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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-09-30

Brief Summary

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The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.

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Detailed Description

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Conditions

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Recurrent Tonsillitis in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

DL - Lactic Acid

Intervention Type DRUG

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

Placebo Group

Group Type PLACEBO_COMPARATOR

Raspberry flavored syrup

Intervention Type DIETARY_SUPPLEMENT

Placebo group to receive Raspberry flavored Syrup

Interventions

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DL - Lactic Acid

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

Intervention Type DRUG

Raspberry flavored syrup

Placebo group to receive Raspberry flavored Syrup

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No