Role of Herbs in the Management of Asthma

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

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.

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.