Role of Herbs in the Management of Asthma

April 10, 2018 updated by: Composite Interceptive Med Science

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India
        • Mazumdar Shaw Mutispeciality Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline
Time Frame: 6 months
6 months
Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baseline
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with frequency of asthma exacerbation per week
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Composite Interceptive Med Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

April 30, 2018

Study Completion (ANTICIPATED)

May 30, 2018

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (ESTIMATE)

September 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OI - 004 - 2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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