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Comparative study on Efficacy of Lavangathi Chooranam and Swasakudori Mathirai in the management of Soolikanam (Bronchial Asthma) in Children

A Phase II single centric randomized comparative open clinical trial on efficacy of Lavangathi chooranam and Swasa kudori Mathirai in the management of Soolikanam (Bronchial asthma) in Children - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084732
Enrollment
60
Registered
2025-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Intervention1: Lavangathi chooranam: Pediatric dose will be calculated using clark rule for each child. The adult dose is 6g The drug will be administered Twice a day Route of administration is oral

Sponsors

National Institute of Siddha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children having 3-4 major clinical symptoms of asthma such as cough, wheezing, tightness of chest, shortness of breath, nocturnal cough with breathlessness and abdominal bloating will be included. Children having FEV1 60% to 80%, with positive test of reversibility will be included in the study. The positive BD reversibility test (as per GINA guidelines) is defined as increase in FEV1 of more than 12% predicted 10-15 minutes after inhalation of 200 mcg of salbutamol. Children co-operate for performing spirometry test will be included.

Exclusion criteria

Exclusion criteria: Children with known case of Tuberculosis, Pneumonia, Bronchiectasis, cystic fibrosis, history of severe Bronchopulmonary dysplasia or underlying significant respiratory disease apart from asthma and with history of congenital heart disease will be excluded. Oxygen saturation less than 95% at screening visit or baseline visit. Frequent H/O hospitalization due to status Asthmaticus

Design outcomes

Primary

MeasureTime frame
The efficacy of the trial drugs Lavanagathi chooranam and Swasakudori mathirai will be compared using C- ACT ( Childhood Asthma Control Test).Timepoint: 18 months

Secondary

MeasureTime frame
The efficacy of Lavanagathi chooranam and Swasakudori mathirai will be measured by using C- ACT (Childhood Asthma Control Test) and Pulmonary Function Test - FEV1 (Forced Expiratory Volume in 1 second) and PEFR ( Peak Expiratory Flow Rate).Timepoint: 18 months;The efficacy of Swasakudori mathirai will be measured by using C- ACT (Childhood Asthma Control Test) and Pulmonary Function Test - FEV1 (Forced Expiratory Volume in 1 second) and PEFR ( Peak Expiratory Flow Rate).Timepoint: 18 months;The efficacy of the trial drugs Lavanagathi chooranam and Swasakudori mathirai will be compared using Pulmonary Function Test - FEV1 (Forced Expiratory Volume in 1 second) and PEFR ( Peak Expiratory Flow Rate).Timepoint: 18 months

Countries

India

Contacts

Public ContactDr M Meenakshi Sundaram

National Institute of Siddha

mmssiddha@rediffmail.com9444214581

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026