The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
51
Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored)
Placebo group to receive Raspberry flavored Syrup
Clalit Health Services, Pediatric Community Ambulatory Clinic
Petah Tikva, Israel, Israel
Clalit Health Services, Pediatric Community Ambulatory Ganei Hadar clinic
Petah Tikva, Israel, Israel
Assaf Harofeh Medical Center
Tzrifin, Israel
Safety evaluation - Number of participants with adverse events
Time frame: At 90 days post treatment
Tonsil Size
Time frame: Chnge from baseline at 6 months post treatment
Number of Tonsillitis episodes
Time frame: Chnge in medical history number of recurrent Tonsillitis episodes within 6 months post treatment
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