| CTRI Number |
CTRI/2025/09/095348 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| 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 Compare the Effect of Yashtimadhu-Antamula and Bharangi Mool Arka Nebulization in Managing Childhood Bronchial Asthma |
|
Scientific Title of Study
|
A Randomized Open Label Comparative
Clinical Study to evaluate the efficacy of Yashtimadhu-Antamula and Bharangi Mool Arka Nebulization in the management of Tamaka Shwasa (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 Prachi Thind |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Haryana
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
9518876988 |
| Fax |
|
| Email |
prachithind0067@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kataria |
| Designation |
Professor PG Dept. of Kaumarbhritya |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Haryana
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
9034001230 |
| Fax |
|
| Email |
dramitkataria@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Thind |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Haryana
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
9518876988 |
| Fax |
|
| Email |
prachithind0067@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Former Shri Krishna Government Ayurvedic College and Hospital Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118 India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Institute for Ayurved Studies and Research umri road sector 8 Kurukshetra 136118 |
| Type of Sponsor |
Government medical college |
|
|
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 Prachi Thind |
Institute for Ayurved Studies and Research |
PG Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Haryana
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA |
9518876988
prachithind0067@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna AYUSH University |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bharangi Mool Arka Nebulization, Reference: Bhava Prakasa Nighantu, Route: Nasal, Dosage Form: Arka, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -Bharangi Mool Arka Nebulization | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu-Antamula Nebulization, Reference: Bhav Prakasa Nighantu and Priya Nighantu, Route: Nasal, Dosage Form: Arka, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Yashtimadhu-Antamula Extract for Nebulization |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Parents of children willing to participate in the research trial.
2. Children of age group 6-18 years. irrespective of Caste, Sex, Religion and socioeconomic status.
3. The patient having classical sign and symptoms of Tamaka Shwasa. (Bronchial Asthma). |
|
| ExclusionCriteria |
| Details |
1. Any acute or severe illness during treatment.
2. Parents not willing to continue the treatment.
3. Any kind of anaphylactic reaction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the classical signs and symptoms of Tamaka Shwasa such as Shwasa Kashtata, Kasa, Ghurghur Shabda, Peenasa, Asino labhte
Saukhayam as well as in PEF and spirometry grading |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical safety and tolerability of Yashtimadhu-Antamula Nebulization in the management of
Tamaka Shwasa (Bronchial Asthma) will be assessed. |
7th and 14th Day |
|
|
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)
|
01/12/2025 |
| 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="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 present clinical study is designed to assess the comparative efficacy of Yashtimadhu–Antamula nebulization and Bharangi Moola Arka nebulization in children of age group 6–18 years of Tamaka Shwasa. A total of 40 patients will be selected from the OPD of the Department of Kaumarbhritya, Institute for Ayurved Studies and Research, SKAU, and randomly allocated into two groups of 20 each. Group A will receive Yashtimadhu–Antamula extract for nebulization and Group B will receive Bharangi Moola Arka nebulization, with 2 ml of the respective medicine administered twice daily for 7 days. The efficacy of treatment will be evaluated on the basis of improvement in classical symptoms of Tamaka Shwasa, along with spirometry and PEFR recordings before and after the intervention. |