CTRI/2020/08/027013
Completed
Phase 2
Clinical study to evaluate the Efficacy and safety of ROSELLE in patients with Bronchial asthma and Malnutrition.
DXN Manufacturing India Pvt Ltd0 sites12 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: J454- Moderate persistent asthma
- Sponsor
- DXN Manufacturing India Pvt Ltd
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged 18\-59 years(both sex) suffering from mild and moderate\-persistent bronchial asthma characterized by
- •\-Daily symptoms of asthma
- •\-Nocturnal awakenings more than once per week
- •\-Daily need for SABAs for symptom relief
- •\-More than just minor limitation in normal activity
- •\-FEV1 between 60 and 80 percent of predicted and an FEV/FVC ratio less than the lower confidence interval for normal
Exclusion Criteria
- •Patients with fever, drug\-induced asthma, aspirin intolerance triad, asthma with fixed airflow limitation, asthma with obesity, late\-onset asthma will be excluded.
- •\-History of heart, liver, kidney, or other organ diseases;
- •\-Allergy or intolerance to the individual constituents in NONIZHI
- •\-Subjects who are pregnant and lactating mothers, or with any serious or invalidating other disease limiting full adhesion to the protocol.
- •\-Participation in an investigational drug trial in the 30 days prior to the screening visit.
Outcomes
Primary Outcomes
Not specified
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