Role of Herbs in the Management of Asthma

Not Applicable

• Conditions: Bronchial Asthma
• Interventions: Drug: Polyherbal; Drug: Placebo

• Registration Number: NCT02918487
• Lead Sponsor: Composite Interceptive Med Science

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.

Study Timeline

• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-29
• Study Start: 2016-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11
• Primary Completion: 2018-04-30
• Study Completion: 2018-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	\[Formoterol + Fluticasone\] conventional along with inert similar looking placebo capsules
Active	Polyherbal	\[Formoterol + Fluticasone\] Single maintenance and reliever therapy(SMART) and Active polyherbal capsule
Active	Placebo	\[Formoterol + Fluticasone\] Single maintenance and reliever therapy(SMART) and Active polyherbal capsule
Placebo	Polyherbal	\[Formoterol + Fluticasone\] conventional along with inert similar looking placebo capsules

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of patients with frequency of asthma exacerbation per week	6 months

Trial Locations

Locations (1)

Mazumdar Shaw Mutispeciality Hospital; 🇮🇳 Bangalore, Karnataka, India