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CTRI Number  CTRI/2024/02/062317 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 30/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Trayushanadi syrup and Bharangi Syrup in the management of Pratishyaya in children age group 3 to 6 years.  
Scientific Title of Study   A randomized controlled clinical study to evaluate efficacy of Tryushanadi Syrup and Bharangi Syrup in the management of Pratishyaya in the children age group 3 to 6 years.  
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 Aditi Anant Kulkarni 
Designation  PG Scholar 
Affiliation  PDEAS College of Ayurved And Research Centre Nigdi Pune 
Address  PDEAS College of Ayurved and Research Centre Balrog department third floor Nigdi Pune MAHARASHTRA 411044 INDIA Pune

Pune
MAHARASHTRA
411044
India 
Phone  8625884081  
Fax    
Email  kaditi490@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhavi Deodas 
Designation  Head Of Department 
Affiliation  PDEAS College of Ayurved And Research Nigdi , Pune 
Address  PDEAS College of Ayurved and Research Centre Balrog department third floor Nigdi Pune MAHARASHTRA 411044 INDIA Pune

Pune
MAHARASHTRA
411044
India 
Phone  9423010818  
Fax    
Email  drdeodasms@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Madhavi Deodas 
Designation  Head Of Department 
Affiliation  PDEAS College of Ayurved And Research Nigdi , Pune 
Address  PDEAS College of Ayurved and Research Centre Balrog department third floor Nigdi Pune MAHARASHTRA 411044 INDIA Pune

Pune
MAHARASHTRA
411044
India 
Phone  9423010818  
Fax    
Email  drdeodasms@gmail.com  
 
Source of Monetary or Material Support  
Information will be collected from the Pune District Education Association (PDEA) College Of Ayurved And Research Center Nigdi , Pune .  
 
Primary Sponsor  
Name  PDEAS College of Ayurved And Research Centre Nigdi Pune  
Address  PDEAS College of Ayurved And Research Centre ,Balrog Dapartment, third floor,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 Aditi Anant Kulkarni  Ayurved Rugnalay and Sterling multispeciality hospital nigdi pradhikaran pune  Ayurved Rugnalay And Sterling Multispeciality Hosptal Nigdi Pradhikaran Pune sector 27 Balrog Department OPD NO 118 Pune Maharashtra
Pune
MAHARASHTRA 		 8625884081

kaditi490@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PZETS College of Ayurved and Research Centre Akurdi, Pune Institutional Ethical Commity  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J00||Acute nasopharyngitis [common cold]. Ayurveda Condition: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Bharangi , Reference: Mishra B. Bhavprakash Nighantu. 11th ed. Vol. 1. Chaukhamba Sanskrit Bhavan; 2007. 101 p., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 1(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: 1ml/kg/day Three times day
2Intervention ArmDrugClassical(1) Medicine Name: Trayushanadi Syrup , Reference: Tripathi H. Vangsen Samhita. Chaukhamba Publication; 2007. 448 p., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 1(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: 1ml/kg/day Three times a day
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  History of symptoms of Pratishyaya in the children age group 3 to 6 years irrespective of sex ,socioeconomic status .patients suffering from Pratishyaya having sign and symptoms mentioned in Ayurved Samhita as Nasastrava,Kshavathu,Ghranoparodha,Kandu,Aruchi 
 
ExclusionCriteria 
Details  1-Congenital anamolies related to respiratory system
2-Known case of Asthma and Chronic infectious
disease- TB
3-Raktaj,Sannipataj ,Dushta Pratishyaya
4-High grade fever 
 
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 
1.To study the efficacy of Tryushanadi Syrup and Bharangi Syrup in the management of Pratishyaya in the children age group 3 to 6 years
2. To reduce the Pratishyaya 		 7 days study where Follow up on 3rd,5th,7 th day  
 
Secondary Outcome  
Outcome  TimePoints 
To study the adverse effect if any   7 days study where Follow up on 3rd,5th,7 th day  
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 1/ Phase 2 
Date of First Enrollment (India)   25/02/2024 
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="6"
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  


Pratishyaya is a very common disease seen all over the world causing much distress and discomfort to the children. It affects all humans irrespective of age, gender. Everybody suffers from this disease at least once in his lifetime. Pratishyaya hampers child’s ability to do daily activity and if it is not cured in acute stage then it may lead to complications  Kasa, Shwasa, Badhirya. Since last three decades the cases of pratishyaya  is increasing      because of the
 environmental changes like pollution, dust, smoke and wrong dietary habits. The rate of prevalence is up to 40%.
प्रतिश्याय निरुक्ती :

   à¤µà¤¾à¤¤ प्रति अभिमुखम श्यायो गमनं कफादीनां यत्र स प्रतिश्याय :॥

                                              मधुकोष माधव् निदान्-पान २५६
The vyadhi in which kaphaadi doshas are expelled out through nasika is known as pratihshyaya. It is characterised by Nasastrava, Nasanaha, Kshavathu, Ghranoparadha, Shirashool, Jwara, Kandu, Kasa, Swarabheda, Aruchi. 
       Management of pratishyaya in children needs more care and observation since the complications can make the condition worst in the advance stage of the disease. So the research should fast acting, effective and safe medicines with easy administration required in pediatric practice. Properties of Tryushanadi Syrup are Deepaniya, Pachaniya, Shothahara, Kasahara, Shwashara and Pinasahara.
 Properties of Bharangi Syrup are Kaphaghna, Ushna, Deepaniya, Pachaniya,
Shothahara, Kasahara, Shwashara and Pinasahara . Considering the palatability here the preparation in the syrup form so it is selected to find out the    efficacy 
 of Tryushanadi Syrup in the management of pratishyaya in children age group
 (3 to 6 yrs).
According to Vangsen samhita Tryushanadi Churna is used in Pratishyaya.Syrup is the modification of Churna .So Tryushanadi Syrup can be used in Pratishyaya. Tryushanadi Syrup is easy to administrate as compared to churna kalpana.
 
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