Role of Herbs in the Management of Asthma

NCT ID: NCT02918487

Last Updated: 2018-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-05-30

Brief Summary

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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

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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.

Conditions

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Bronchial Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

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

Group Type EXPERIMENTAL

Polyherbal

Intervention Type DRUG

Each capsule contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum

Placebo

Intervention Type DRUG

Inactive compound that is similar looking as the intervention

Placebo

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

Group Type PLACEBO_COMPARATOR

Polyherbal

Intervention Type DRUG

Each capsule contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum

Placebo

Intervention Type DRUG

Inactive compound that is similar looking as the intervention

Interventions

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Polyherbal

Each capsule contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum

Intervention Type DRUG

Placebo

Inactive compound that is similar looking as the intervention

Intervention Type DRUG

Other Intervention Names

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Breathe Free

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Composite Interceptive Med Science

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Alben Sigamani

Role: PRINCIPAL_INVESTIGATOR

Narayana Hrudayalaya Hospital

Locations

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Mazumdar Shaw Mutispeciality Hospital

Bangalore, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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OI - 004 - 2016

Identifier Type: -

Identifier Source: org_study_id

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