To study the effect of an Ayurvedic Polyherbal Formulations in children suffering from Bronchial Asthma.

The Efficacy Of Kharjuradi Avaleha In The Management Of Tamaka Shwasa (Bronchial Asthma) In Children - An Open Label Randomized Controlled Clinical Trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/05/042787

Enrollment

Registered

2022-05-24

Start date

Unknown

Completion date

Unknown

Last updated

2022-05-30

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

Conditions

Health Condition 1: J45- Asthma

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either gender suffering from Tamaka Shwasa (having more than one of these features Shwasakashtata (Breathelessness), Kasa (Cough),Ghurghuram (Wheezing) and Parshvashoola (Chest tightness)between age group of 5 to 16 years will be included in the study. Patients with history of at least three episodes of Asthma symptoms during previous year. Patients who are willing and will give their consent to participate in study.

Exclusion criteria

Exclusion criteria: Patients below 5 years and above 16 years of age. Patients suffering from other chronic lung diseases (other than asthma) such as cystic fibrosis, COPD or bronchiectasis, Patients with severe bronchial asthma with prolonged remissions (lasting more than a month). Patients with clinically significant cardiovascular disorders, other infectious diseases, with clinically significant cardiovascular, renal, liver, neurological, hematological, endocrinal, infectious, disorders or chronic respiratory disease other than asthma. 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 decrease in frequency, duration and severity of attacks.Timepoint: 0 day, 15 day, 30 day, 45 day, 60 day	—

Secondary

Measure	Time frame
1. Paediatric Asthma Quality Of Life Questionnaire (PAQLQ) 2. Asthma Control Questionnaire (ACQ) 3. GINA assessment of asthma control in adults, adolescents and children 6 â?? 11 years and Pediatric Asthma Symptom Scale from RAND Health Care. 4. Pulmonary Function Test BySpirometery FEV (Forced expiratory volume), FVC (Forced vital capacity), (Peak expiratory flow rate) 5. Hb% (Hemoglobin), TLC(Total leucocytes count) DLC (Differential leucocytes count), ESR (Erythrocyte Sedimentation Rate), TEC (Total Eosinophil Count)or Sr IgE (if possible). 6. Nutritional status of the subjects.Timepoint: 0 day, 30 day, 60 day	—

Measure

Time frame

1. Paediatric Asthma Quality Of Life Questionnaire (PAQLQ) 2. Asthma Control Questionnaire (ACQ) 3. GINA assessment of asthma control in adults, adolescents and children 6 â?? 11 years and Pediatric Asthma Symptom Scale from RAND Health Care. 4. Pulmonary Function Test BySpirometery FEV (Forced expiratory volume), FVC (Forced vital capacity), (Peak expiratory flow rate) 5. Hb% (Hemoglobin), TLC(Total leucocytes count) DLC (Differential leucocytes count), ESR (Erythrocyte Sedimentation Rate), TEC (Total Eosinophil Count)or Sr IgE (if possible). 6. Nutritional status of the subjects.Timepoint: 0 day, 30 day, 60 day

—

Countries

India

Contacts

Public ContactDr Rajagopala S

All India Institute of Ayurveda

srajagopala@gmail.com7600902564

Outcome results