Health Condition 1: null- Bronchial Asthma
Conditions
Interventions
Intervention1: Ayuasmo Capsule: Ayuasmo Capsule contains Adhatoda vasica, Glycyrrhiza glabra, Alpinia galangal, Inula racemose, Phyllanthus emblica, Myrica Nagi, Sida cordifolia, Clerodendrum indicum,
Sponsors
Welex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 2.Patients with diagnosis of bronchial asthma, for a period of at least 6 months prior to screening visit. 3.Patients not on continue use of inhalers bronchodilators. 4.Percentage FEV1 more than 50% of prediction (predicted values) on screening visit. 5.Subjects willing to give informed consent and ready to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1.Known cases of severe/chronic diseases those interfere with study. 2.Known cases of active malignancy. 3.Subjects giving history of significant cardiovascular event less than 12 weeks prior to screening. 4.Known cases of chronic cardiac illnesses 5.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 6.Subjects with uncontrolled diabetes and hypertension. 7.Subjects using any other investigational drug within 1 month prior to recruitment in this study. 8.Known hypersensitivity to any of the ingredients used in study drug. 9.Pregnant and Lactating females. 10.Subjects currently participating in any other clinical study. 11.Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monthly assessment of FEV1 (the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometer testing)Timepoint: Day-7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of symptoms of Bronchial asthma 2.Changes in Asthma Control Questionnaire. 3.Changes in other pulmonary function Tests 4.Frequency of use of rescue medications 5.Global assessment for overall change by subject and investigator at the end of 90 days of study treatment. 6.Assessment of tolerability of AyuAsmo capsule by assessing Adverse Events 7.Assessment of Post treatment clinically significant changes occurred in laboratory parametersTimepoint: Day-7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | — |
Countries
India
Contacts
Public ContactVandana Bade
Target Institute of Medical Education and Research
Outcome results
None listed