Bronchial AsthmaNCT02918487
Role of Herbs in the Management of Asthma
A study testing Polyherbal in people with Bronchial Asthma, run by Composite Interceptive Med Science at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Polyherbal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2016to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchial Asthma
- Being tested
- Polyherbal, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyherbalDrug
Also called Breathe Free
Each capsule contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum
PlaceboDrug
Inactive compound that is similar looking as the intervention
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | [Formoterol + Fluticasone] Single maintenance and reliever therapy(SMART) and Active polyherbal capsule Receives: Drug: Polyherbal; Drug: Placebo |
| Placebo | Placebo comparator | [Formoterol + Fluticasone] conventional along with inert similar looking placebo capsules Receives: Drug: Polyherbal; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline
Measured: 6 months
Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baseline
Measured: 6 months
Secondary outcomes (1)
Number of patients with frequency of asthma exacerbation per week
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startDec 2016
- Primary completion30 Apr 2018 (estimated)
- Study completion30 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Composite Interceptive Med Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Alben Sigamani, Principal investigator, Narayana Hrudayalaya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918487
- Sponsor's protocol ID
- OI - 004 - 2016
- Status last verified
- Apr 2018
- First submitted
- 27 Sep 2016
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Breathe Free® in the Management of Bronchial Asthma- A Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02918487
- Acronym / sponsor ID
- OI - 004 - 2016
- Conditions
- Bronchial Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Composite Interceptive Med ScienceIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Polyherbal, Drug: Placebo[Formoterol + Fluticasone] Single maintenance and reliever therapy(SMART) and Active polyherbal capsule |
| Placebo | Placebo comparator | Drug: Polyherbal, Drug: Placebo[Formoterol + Fluticasone] conventional along with inert similar looking placebo capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Any one of the following
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolyherbalAlso: Breathe FreeEach capsule contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum | Drug | Active, Placebo |
| PlaceboInactive compound that is similar looking as the intervention | Drug | Active, Placebo |
Primary outcome
Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline
Time frame: 6 months
Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baseline
Time frame: 6 months
1 secondary outcome
Number of patients with frequency of asthma exacerbation per week
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Alben Sigamani principal investigator
Narayana Hrudayalaya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyherbal in people with Bronchial Asthma, run by Composite Interceptive Med Science at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.