Clinical Trial for Assessment of Safety and Efficacy of a Echinacea/Sage Spray Compared to a Chlorhexidine/Lidocaine Spray in the Treatment of Acute Sore Throats

Multicentric Randomized Double Blind Double Dummy Placebo Controlled Clinical Trial for Assessment of Safety and Efficacy of a Echinacea/Sage Spray in Comparison to a Chlorhexidine/Lidocaine Spray in the Treatment of Acute Sore Throats

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00707902

Enrollment

154

Registered

2008-07-01

Start date

2006-02-28

Completion date

2006-08-31

Last updated

2008-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharyngitis

Keywords

Sore throats,, Pharyngitis, Acute

Brief summary

The aim of the study is to show non-inferiority of an echinacea/sage spray compared to a chlorhexidine/lidocaine-spray in the treatment of acute sore throat during five days of treatment. Main outcome parameter is the non-inferiority in number of responders between the two treatment groups. A responder is defined as a reduction by 50% of the total baseline score taken prior to treatment start. The symptoms are assessed with a symptom score.

Detailed description

Further secondary parameters are : Responders during at day 4 and 5, single symptom scores during 1 to 5 days of observation, pain at begin and end (100mm VAS), assessment of efficacy by physician and patient, consumption of rescue medication Assessment of safety by physician and patient, frequency of adverse events

Interventions

DRUGchlorhexidine/lidocaine

DRUGechinacea/sage

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Age \> 12 years; * Acute pharyngitis or tonsillitis with symptoms of throat pain and inflammation of the pharynx and/or tonsils; * Onset of sore throat less than 72 hours before inclusion ; * A Tonsillopharyngitis Severity Score ≥6; * Written informed consent.

Exclusion criteria

* Analgesics \<12 hours; * Antibiotics \<24 hours; t * Topical throat pain medication \<4 hours; * Systemic corticosteroids within the last month; * Symptoms of primary bacterial pharyngitis or secondary bacterial infection; * Serious illness such as tumors; allergy to one of the ingredients; pregnancy or lactation; * Hypersensitivity to ibuprofen; * Participation in another clinical trial in the previous 30 days.

Design outcomes

Primary

Measure	Time frame
comparison of responder of the two treatment groups after the first, second, and third days. A responder is defined as a reduction by 50% of the total baseline score taken prior to treatment start.	first three days of treatment

Secondary

Measure	Time frame
Comparison of response rates after 4th and 5th days of treatment; VAS throat pain; amount rescue medication used; global assessment efficacy Frequency of adverse events, global assessment of tolerability	five days of treatment

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026