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CTRI Number  CTRI/2025/05/087352 [Registered on: 22/05/2025] Trial Registered Prospectively
Last Modified On: 22/05/2025
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 Study To Test If Dronapushpi Arka Nebulization Helps Treat Bronchial Asthma In Children. 
Scientific Title of Study   Randomized Controlled Clinical Study To Evaluate The Efficacy Of Dronapushpi Arka Nebulization In Tamakashwasa With Special Reference To Bronchial Asthma 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 Sahil Dilip Gawande 
Designation  Pg Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore 
Address  OPD no. 9 Department oF PG Studies In Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research Hospital 21st km Kanakapura road Udyapura PO OB Chudahalli Banglore KARNATAKA 560082 Inida

Bangalore
KARNATAKA
560082
India 
Phone  8857875561  
Fax    
Email  gawandesahil0298@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sahil Dilip Gawande 
Designation  Pg Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore 
Address  OPD no. 9 Department oF PG Studies In Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research Hospital 21st km Kanakapura road Udyapura PO OB Chudahalli Banglore KARNATAKA 560082 Inida

Bangalore
KARNATAKA
560082
India 
Phone  8857875561  
Fax    
Email  gawandesahil0298@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deshpande Sharavari Sunil 
Designation  Associate Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore 
Address  Department oF PG Studies In Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research Hospital 21st km Kanakapura road Udyapura PO OB Chudahalli Banglore KARNATAKA 560082 Inida

Bangalore
KARNATAKA
560082
India 
Phone  9901059707  
Fax    
Email  drsharvarideshpande@icloud.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road,Udayapura Post, Bangalore. Karnataka 560082 India 
 
Primary Sponsor  
Name  Dr Sahil Dilip Gawande 
Address  OPD no. 9 Department oF PG Studies In Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research Hospital 21st km Kanakapura road Udyapura PO OB Chudahalli Banglore KARNATAKA 560082 Inida 
Type of Sponsor  Other [SELF] 
 
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 Sahil Dilip Gawande  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore  OPD no. 9 Department oF PG Studies In Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research Hospital 21st km Kanakapura road Udyapura PO OB Chudahalli Banglore KARNATAKA 560082 Inida
Bangalore
KARNATAKA 
08857875561

gawandesahil0298@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITEE  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 ArmDrugClassical(1) Medicine Name: Dronapushpi, Reference: Bhava prakash, Route: Nasal, Dosage Form: Arka, Dose: 2.5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: Route- Oro-Nasal
2Comparator ArmDrugClassical(1) Medicine Name: Parnayavani , Reference: Bhava prakash , Route: Nasal, Dosage Form: Arka, Dose: 2.5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: Route- Oro-Nasal
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  1. Children Of Age Group 6-11 Years, Irrespective Of Gender, Religion And Socio Economic Status Will Be Included.
2. Children With Mild To Moderate Exacerbations Of Asthma Will Be Included.
3. Children Whose Parents Are Willing To Sign The Written Consent Form Will Be Included. 
 
ExclusionCriteria 
Details  1. Children With Severe Exacerbations Of Asthma Will Be Excluded.
2. Children With Known Case Of Tuberculosis, Emphysema, COPD Will Be Excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To clinically evaluate and compare the efficacy of Dronapushpi Arka and Parnayavani Arka nebulization in the management of Tamaka Shwasa (Bronchial Asthma) in children, based on the outcomes assessed through GINA (Global Initiative for Asthma) scoring.  0TH day,7TH day,9TH day 
 
Secondary Outcome  
Outcome  TimePoints 
1.To Do A Detailed Literary Review Of Tamaka Shwasa.
2.To Monitor The Adverse Drug Reaction.

 
1 year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   05/06/2025 
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="6"
Days="9" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Children are among the most vulnerable groups in society and need special care. Bronchial asthma is a common non-communicable disease that affects both children and adults. It is the most frequent chronic illness in children. Asthma is marked by episodes of breathing difficulty caused by airway inflammation and blockage, which is usually reversible.

Out of 200 million asthma patients worldwide, about 15 million are in India. In Indian children aged 5–11 years, the estimated asthma rate is 10% to 15%. Moderate to severe cases need daily treatment with long-term medicines (like anti-inflammatory drugs) to manage inflammation and prevent symptoms. Inhaled short-acting medicines are used to relieve sudden symptoms.

A major breakthrough in modern treatment is inhalation therapy, using drugs like Salbutamol and corticosteroids via nebulizers or aerosols. Inhaled medicine works fast because the lungs absorb it quickly, providing quick relief.

However, modern medicines often cause side effects and may not be ideal for long-term use. In Ayurveda, Bronchial Asthma is similar to "Tamaka Shwasa," a Vata-Kaphaja disorder with symptoms like labored breathing, cough, and wheezing. Herbal treatments (phyto-medicines) are becoming popular again due to their safety and effectiveness, as shown in clinical studies.

There is a need to develop Ayurvedic inhalation therapies that are safe, effective, and suitable for daily use. Herbs with properties like pungent (Katu), bitter (Tikta) taste, hot potency (Ushna Virya), and volatile nature are useful for nebulization. Dronapushpi and Parnayavani have these qualities. They help clear airways by reducing Kapha and supporting Vata balance.

Studies show these herbs contain volatile oils with strong bronchodilator effects. Using them as a distillate (Arka) in nebulization may benefit children with Tamaka Shwasa. This study focuses on evaluating the effectiveness of Dronapushpi Arka nebulization in such cases.

 
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