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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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 | 2 | Comparator Arm | Drug | Classical | | (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. |