Role of Herbs in the Management of Asthma

Composite Interceptive Med Science

Status: Unknown

Conditions: Bronchial Asthma

Treatments: Drug: Placebo; Drug: Polyherbal

Study type: Interventional

Funder types: Industry

Identifiers

NCT02918487

OI - 004 - 2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

\[Formoterol + Fluticasone\] Single maintenance and reliever therapy(SMART) and Active polyherbal capsule

Treatment:

Drug: Polyherbal

Drug: Placebo

Placebo

Placebo Comparator group

Description:

\[Formoterol + Fluticasone\] conventional along with inert similar looking placebo capsules

Treatment:

Drug: Polyherbal

Drug: Placebo