Health Condition 1: J454- Moderate persistent asthma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18-59 years(both sex) suffering from mild and moderate-persistent bronchial asthma characterized by -Daily symptoms of asthma -Nocturnal awakenings more than once per week -Daily need for SABAs for symptom relief -More than just minor limitation in normal activity -FEV1 between 60 and 80 percent of predicted and an FEV/FVC ratio less than the lower confidence interval for normal
Exclusion criteria
Exclusion criteria: -Patients with fever, drug-induced asthma, aspirin intolerance triad, asthma with fixed airflow limitation, asthma with obesity, late-onset asthma will be excluded. -History of heart, liver, kidney, or other organ diseases; -Allergy or intolerance to the individual constituents in NONIZHI -Subjects who are pregnant and lactating mothers, or with any serious or invalidating other disease limiting full adhesion to the protocol. -Participation in an investigational drug trial in the 30 days prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of symptom scores & use of β-agonist, Pulmonary function tests and Absolute Eosinophil counts. The effect of treatment on symptom scores will be evaluated by analysing average daily symptom scores of treatment on the basis of 3 categories: daytime symptoms, nocturnal symptoms, and allergic nasal and ocular symptoms. Each category will be scored 0 to 3, with a maximum possible score of 9. Timepoint: week 4, 8 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of nutritional status using DETERMINE Your nutritional health checklist questionnaire and BMI and mid arm circumferenceTimepoint: week 4, 8 and 12 | — |
Countries
India
Contacts
KI3, CRO