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 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年11月21日

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•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

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