Role of Herbs in the Management of Asthma

NCT02918487 | Unknown DMC

• 1 other identifier: OI - 004 - 2016
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (2)

• Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline

  6 months

• Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baseline

  6 months

Secondary Outcomes (1)

• Number of patients with frequency of asthma exacerbation per week

  6 months

Study Arms (2)

Active

EXPERIMENTAL

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

Drug: Polyherbal; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Polyherbal; Drug: Placebo

Interventions

Polyherbal DRUG

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

Also known as: Breathe Free

Active; Placebo

Placebo DRUG

Inactive compound that is similar looking as the intervention

Active; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Composite Interceptive Med Science: lead

Study Sites (1)

Mazumdar Shaw Mutispeciality Hospital

Bangalore, Karnataka, India

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dr. Alben Sigamani

  Narayana Hrudayalaya Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: September 29, 2016
• Study Start: December 1, 2016
• Primary Completion: April 30, 2018
• Study Completion: May 30, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

IN (1)