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

NCT01988558 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2016-10-07

No results posted yet for this study

Summary

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

Conditions

  • Recurrent Tonsillitis in Children

Interventions

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

Sponsors & Collaborators

  • Yali Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Mati Berkovitz, Prof. · MOH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-08-31
Completion
2016-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01988558 on ClinicalTrials.gov