| CTRI Number |
CTRI/2025/09/095156 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to find out how well an Ayurvedic medicine (Vyaghriharitaki Avaleha), with or without another medicine (Oriladi Kashaya Ghana Vati), helps in treating asthma (Tamaka Shwasa) in children aged 6 to 12 years |
|
Scientific Title of Study
|
Efficacy of vyaghriharitaki avaleha with and without oriladi kashaya ghana vati in the management of tamaka shwasa (bronchial asthma) in children age 6 to 12 years a randomized controlled clinical study |
| 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 Swati Nair |
| Designation |
PG Scholar |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Room No. 406, Department of Kaumarbhritya, Academic Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi – 110076, South Delhi, India.
New Delhi
DELHI
110076
India |
| Phone |
7306009262 |
| Fax |
|
| Email |
swatinair07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajagopala S |
| Designation |
Head of Department |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Room No. 404, Department of Kaumarbhritya, Academic Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi – 110076, South Delhi, India.
New Delhi
DELHI
110076
India |
| Phone |
7600902564 |
| Fax |
|
| Email |
srajagopala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Nair |
| Designation |
PG Scholar |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Room No. 406, Department of Kaumarbhritya, Academic Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi – 110076, South Delhi, India.
New Delhi
DELHI
110076
India |
| Phone |
7306009262 |
| Fax |
|
| Email |
swatinair07@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
110076
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
110076
|
| 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 Swati Nair |
All India Institute of Ayurveda |
Room no 406 Department of Kaumarbhritya Academic block All India
Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076
New Delhi
DELHI |
7306009262
swatinair07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIA ,Division of Translational Research & Biostatistics,INSTITUTIONAL ETHICS COMMITTEE |
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: Oriladi Kashaya Ghana Vati, Reference: Sahasrayoga Kashaya Prakarna, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vyagrihareetaki Avaleha, Reference: Bhaishajya Ratnavali Kasarogadhikara Prakarna, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children between 6–12 years of age irrespective of gender
2.Patients with mild to moderate bronchial asthma with at least three asthma episodes during last one year.
3.Diagnosis of asthma based on the criteria of the Global Initiative for Asthma (GINA).
4.Provided a signed statement of informed LAR consent/assent from both the parent/guardian and child/adolescent.
5.Patients with Tamaka Shwasa categorized under Sukha Sadhya and Krichra Sadhya as per Ayurvedic assessment will be included.
6.Patients on other drug therapy will be included only after completion of the wash out period prescribed.
|
|
| ExclusionCriteria |
| Details |
1.Patients below 6 years and above 12 years of age.
2.Patients with severe bronchial asthma with prolonged remissions (lasting more than a month).
3.Severe and Complicated respiratory allergic disorders those need hospitalization.
4.Diagnosed C/o Tuberculosis, Pleural effusion, Emphysema, Lung abscess, Bronchiectasis, Pleurisy, Nasal polyps, Congenital lung/cardiac anomalies, Chronic debilitating diseases
5.Individuals with significant cardiovascular conditions, additional infectious ailments, and clinically significant disorders affecting the cardiovascular, renal, hepatic, neurological, haematological, endocrine, or respiratory systems, are excluded.
6.Patients who are not willing to comply with the protocol requirements will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in classical sign and symptoms of Tamaka Shwasa in terms of reduction in frequency, duration and severity of attacks.
|
0th day, 15th day, 30th day, 45th day, 60th day, 75th day, 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in Paediatric Asthma Quality of Life Questionnaire (PAQLQ).
2.Reduction in FeNO level.
3.Improvement in Pulmonary Function Test by FOT (Forced Oscillation technique).
4.To assess any probable side effects such as gastrointestinal discomfort or pain, altered taste, dryness of mouth, allergic reactions, or any other side effects observed during and after the intervention period.
