CTRI/2021/11/038335进行中(未招募)未知
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
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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