| CTRI Number |
CTRI/2025/08/093075 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| 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
|
Comparing the efficacy of herbal nebulization versus Asthalin / Budecort nebulization in Jeerna Tamaka shwasa (chronic bronchial asthma )in Children 6 years to 18 years |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Herbal Nebulization versus Asthalin / Budecort
Nebulization in the prevention and management of Jeerna Tamaka shwasa (Chronic
Bronchial asthma) In Children: A Randomized Controlled Trial |
| 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 Angad Marotrao Gaikwad |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha |
| Address |
Room No 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8149715031 |
| Fax |
|
| Email |
angadgaikwad11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renu Rathi |
| Designation |
Professor and HOD |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha |
| Address |
Room No 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9011058302 |
| Fax |
|
| Email |
rbr.226@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Angad Marotrao Gaikwad |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha |
| Address |
Room No 41 Department of Kaumarbhritya Mahatma Gandhi
Ayurved College Hospital and Research Centre Salod(H) Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8149715031 |
| Fax |
|
| Email |
angadgaikwad11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod (H) Wardha Dist
Wardha Maharashtra India 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved college hospital and Research centre |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre
Salod(H) Wardha MAHARASHTRA 442001 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Angad Marotrao Gaikwad |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha. |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi
Ayurved College, Hospital and Research Centre Salod(H) Wardha.
MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA |
8149715031
angadgaikwad11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College, Hospital and Research Centre Institutional Committee, Salod(H) Wardha, Maharashtra 442001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Herbal Nebulization, Reference: Herbal Nebulization Reference: International Journal of Pharmaceutical Research and Applications Volume 9, Issue 2 Mar-Apr 2024, pp: 78-87 www.ijprajournal.com An overview of the use of herbal remedies in nebulizers for the treatment of cold, cough, and respiratory issues. Herbal Nebulization drugs 1)Shunthi ( Trishna nighrahan Charak sutrasthana 4/29 ) 2)Marich ( Deepan kapha vataghna Bhavprakash 60) 3) Pippali ( Kasahara Charak sutrasthana 4/36 ) 4)Bharangi (Kasa shwasagna Bhavprakash 183) 5)Tulsi (Kaphavatjeet Bhavprakash 63 ) 6)Vasa (Swasa,kasa,kshyapah Bhavprakash 90 7)Haridra (Lekhaniya Charak sutrastha 1/3) 8)Yashtimadhu (Medhya rasayan Charak sutrasthana 1/3) 9)Shunti(Swashara Charak sutrasthana4/37), Route: Nasal, Dosage Form: Swaras/ Juice, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: This study provides a comprehensive review of the utilization of herbal formulations in nebulization therapy aimed at managing common respiratory conditions such as cold, cough, and other related ailments. The approach emphasizes the therapeutic efficacy of various Ayurvedic herbs known for their respiratory benefits | | 2 | Comparator Arm (Non Ayurveda) | | - | Asthaline and Budecort respules for nebulization | 1 Asthalin (Salbutamol) Dose 0.1mg /kg Inhalation once a day 2 Budecort ( Budesonide) Dose 0.5mg – 1 mg Inhalation once a day for 4 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with mild to moderate asthma
Informed consent from parents or guardians
Children in Aavegavastha of Tamakswasa |
|
| ExclusionCriteria |
| Details |
Acute exacerbation of asthma requiring hospitalization
Known hypersensitivity to herbal preparation
Other chronic respiratory or systemic illness
Vegavastha of Tamakswasa |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from sign and symptoms of Breathlessness, Relief from cough, Relief from dyspneic attacks, Relief in night waking due to asthma |
weekly assessment on 7th, 14th and 28th day in the 4 week 28 day study duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from activity limitations due to asthma |
28 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/10/2025 |
| 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="2"
Months="0"
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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per a computer-generated table. The clinical research format will be prepared and validated. Before the study approval is taken from the IEC, MGACHRC, Salod Wardha, and CTRI registration will be done. After selection, each participant will be tested individually and selected according to the selection criteria. They are divided into two groups. The trial is a randomized controlled clinical trial. It will include 28 days of treatment with weekly assessment on the 7th,14th, and 28th day, and follow-up on the 30th day |