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A Phase I/II to Assess Safety, Tolerability and Efficacy of DL-lactic Acid Syrup in Children With Recurrent Tonsillitis

This study has been completed.
Information provided by (Responsible Party):
Yali Pharmaceuticals Identifier:
First received: November 3, 2013
Last updated: October 6, 2016
Last verified: October 2016
The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.

Condition Intervention Phase
Recurrent Tonsillitis in Children Drug: DL - Lactic Acid Dietary Supplement: Raspberry flavored syrup Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I/II, Randomized, Double Blind, Placebo-controlled Study to Assess the Safety, Tolerability and Efficacy of DL-lactic Acid Syrup (Tonsitin) in Children With Recurrent Tonsillitis.

Resource links provided by NLM:

Further study details as provided by Yali Pharmaceuticals:

Primary Outcome Measures:
  • Safety evaluation - Number of participants with adverse events [ Time Frame: At 90 days post treatment ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • QOL Questionnaire [ Time Frame: Chnge from baseline at 90 days post treatment ]

Enrollment: 51
Study Start Date: December 2013
Study Completion Date: September 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treated Group
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.
Drug: DL - Lactic Acid
Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored)
Placebo Comparator: Placebo Group Dietary Supplement: Raspberry flavored syrup
Placebo group to receive Raspberry flavored Syrup


Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children at the ages of 5-16.
  • Patient is suffering from recurrent documented sore throat with at least 4 tonsillitis episodes during the preceding year (at least one verified by culture or rapid antigen testing for Streptococcus A).
  • Patient with clinical presentation of irregular tonsils.
  • Tonsils size graded between 2.5-4.
  • Clinical diagnosis of bacterial known in recurrent pharyngeal-tonsillitis.
  • Patient is willing to participate in the study and adhere to the study protocol
  • Patient's guardian and/or Patient have signed informed consent.

Exclusion Criteria:

  • Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes (Positive RSAT or microbial culture).
  • Subjects who are known as Streptococcus pyogenes carriers
  • Subject's requiring any other medication (topical or systemic) that may affect the course of the disease during the study period (e.g. antibiotics, sedating antihistamines), and/or did not completed 14 days from end of antibiotics treatment.
  • Subjects with known hypersensitivity to lactose.
  • Subject is suffering from peritonsillar abscess.
  • Subject suffers from an active peptic ulcer
  • Subjects who are suffering from any concomitant disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study results.
  • Subject is currently participating in another clinical study.
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Please refer to this study by its identifier: NCT01988558

Clalit Health Services, Pediatric Community Ambulatory Clinic
Petach Tikva, Israel
Clalit Health Services, Pediatric Community Ambulatory Ganei Hadar clinic
Petach Tikva, Israel
Assaf Harofeh Medical Center
Tzrifin, Israel
Sponsors and Collaborators
Yali Pharmaceuticals
Principal Investigator: Mati Berkovitz, Prof. MOH
  More Information

Responsible Party: Yali Pharmaceuticals Identifier: NCT01988558     History of Changes
Other Study ID Numbers: LA-001-IL
Study First Received: November 3, 2013
Last Updated: October 6, 2016

Keywords provided by Yali Pharmaceuticals:
Recurrent Tonsillitis
Streptococcus A

Additional relevant MeSH terms:
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases processed this record on August 22, 2017