Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis
|ClinicalTrials.gov Identifier: NCT03584724|
Recruitment Status : Active, not recruiting
First Posted : July 12, 2018
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Uveitis||Drug: Norflo Oro Drug: Placebo for Norflo Oro||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Up to 60 eligible patients will be randomly assigned to NORFLO® ORO or placebo treatment groups in a 1:1 ratio using a stratified randomization blocks scheme.|
|Official Title:||Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis: a Multicenter Randomized, Placebo Controlled, Double-blind Clinical Study|
|Actual Study Start Date :||December 19, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Norflo Oro
Box of 30 packets of Norflo Oro. The study subject will take the entire content of one packet with meal twice per day. The study subject will be evaluated in a total of three visits.
Drug: Norflo Oro
Norflo Oro is highly bioavailable curcumin complexed into phytosomes
Other Name: Meriva
Placebo Comparator: Placebo for Norflo Oro
Box of 30 packets of Placebo. The study subject will take the entire content of one packet with meal twice per day. The study subject will be evaluated in a total of three visits.
Drug: Placebo for Norflo Oro
Placebo consist of look-alike single foil pouches without active ingredient of Norflo.
Other Name: Placebo
- The reduction of the mean number of relapses per patient between the year before treatment and the study period. [ Time Frame: 12 months ]The primary statistical hypothesis to be assessed in this study is whether there is a difference in cell damage and inflammation reduction between the treatment group and placebo group. The cell damage and inflammation reduction will be measured by Laser Flare Meter.
- The improvement of side effects due to HLA-B27-associated uveitis [ Time Frame: 12 months ]The improvement of side effects due to HLA-B27-associated uveitis, such as intraocular pressure between NORFLO® ORO treatment group and control group.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584724
|United States, Florida|
|Bascom Palmer Eye Institute|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Pia Allegri||S.S. Uveitis Center, Rapallo Hospital, Genoa- Italy|