Role of Herbs in the Management of Asthma

Study Overview
=================
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.

Official Title
-----------------
Role of Breathe Free® in the Management of Bronchial Asthma- A Randomized Placebo Controlled Trial

Conditions
-----------------
Bronchial Asthma

Intervention / Treatment
-----------------
* Drug: Polyherbal
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>[Formoterol + Fluticasone] Single maintenance and reliever therapy(SMART) and Active polyherbal capsule | Drug: Polyherbal<br>* Each capsule contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum<br>* Other names: Breathe Free;Drug: Placebo<br>* Inactive compound that is similar looking as the intervention<br>|
| Placebo Comparator: Placebo<br>[Formoterol + Fluticasone] conventional along with inert similar looking placebo capsules | Drug: Polyherbal<br>* Each capsule contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum<br>* Other names: Breathe Free;Drug: Placebo<br>* Inactive compound that is similar looking as the intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with frequency of asthma exacerbation per week |  | 6 months |