Study Results
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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UNKNOWN
NA
38 participants
INTERVENTIONAL
2016-12-31
2018-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Active
\[Formoterol + Fluticasone\] Single maintenance and reliever therapy(SMART) and Active polyherbal capsule
Polyherbal
Each capsule contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum
Placebo
Inactive compound that is similar looking as the intervention
Placebo
\[Formoterol + Fluticasone\] conventional along with inert similar looking placebo capsules
Polyherbal
Each capsule contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum
Placebo
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
Placebo
Inactive compound that is similar looking as the intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Composite Interceptive Med Science
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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OI - 004 - 2016
Identifier Type: -
Identifier Source: org_study_id
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