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CTRI Number  CTRI/2025/02/079912 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 16/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   A Comparative Clinical Study Of Vasa Arka Nebulization And Kantakari Arka Nebulization In the Management Of Kaphaj Kasa In Children  
Scientific Title of Study   A Comparative Clinical Study To Evaluate The Efficacy Of Vasa Arka Nebulization And Kantakari Arka Nebulization In the Management Of Kaphaj Kasa In Children  
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 Dikshit Swarnkar 
Designation  PG Scholar 
Affiliation  Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) 
Address  Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur(C.G.) Raipur CHHATTISGARH 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9039201330  
Fax    
Email  dikshitswarnkar123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lowkesh Chandravanshi 
Designation  Associate Professor 
Affiliation  Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) 
Address  Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur(C.G.) Raipur CHHATTISGARH 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9827822231  
Fax    
Email  lowkeshc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neeraj Agrawal 
Designation  Professor & HOD 
Affiliation  Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) 
Address  Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur(C.G.) Raipur CHHATTISGARH 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9109923485  
Fax    
Email  dr_neeraj2001in@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) 492010 Raipur CHHATTISHGARH 
 
Primary Sponsor  
Name  Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur CG 
Address  Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G) 492010 Raipur CHHATTISGARH 
Type of Sponsor  Other [Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G) 492010 Raipur CHHATTISGARH] 
 
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 Dikshit Swarnkar  Shri Khudadad Doongaji Government Hospital Raipur Chhattisgarh   Department of Kaumarabhritya OPD No 07 and IPD Patient Shri Khudadad Doongaji Government Ayurveda Hospital Raipur Chhattisgarh 492010 Raipur CHHATTISGARH
Raipur
CHHATTISGARH 		 9039201330

dikshitswarnkar123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee Govt. Ayurveda College Raipur Chhattisgarh 492010  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: KAPAJAKASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Arka Prakash, Procedure details: 1. Vasa Arka Nebulization (Nasal Inhalation) (3 times/ day for 2-5 min) 1. 3-7 yr- 1.5 ml 2. 8-10 yr- 2 ml 3. 11-12 yr- 3 ml Duration of Intervention- 10 days)
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Arka Prakash, Procedure details: 1. Kantakari Arka Nebulization (Nasal Inhalation) (3 times/day for 2-5 min) 1. 3-7 yr- 1.5 ml 2. 8-10 yr- 2 ml 3. 11-12 yr- 3 ml (Duration of Intervention- 10 days))
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Patients Of Either Gender From Age 3-12 years.
2.Patients Have Classical symptoms of Kaphaj Kasa.
3.Patients complaint of bodyache along with mild to moderate symptoms of cough, wheezing, shortness of breathing, sore throat etc.
4.Subject willing to participate in study after consent. 
 
ExclusionCriteria 
Details  1. Chronic disorder like Tuberculosis, Pneumonia, RDS, CHD, COPD(Chronic obstructive pulmonary disease), pleural effusion, will be excludate form study.
2.Children with any congenital deformity.
3.Patient on long term medication as any steroids medicine.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Reduce Symptoms Of Kasa vega
(Frequency of Cough)
2.Nisthavati Ghanam Kapham (Productive Cough) Reduce 		 At Baseline, 10 Days of Active intervention, during Treatment follow up after 10th day and 10th day after post follow up in one month 
 
Secondary Outcome  
Outcome  TimePoints 
1.Reduce obstruction of upper respiratory tract.   10 Days of Active intervention, during Treatment follow up after 10 day and 10th day after post follow up in one month. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   07/04/2025 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 NIL  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Physiologically Kapha dosha is predominant in balya-awastha , may cause various kaphaj vyadhi such as kaphaj kasa. This is one of the most common disease that affect Pranvaha shrotas and further health of the child. Acute respiratory tract infection associated with the upper respiratory pathologies,. Intake of Arka and its benifits in tackling the signs and symptoms of cough, As these situation the inhalation routes developed so far is the better method to reduce the undesirable effects of systemic administration. In Arka Prakash author has explained Vasa Arka in the form of Nebulization also have anti asthmatic effect in human.
                                                                                                                                                                                                                 Present study aimed to re-evaluate the effect of Vasa Arka Nebulization on Kaphaj kasa. In the study subject will be advised for Nasal Inhalation of Vasa Arka Nebulization and dose of administration will be calculated based on child age group. Vasa Arka Nebulization will be advised in form of Nebulization for 10 days and follow up done in every 10th days for 1 month.
                                                                                                                                                                                                                 Assessment will be done on the basis of subjective and objective criteria adopted for the study. 
 
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