Comparing Two Ayurvedic Treatments for Childhood Asthma: A Study on Vasaharitakyadi Avaleha vs. Shwasahar Mahakashaya Avaleha

The Efficacy Of Vasaharitakyadi Avaleha In Comparasion To Shwasahar Mahakashaya Avaleha In The Management Of Tamaka Shwasa (Bronchial Asthma) In Children: An Open Label Randomized Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/074598

Enrollment

Registered

2024-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Eligibility

Inclusion criteria

Inclusion criteria: Including patients with intermittent, mild persistent, moderate persistent cases as per GINA classification 2023. Patients with mild to moderate bronchial asthma with at least three asthma symptoms during previous year. Diagnosis of asthma based on the criteria of the Global Initiative for Asthma (GINA). Provided a signed statement of informed LAR consent/assent from both the parent/guardian and child/adolescent.

Exclusion criteria

Exclusion criteria: Patients below 6 years and above 12 years of age. Patients with severe bronchial asthma with prolonged remissions (lasting more than a month). Severe and Complicated respiratory allergic disorders those need hospitalization. Diagnosed C/o Tuberculosis, Pleural effusion, Emphysema, Lung abscess, Bronchiectasis, Pleurisy, Nasal polyps, Congenital lung/cardiac anomalies, Chronic debilitating diseases Individuals with significant cardiovascular conditions, additional infectious ailments, and clinically significant disorders affecting the cardiovascular, renal, hepatic, neurological, haematological, endocrine, or respiratory systems, excluding asthma, are included. Patients who will not be willing to comply with protocol requirements will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
Improvement in classical sign and symptoms of Tamaka Shwasa in terms of reduction in frequency, duration and severity of attacks. time frame- day 0 day 15 day 30 day 45 day 60 day 75 day 90 i.e. day 0, day 45, day 90Timepoint: Improvement in classical sign and symptoms of Tamaka Shwasa in terms of reduction in frequency, duration and severity of attacks. time frame- day 0 day 15 day 30 day 45 day 60 day 75 day 90	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
Improvement in Pulmonary Function Test by Spirometry FEV (Forced expiratory volume), FVC (Forced vital capacity) PEFR (Peak expiratory flow rate) Improvement in Paediatric Asthma Quality of Life Questionnaire (PAQLQ) (As per annexure 2) Changes in laboratory parameters [Complete hemogram (DLC TLC Hb ESR) & Absolute Eosinophil count (AEC) & Serum IgE] Reduction in FeNO level (Pulmonary inflammation) (If feasible) time frame day 0 day 15 day 30 day 45 day 60 day 75 day 90Timepoint: Improvement in Pulmonary Function Test by Spirometry FEV (Forced expiratory volume) FVC (Forced vital capacity) PEFR (Peak expiratory flow rate) Improvement in Paediatric Asthma Quality of Life Questionnaire (PAQLQ) (As per annexure 2) Changes in laboratory parameters [Complete hemogram (DLC TLC Hb% ESR) & Absolute Eosinophil count (AEC) & Serum IgE] Reduction in FeNO level (Pulmonary inflammation) (If feasible) time frame day 0 day 15 day 30 day 45 day 60 day 75 day 90	—

Measure

Time frame

Improvement in Pulmonary Function Test by Spirometry FEV (Forced expiratory volume), FVC (Forced vital capacity) PEFR (Peak expiratory flow rate) Improvement in Paediatric Asthma Quality of Life Questionnaire (PAQLQ) (As per annexure 2) Changes in laboratory parameters [Complete hemogram (DLC TLC Hb ESR) & Absolute Eosinophil count (AEC) & Serum IgE] Reduction in FeNO level (Pulmonary inflammation) (If feasible) time frame day 0 day 15 day 30 day 45 day 60 day 75 day 90Timepoint: Improvement in Pulmonary Function Test by Spirometry FEV (Forced expiratory volume) FVC (Forced vital capacity) PEFR (Peak expiratory flow rate) Improvement in Paediatric Asthma Quality of Life Questionnaire (PAQLQ) (As per annexure 2) Changes in laboratory parameters [Complete hemogram (DLC TLC Hb% ESR) & Absolute Eosinophil count (AEC) & Serum IgE] Reduction in FeNO level (Pulmonary inflammation) (If feasible) time frame day 0 day 15 day 30 day 45 day 60 day 75 day 90

—

Countries

India

Contacts

Public ContactDr Rajagopala S

All India India Institute Of Ayurveda

srajagopala@gmail.com7600902564

Outcome results