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The aim of this trial is to study the effect of a polyherbal capsule containing four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum in the treatment of bronchial asthma.
A randomized placebo controlled double blind trial. Four herbs that have proven efficacy on bronchial asthma will be given. Equally matched placebo will be given randomly to patients. Each arm active herbs and placebo will be compared against the Formoterol+Fluticasone Single maintenance and reliever therapy(SMART) and conventional therapy. All the parameters of Bronchial Asthma(BA) will be compared between the randomized groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | [Formoterol + Fluticasone] Single maintenance and reliever therapy(SMART) and Active polyherbal capsule |
|
| Placebo | Placebo Comparator | [Formoterol + Fluticasone] conventional along with inert similar looking placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyherbal | Drug | Each capsule contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline | 6 months | |
| Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baseline | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with frequency of asthma exacerbation per week | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Any one of the following
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Alben Sigamani | Narayana Hrudayalaya Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mazumdar Shaw Mutispeciality Hospital | Bangalore | Karnataka | India |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Placebo | Drug | Inactive compound that is similar looking as the intervention |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |