Trial | NCT01988558  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    lactic acid ...

  • Study Participants

    51
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 Started
Dec 31
2013
Primary Completion
Aug 31
2016
Study Completion
Sep 30
2016
Last Update
Oct 07
2016
Estimate

Drug DL - Lactic Acid

Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored)

Dietary Supplement Raspberry flavored syrup

Placebo group to receive Raspberry flavored Syrup

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

Criteria 

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.
No Results Posted