An Open Label, Randomized, Parallel, Multi-center, Five-Arm, Comparative Clinical Study to Assess the Efficacy and Safety of H-15 (Boswellia serrata) Soft Gel Capsules and Sallaki tablets 400 mg in Comparison with Standard of Care (SOC) in Patients Suffering from Mild to Moderate Bronchial Asthma

Gufic Biosciences Limited0 sites0 target enrollmentStarted: TBDLast updated: November 21, 2022

Trial Snapshot

No summary available.

•1.Male/female of >=18 and <=60 years of age
•2.Patient who can and willing to provide written Informed Consent
•3.Patient with an established diagnosis of mild to moderate bronchial asthma (FEV1 between 60 and 80%)
•4.Patient with mild asthma under the treatment with low dose of Inhaled Corticosteroids (ICS) ICS-formoterol alone and patients with moderate asthma under the treatment of low or medium dose ICS-LABA (Long-Acting Beta-Agonist)
•5.Patient with ACT (Asthma control test) score Ë?19
•6.Female of childbearing potential must have a negative pregnancy test and be non-lactating at screening visit
•7.Patient/ patientâ??s legally acceptable representative understands and can comply with clinical trial protocol requirements

•1.Patient Ë? 18 or Ë? 60 years of age
•2.Pregnant and/or nursing woman
•3.Patient with severe or unstable bronchial asthma or having acute asthmatic attack at the time of enrolment
•4.Patient with a clinically relevant respiratory tract infection in the four weeks prior to enrolment
•5.Patient with any other clinically significant illness
•6.Patient with a history of hypersensitivity to any of the components of the study medications
•7.Patient who has participated in another trial with an investigational drug within 1 month prior to this trial.
•8.Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol

Sponsor