FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/03/050540 [Registered on: 10/03/2023] Trial Registered Prospectively
Last Modified On: 09/03/2023
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 the efficacy of Ashwagandhadi Ghrita Nasya with Fluticasone Propionate nasal spray in Allergic Rhinitis 
Scientific Title of Study   A randomised controlled trial of Ashwagandhadi Ghrita Nasya and Fluticasone Propionate nasal spray in the management of Vataj Pratishyaya (Allergic Rhinitis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chiragdip Ranjitsing Deshmukh 
Designation  PG Scholar 
Affiliation  Dr. D. Y. Patil College of Ayurved & Research Centre, Pimpri  
Address  Dr. D. Y. Patil College of Ayurved & Research Centre Sant Tukaram Nagar, Pimpri, Pune MAHARASHTRA India
Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411 018
India 
Phone  7709779541  
Fax    
Email  dchirag8241@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh Rahinj 
Designation  Associate Professor 
Affiliation  Dr. D. Y. Patil College of Ayurved & Research Centre, Pimpri  
Address  Dr. D. Y. Patil College of Ayurved & Research Centre Sant Tukaram Nagar, Pimpri, Pune MAHARASHTRA India
Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India 
Phone  8600866097  
Fax    
Email  santoshrahinj@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Chiragdip Ranjitsing Deshmukh 
Designation  PG Scholar 
Affiliation  Dr. D. Y. Patil College of Ayurved & Research Centre, Pimpri  
Address  Dr. D. Y. Patil College of Ayurved & Research Centre Sant Tukaram Nagar, Pimpri, Pune MAHARASHTRA India
Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India 
Phone  7709779541  
Fax    
Email  dchirag8241@gmail.com  
 
Source of Monetary or Material Support  
Dr. D. Y. Patil college of Ayurveda and Research centre, Pimpri  
 
Primary Sponsor  
Name  Dr Chiragdip Ranjitsing Deshmukh 
Address  Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Santosh Rahinj  Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chiragdip Ranjitsing Deshmukh  Dr. D. Y. Patil college of Ayurveda and Research centre   Shalakya Tantra ENT OPD no. 4, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA 		 7709779541

dchirag8241@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR. DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J988||Other specified respiratory disorders. Ayurveda Condition: VATAJAPRATISYAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Fluticasone PropionateRoute of administration: Nasal, Dosage:2 Drops or 2 Puffs, Frequency: BD, Duration of treatment: 6 days
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charak Sidhhi sthan 9/97, Procedure details: Pratimarsha nasya is administered daily 2 drops, twice a day. Procedure: The patient is made to lie down in supine position with head and neck in lower position; instil 2 drops of oil in each nostril. Pinch the nose once and after releasing, suck the oil up. Spit the oil when it reaches the throat. ))
(1) Medicine Name: Ashwagandhadi Ghrita, Reference: Sharangdhar Samhita Uttarkhanda 1/17 & Bhavprakash Guduchyadivarga 163, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 6 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient suffering from Kshawathu( sneezing), Nasa avarodha(nasal congestion), nasa kandu(nasal itching), nasa strava(nasal discharge), shiro gaurav(heaviness in head) and shwasa kashtata( difficulty in breathing). 
 
ExclusionCriteria 
Details  1. Pregnant and lactating women
2. Patients who need surgical and other intervention
3. Patients suffering from bacterial or viral rhinitis
4. Patients suffering from severe hypertension, malignancy, uncontrolled diabetes mellitus, heart disease and bronchial asthama. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Reduced Sneezing
2. Improvement in breathing due to clearing of nasal passage.
3. Reduced Nasal itching.
4. Reduced Rhinorrhea
5. Reduced frequency of Headache. 		 Enrollment: day 0
Final follow-up: day 7  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in sleep quality  Enrollment: day 0
Final follow-up: day 7  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/04/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Vataja Pratishyaya (Allergic Rhinitis) is common disease in day to day practice and contemporary science does not have proper solution for treating the same. Around 80% of the patient pool coming to Otorhinolaryngologist belongs to allergic rhinitis. Treatment according to modern science is avoidance of allergens, administration of nasal decongestants, corticosteroids and antihistamines, this may relieve symptoms but may lead to certain side effects. Recurrences are quite common even after treatment. Hence effective management of allergic rhinitis is necessary. 
Nasya is the choice of treatment in Ayurveda for Vataja Pratishyaya. Ashwagandhadi Ghrita has ingredients which are found to have anti-inflammatory, analgesic, antioxidant, antihistaminic and antiallergic properties. The study is planned to develop evidence based support for Ashwagandhadi Ghrita nasya in the management of Vataja Pratishyaya .
 
Close