Role of Herbs in the Management of Asthma

Bronchial Asthma Clinical Trial

Official title:

Role of Breathe Free® in the Management of Bronchial Asthma- A Randomized Placebo Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02918487
• Other study ID #: OI - 004 - 2016
• Status: Active, not recruiting
• Phase: N/A
• First received: September 27, 2016
• Last updated: April 10, 2018
• Start date: December 2016
• Est. completion date: May 30, 2018

Study information

• Verified date: April 2018
• Source: Organic India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: May 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
India	Mazumdar Shaw Mutispeciality Hospital	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Organic India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline		6 months
Primary	Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baseline		6 months
Secondary	Number of patients with frequency of asthma exacerbation per week		6 months