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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 5
- 主要终点
- Degree of improvement
研究概览
简要总结
110 patients with mild to moderate Bronchial Asthma will be included in this study. Patients will be enrolled into the study based on Inclusion & Exclusion Criteria, patient history, and safety measures. The duration of each patient’s participation in the study will be of approximately 60 days. There will be total 05 visits during the study.
Treatment Arm 1: Control group on SOC (Standard of care)
Treatment Arm 2: Sallaki tablets 400 mg thrice daily after meals with SOC
Treatment Arm 3: BS Soft gel capsule 500mg once daily after meals with SOC
Treatment Arm 4: BS Soft gel capsule 500mg twice daily after meals with SOC
Treatment Arm 5: BS Soft gel capsule 500 mg thrice daily after meals with SOC
Patients will be visiting site every 15 days for Visit 2, Visit 3, Visit 4 and Visit 5. Following assessments will be done during these visits:
· Physical examination including vital signs (B.P, body temperature, pulse rate, respiration rate)
· Forced Expiratory Volume in one second (FEV1)
· Peak expiratory flow rate (PEFR)
· Force vital capacity (FVC)
· Assessment of number of episodes of exacerbation
· Asthma Quality of Life Questionnaire (AQLQ)
All patients will undergo clinical laboratory tests for safety at Baseline Day 0 and Visit 5, End of study visit (Day 60)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
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 ˃19 6.Female of childbearing potential must have a negative pregnancy test and be non-lactating at screening visit 7.Patient/ patient’s legally acceptable representative understands and can comply with clinical trial protocol requirements.
排除标准
- •1.Patient Ë‚ 18 or ˃ 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.
结局指标
主要结局
Degree of improvement
时间窗: From Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 0) at Visit 5, End of study (Day 60)
Change in FEV1 as measured by Spirometry (pulmonary function test)
时间窗: From Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 0) at Visit 5, End of study (Day 60)
Change in investigator’s diagnosed clinical symptoms like cough, wheezing, dyspnea and frequency of night attacks
时间窗: From Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 0) at Visit 5, End of study (Day 60)
次要结局
- Change in force vital capacity (FVC)(Change in Asthma Control Test (ACT) score)