated with Dashmool rasayan

Route of administration – Rasayan sewan (Orally)

Time of administration –  Rasayan sewan kal


Group B – Total 75 Patients 

These patients will be treated with Chitraka haritaki

Route of administration –  (Orally)

Time of administration –  ( twice a day) 

Data will be analysed and appropriate statistical test will be applied

 
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