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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

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095156
Enrollment
74
Registered
2025-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J454- Moderate persistent asthma

Interventions

None listed

Sponsors

All India Institute of Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1.Improvement in classical sign and symptoms of Tamaka Shwasa in terms of reduction in frequency, duration and severity of attacks. Timepoint: 0th day, 15th day, 30th day, 45th day, 60th day, 75th day, 90th day

Secondary

MeasureTime frame
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. Timepoint: 0th day, 15th day, 30th day, 45th day, 60th day, 75th day, 90th day

Countries

India

Contacts

Public ContactDr Swati Nair

ALL INDIA INSTITUTE OF AYURVEDA

srajagopala@gmail.com7600902564

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026