Health Condition 1: J980- Diseases of bronchus, not elsewhere classified
Conditions
Interventions
Intervention1: H-15 soft gel capsule: 500 mg once daily after meals with SOC
Intervention2: Sallaki 400mg tablet: One tablet thrice daily consecutively for eight weeks is the duration of therapy.
Inte
Sponsors
Gufic Biosciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male/female of >=18 and 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FEV1 as measured by Spirometry (pulmonary function test) Degree of improvement Change in investigatorâ??s diagnosed clinical symptoms like cough, wheezing, dyspnea and frequency of night attacks Timepoint: From Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 0) at Visit 5, End of study (Day 60) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in force vital capacity (FVC) Change in Asthma Control Test (ACT) score Reduction in episodes of exacerbation Change in Asthma Quality of Life Questionnaire (AQLQ) score Change in Complete Blood Count (CBC), eosinophil count and Erythrocyte Sedimentation Rate (ESR) counts Change in Liver Function Tests (LFTs) parameters, Blood Urea Nitrogen (BUN) level and Creatinine level Number of incidences of Short-Acting Beta-Agonists (SABA) requirement during the study period Number of Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) Timepoint: from Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 0) at Visit 5, End of study (Day 60) | — |
Countries
India
Contacts
Public ContactMr Vairamuthu Ammaiyappan
Gufic Biosciences Limited
Outcome results
None listed