Back to resultsRole of Herbs in the Management of Asthma
Primary Purpose
Bronchial Asthma
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Polyherbal
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bronchial Asthma
Eligibility Criteria
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.
Sites / Locations
- Mazumdar Shaw Mutispeciality Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
[Formoterol + Fluticasone] Single maintenance and reliever therapy(SMART) and Active polyherbal capsule
[Formoterol + Fluticasone] conventional along with inert similar looking placebo capsules
Outcomes
Primary Outcome Measures
Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline
Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baseline
Secondary Outcome Measures
Number of patients with frequency of asthma exacerbation per week
Full Information
NCT ID
NCT02918487
First Posted
September 27, 2016
Last Updated
April 10, 2018
Sponsor
Composite Interceptive Med Science
1. Study Identification
Unique Protocol Identification Number
NCT02918487
Brief Title
Role of Herbs in the Management of Asthma
Official Title
Role of Breathe Free® in the Management of Bronchial Asthma- A Randomized Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
May 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Composite Interceptive Med Science
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
[Formoterol + Fluticasone] Single maintenance and reliever therapy(SMART) and Active polyherbal capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
[Formoterol + Fluticasone] conventional along with inert similar looking placebo capsules
Intervention Type
Drug
Intervention Name(s)
Polyherbal
Other Intervention Name(s)
Breathe Free
Intervention Description
Each capsule contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inactive compound that is similar looking as the intervention
Primary Outcome Measure Information:
Title
Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline
Time Frame
6 months
Title
Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of patients with frequency of asthma exacerbation per week
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Alben Sigamani
Organizational Affiliation
Narayana Hrudayalaya Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mazumdar Shaw Mutispeciality Hospital
City
Bangalore
State/Province
Karnataka
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Role of Herbs in the Management of Asthma
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