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The study objectives are to evaluate Tonsitinâ„¢ (10% Lactic Acid) safety, tolerability and preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated Group | Experimental | Children diagnosed as suffering from recurrent Tonsillitis (at least 4 episodes per year) to receive DL-Lactic acid syrup twice a day for a month. |
|
| Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DL - Lactic Acid | Drug | Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation - Number of participants with adverse events | At 90 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Tonsil Size | Chnge from baseline at 6 months post treatment | |
| Number of Tonsillitis episodes | Chnge in medical history number of recurrent Tonsillitis episodes within 6 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| QOL Questionnaire | Chnge from baseline at 90 days post treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mati Berkovitz, Prof. | MOH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clalit Health Services, Pediatric Community Ambulatory Clinic | Petah Tikva | Israel | Israel | |||
| Clalit Health Services, Pediatric Community Ambulatory Ganei Hadar clinic |
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| Raspberry flavored syrup | Dietary Supplement | Placebo group to receive Raspberry flavored Syrup |
|
| Petah Tikva |
| Israel |
| Israel |
| Assaf Harofeh Medical Center | Tzrifin | Israel |
| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D019344 | Lactic Acid |
| ID | Term |
|---|---|
| D007773 | Lactates |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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