Bronchial Asthma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPlacebo
Inactive compound that is similar looking as the intervention
DRUGPolyherbal
Each capsule contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum
Sponsors
Composite Interceptive Med Science
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged ≥ 18 years. * History of asthma documented by a physician for at least 6 months * Patients on steroid therapy for at least 4 weeks. * If not on steroid therapy, patient and physician must be willing for 4 weeks run in on steroid therapy. * The subject agrees to participate in the study
Exclusion criteria
* Any one of the following * Acute illness (such as cold, flu, etc.) within one week before the administration of study drug * Abnormal hepatic and renal function * Pregnant, attempting to conceive, or lactating women * Current or former employees of organic India * Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days. * Physician uncomfortable with patient compliance to treatments or follow up. * Non-compliance to tobacco cessation therapy.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with frequency of asthma exacerbation per week | 6 months |
Countries
India
Outcome results
None listed