A Phase 3 interventional study of Luffa Operculate Nasal Solution 5mg/mL and Saline Solution (NaCl 0,9%) in Rhinitis and Sinusitis, sponsored by Zurita Laboratorio Farmaceutico Ltda.. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2010-11-25.
Sponsored by Zurita Laboratorio Farmaceutico Ltda. · Phase 3, Interventional, and Treatment
Sixty subjects will take part in this study. The subjects will be randomly assigned in a 1:1 ratio between the two arms of study. (Group A: Solution of Luffa Nasal Operculate 5mg/mL, Group B: saline).
The subjects will use the study medication or comparative, according to their randomization, for a treatment period of 3 to 7 days. A follow-up visit will be made 15 days after initiation of treatment.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's planned enrollment of 60 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Zurita Laboratorio Farmaceutico Ltda. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
Drug: Luffa Operculate Nasal Solution 5mg/mL
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
Drug: Saline Solution (NaCl 0,9%)
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
Improvement of nasal congestion
If the patient present a improvement of nasal congestion 3 days after the treatment start, the treatment will be discontinued and the patient will perfomr the Visit 2.
Time frame: 3 days
This study is status unknown, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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Zurita Laboratorio Farmaceutico Ltda.