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CTRI Number  CTRI/2026/01/100862 [Registered on: 12/01/2026] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study on the effect of Shirisha Bharangyadi Kashaya alone and along with Vasadi Arka nebulization in asthma 
Scientific Title of Study   Standardization and A comparitive clinical study of Shirisha Bharangyadi Kashaya with and without Vasadi Arka nebulization in tamaka Shwasa (Bronchial Asthma) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhavana K 
Designation  MD Scholar 
Affiliation  Banaras Hindu university 
Address  Department of Dravyaguna,IMS,BHU Varanasi Uttar pradesh-221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  8618931237  
Fax    
Email  bhavanashetty2308@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bhavana K 
Designation  MD Scholar 
Affiliation  Banaras Hindu university 
Address  Department of Dravyaguna,IMS,BHU Varanasi Uttar pradesh-221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  8618931237  
Fax    
Email  bhavanashetty2308@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Poonam Sharma 
Designation  Associate Professsor 
Affiliation  Banaras Hindu university 
Address  Department of Dravyaguna,IMS,BHU Varanasi Uttar pradesh-221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  9452790116  
Fax    
Email  poonamsharma@bhu.ac.in  
 
Source of Monetary or Material Support  
Department of Dravyaguna Faculty of ayurveda IMS BHU Varanasi Uttar Pradesh 221005 Varanasi Uttarpradesh India  
 
Primary Sponsor  
Name  Department of Dravyaguna Faculty of Ayurveda 
Address  Institute of Medical Sciences Banaras Hindu university Varanasi Uttar pradesh India 221005 
Type of Sponsor  Government 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 Bhavana K  Sir Sunderlal Hospital   OPD 11A Department of Dravyaguna and OPD 21 and 22 Department of Kayachikitsa Indian medicine wing Institute of Medical sciences BHU Varanasi Uttarpradesh
Varanasi
UTTAR PRADESH 		 8618931237

bhavanashetty2308@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instittutional Ethics Committee of Banaras Hindu university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Shirisha Bharangyadi Kashaya, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: Vasadi Arka , Reference: NA, Route: Nasal, Dosage Form: Arka, Dose: 2.5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: Along with vasadi arka nebulisation, Shirish bharangyadikashaya in the dose of 50 ml BD will be given to the participants
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient with stable bronchial asthma asper WHO GINA Guidelines for atleast 6 weeks prior to study entry
positive test of reversibility
FEV1 more than 50 and less than 80
FEV1 and FEV ratio less than 70 
 
ExclusionCriteria 
Details  Patients with PEFR less than 50 or FEV lessthan 50
patient having pulmonary diseases other than asthma like COPD,fibrotic lung disease,lung TB etc.
Pregnant and lactating women
Patient with poorly controlled diabetes
Patient with poorly controlled HTN(systolic greater than 160 and diastolic greater than 100
Patients on prolonged medications (greater than 6 weeks) that may have influence on the outcome of the study
Smoker or alcoholic or drug abuser
Patients who have past history of Atrial fibrillation,acute coronary syndrome,MI,stroke or severe arrythmia in last 6 months
Patient having systemic illness necessiating long term drug treatment like TB,carcinoma,endocrine disorders etc.
Patients who have completed participation in any otherclinical trial during past 6 months.
Patient having SPO2 less than 90
Emergency patients requiring O2 nebulization


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measure include improvement in asthma symptoms and pulmonary
function measured by Grading Analog Scale (GAS), Asthma control test(ACT) and
PFTs 		 90 days study with follow up every 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Health-related QOL will be our secondary outcome measure.  90 days study with follow up every 1 month 
 
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 2/ Phase 3 
Date of First Enrollment (India)   16/03/2026 
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="7"
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   64 patients of Bronchial Asthma will be included in this interventional study which will be randomly divided into 2 groups of 32 patients in each group.One group will be prescribed Shirisha Bharangyadi kashaya .Second group will be prescribed Shirisha Bharangyadi kashaya with Vasadi arka nebulization . The results will be analyzed statistically. 
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