|
0th day, 15th day, 30th day, 45th day, 60th day, 75th day, 90th day |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2025 |
| 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="0"
Months="3"
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
|
TITLE OF THE STUDY
Efficacy of Vyaghriharitaki Avaleha with and without Oriladi Kashaya Ghana Vati in the management of Tamaka Shwasa bronchial asthma in children age 6 to 12 years a randomized controlled clinical study
RESEARCH QUESTION
Does the add on administration of Oriladi Kashaya Ghana Vati along with Vyaghriharitaki Avaleha reduce the cardinal symptoms of Tamaka Shwasa Bronchial Asthma compared to oral administration of Vyaghriharitaki Avaleha alone in children aged 6 to 12 years over 45 days HYPOTHESIS
Administering Oriladi Kashaya Ghana Vati in combination with Vyaghriharitaki Avaleha orally twice daily after food dosed as per the patients age along with lukewarm water as Anupana for a period of 45 days to children aged 6 to 12 years diagnosed with Tamaka Shwasa Bronchial Asthma is expected to effectively reduce asthma symptoms decrease their frequency duration and severity enhance pulmonary functions and ultimately enhance the quality of life in affected children compared to the oral administration of Vyaghriharitaki Avaleha alone NULL HYPOTHESIS H0
Administering Oriladi Kashaya Ghana Vati in combination with Vyaghriharitaki Avaleha orally twice daily after food dosed as per the patients age along with lukewarm water as Anupana for a period of 45 days to children aged 6 to 12 years diagnosed with Tamaka Shwasa Bronchial Asthma has no significant reduction in asthma symptoms decrease their frequency duration and severity enhance pulmonary functions and ultimately enhance the quality of life in affected children compared to the oral administration of Vyaghriharitaki Avaleha alone ALTERNATE HYPOTHESIS H1
Administering Oriladi Kashaya Ghana Vati in combination with Vyaghriharitaki Avaleha orally twice daily after food dosed as per the patients age along with lukewarm water as Anupana for a period of 45 days to children aged 6 to 12 years diagnosed with Tamaka Shwasa Bronchial Asthma results in a significant reduction in asthma symptoms decrease their frequency duration and severity enhance pulmonary functions and ultimately enhance the quality of life in affected children compared to the oral administration of Vyaghriharitaki Avaleha alone NEED OF THE STUDY For healthcare providers the challenges of managing asthma differ between regions and health systems Despite lot of efforts to improve asthma care over the past 30 years and the availability of effective medications many patients globally have not benefited from advances in asthma treatment and often lack even the rudiments of care Many of the worlds population live in areas with inadequate medical facilities and financial resources GINA recognizes that the recommendations found in this report must be adapted to fit local practices and the availability of healthcare resources To improve asthma care and patient outcomes evidence based recommendations must also be disseminated and implemented nationally and locally and integrated into health systems and clinical practice Implementation requires an evidence based strategy involving professional groups and stakeholders and considering local cultural and socioeconomic conditions This research aims to determine how well and how useful Oriladi Kashaya ghana vati along with Vyaghriharitaki Avaleha for treating Tamaka Shwasa in children Focusing on affordability and easy access the study seeks a practical way to manage childhood asthma and hopes to offer a safe and effective treatment that can be readily used in current healthcare
Considering the ongoing need for affordable and safe long term treatments for Tamaka Shwasa bronchial asthma even with the many formulations offered in Ayurveda the hence in this study a clinical trial is intended to evaluate the add on effect of Oriladi Kashaya ghana vati when administered along with Vyaghriharitaki Avaleha AIM AND OBJECTIVE OF RESEARCH STUDY
The aim of the present study is to assess the efficacy of interventions on the signs and symptoms of the disease Tamaka Shwasa vis a vis Bronchial Asthma and pulmonary function tests and quality of life parameters OBJECTIVES OF THE RESEARCH PROJECT PRIMARY OBJECTIVES
To assess the efficacy of Oriladi Kashaya Ghana Vati as an add on to Vyaghriharitaki Avaleha in reducing cardinal signs and symptoms in terms of frequency severity and duration of Tamaka Shwasa in participants of the study SECONDARY OBJECTIVES
To assess improvement in the quality of life of the patients of Tamaka Shwasa by using the Paediatric Asthma Quality of Life Questionnaire PAQLQ
To assess the reduction in FeNO level Pulmonary inflammation
To assess improvement in Pulmonary Function Test by FOT Forced oscillation technique
To assess and report any adverse drug reactions observed during and after the treatment period OUTCOME MEASURES PRIMARY OUTCOME
1 Improvement in classical signs and symptoms of Tamaka Shwasa in terms of reduction in frequency duration and severity of attacks SECONDARY OUTCOME
1 Improvement in Paediatric Asthma Quality of Life Questionnaire PAQLQ
2 Reduction in FeNO level
3 Improvement in Pulmonary Function Test by FOT Forced Oscillation Technique
4 To assess any probable side effects such as gastrointestinal discomfort or pain altered taste dryness of mouth allergic reactions or any other side effects observed during and after the intervention period PRIMARY ENDPOINT
Change in total cardinal symptom score including frequency severity and duration of Tamaka Shwasa symptoms from baseline to the end of treatment period SECONDARY ENDPOINT
Change in total PAQLQ score from baseline to end of treatment period
Change in fractional exhaled nitric oxide FeNO level measured in ppb from baseline to end of treatment
Change in pulmonary function parameters measured by FOT from baseline to end of treatment |