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CTRI Number  CTRI/2020/04/024478 [Registered on: 07/04/2020] Trial Registered Prospectively
Last Modified On: 04/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of effectiveness of Vyoshadi Vati given with and without Surasasidhha taila nasya for 21 days in Allergic rhinitis patients.  
Scientific Title of Study   A randomized comparative clinical study to evaluate add on effect of Surasasidhha taila nasya with Vyoshadi vati in 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 Shubhangi Suresh Avhad 
Designation  PG student 
Affiliation  PDEAS College of Ayurved and Research centre, Akurdi, Pune 
Address  PDEAS College of Ayurved and Research centre, sector no. 25, nigdi pradhikaran, pune
PDEAS Ayurved Rugnalaya and sterling multi speciality hospital, sector no 27, nigdi pradhikaran, pune
Pune
MAHARASHTRA
411044
India 
Phone  8308307616  
Fax    
Email  avhad.shubhangi00@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandana Virkar 
Designation  HOD shalakyatantra 
Affiliation  PDEAS College of Ayurved and Research centre, Akurdi, Pune 
Address  PDEAS College of Ayurved and Research centre, third floor, shalakyatantra department, sector no. 25, nigdi pradhikaran, pune
PDEAS Ayurved Rugnalaya and sterling multi speciality hospital, sector no 27, nigdi pradhikaran, pune
Pune
MAHARASHTRA
411044
India 
Phone  9822199107  
Fax    
Email  virkar.chandana@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chandana Virkar 
Designation  HOD shalakyatantra 
Affiliation  PDEAS College of Ayurved and Research centre, Akurdi, Pune 
Address  PDEAS College of Ayurved and Research centre, third floor, shalakyatantra department, sector no. 25, nigdi pradhikaran, pune
PDEAS Ayurved Rugnalaya and sterling multi speciality hospital, sector no 27, nigdi pradhikaran, pune
Pune
MAHARASHTRA
411044
India 
Phone  9822199107  
Fax    
Email  virkar.chandana@gmail.com  
 
Source of Monetary or Material Support  
PDEAS college of ayurved and research centre, third floor, shalakyatantra department, sector no 25, nigdi pradhikaran, pune  
 
Primary Sponsor  
Name  Principal PDEAs college of ayurved and research centre 
Address  PDEAS college of ayurved and research centre, sector no 25, nigdi pradhikaran, pune, 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 Shubhangi Suresh Avhad  PDEAS ayurved rugnalaya and sterling multi speciality hospital, nigdi, pradhikaran, pune  Vithhal rukhmini road, sector no 27, shalakyatantra opd no 122, nigdi pradhikaran, pune, 411044
Pune
MAHARASHTRA 		 8308307616

avhad.shubhangi00@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Surasasidhha taila nasya with Vyoshadi vati  Group A will be treated with Surasasidhha taila nasya containing surasa sidhha tila taila and vyoshadi vati containing trikatu, talispatra, chavya, tittidika, amlavetas, chitrak, ajaji, twak, ela, gud, patra. Surasasidhha taila nasya will be given nasally in the dose of 2 drops once daily in morning and Vyoshadi vati will be given orally 250 mg twice a day after meal in the age group of 18 to 50 years for 21 days which includes follow up on 8th, 15th, 22nd day and 1 month after completion of treatment.  
Comparator Agent  Vyoshadi vati   Group B will be treated with Vyoshadi vati containing trikatu, talispatra, chavya, tittidik, amlavetas, chitrak, ajaji, twak, ela, gud and patra. Vyoshadi vati will be given orally 250 mg twice a day after meal in the age group of 18 to 50 years for 21 days which includes follow up on 8th, 15th, 22nd day and 1 month after completion of the treatment.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients who are having following symptoms
1. Recurrent sneezing
2. Watery rhinorrhoea
3. Nasal obstruction  
 
ExclusionCriteria 
Details  1. Known cases of chronic non specific infective rhinitis like hypertrophic rhinitis, atrophic rhinitis, rhinitis sicca, rhinitis caseosa, malignant granuloma.
2. Known cases of chronic specific infective rhinitis like syphilis, leprosy, T.B., lupus vulgaris, rhinosporidiosis, rhinoscleroma, fungal infections and leishmaniasis.
3. Patients with known case of systemic illnesses like hypertension, diabetes mellitus, HIV and HbSAg.
4. Patients with DNS, nasal polyps, tumors, malignancy of any kind.
5. Pregnant women.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare add on effects of Surasasidhha taila nasya 2 drops in each nostril at morning to Vyoshadi vati 250 mg 2 tablets twice daily after meal for 21 days in Allergic rhinitis patients of age group 18 years to 50 years.   21 days with follow up on 8th, 15th, 22nd day and 1 month after completion of the treatment.  
 
Secondary Outcome  
Outcome  TimePoints 
To observe the adverse effects of the drugs if any.  21 days with follow up on 8th, 15th, 22nd day and 1 month after completion of the treatment.  
 
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   N/A 
Date of First Enrollment (India)   08/04/2020 
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   None yey 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Allergic rhinitis is the common disease found in today’s population. In India, 20% to 30% of the population is suffering from allergic rhinitis. Changes in lifestyle, food habits and pollution contribute to the allergic conditions and lead them to chronic stages. Modern sciences treat allergic rhinitis with antihistamines and steroids given orally or nasally. But these drug have many side effects and the recurrence of disease is also noted. So there is need for the safe, effective and easily available quality drug. Allergic rhinitis is characterized by  paroxysmal sneezing, nasal obstruction, watery rhinorrhoea and nasal irritation. Vyoshadi vati has been previously studied and proven to be effective in pratishyay disease. As the symptoms of allergic rhinitis are similar to those of vataj pratishyay disease described in ayurveda, Vyoshadi vati can be given to treat allergic rhinitis. Surasa i.e. Ocimum sanctum has anti allergic properties according to modern studies and is also effective in pratishyay according to ayurveda. Hence Surasasidhha tailya nasya drops given through nasal route is taken for research study. The efficacy of Vyoshadi vati given with and without Surasasidhha taila nasya is to be studied and compared in this clinical trial.  
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