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Effect of Cistus Plus Infektblocker, Gum Arabic lozenges, and Cistus Echinacea Lozenges in patients with sore throat

A single blind, randomized, comparative prospective clinical study to evaluate the efficacy of a Cistus Plus Infektblocker, Gum Arabic lozenges, and Cistus Echinacea Lozenges in patients with sore throat due to bacterial or viral infection.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/036075
Enrollment
267
Registered
2021-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: J02- Acute pharyngitis

Interventions

Intervention1: Cistus Plus Infektblocker: 5-6 lozenges a day, oral use, upto 5 days Intervention2: Cistus Echinacea Lozenges: 5-6 lozenges a day, oral use, upto 5 days Control Intervention1: Gum Arabi

Sponsors

NUTRIN GmbH
Lead Sponsor
Alsitan GmbH
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects of either sex 2. Male or female aged from18 to 65years 3. Patient with sore throat due to viral or bacterial infection. 4. Are free of any disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events. 5. If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study. 6. Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study. 7. Are willing to avoid participation in any other interventional clinical trial for the duration of this study. 8. Compliance by the patient seems guaranteed, and the patient seems to be able to understand and complete the patient diary.

Exclusion criteria

Exclusion criteria: 1. Severe respiratory tract infection (pneumonia, bronchitis or laryngitis) 2. Covid-19 3. Oro-pharyngeal paresthesia or mycosis 4. Severely traumatized and/or very severe oromucosal inflammation 5. Tonsillo-pharyngectomy 6. Peritonsillar abscess 7. Allergic to Cistus, Echinacea, elderberry, gum Arabic 8. Long term use (>= 3 times per week within the last month or regular intake within the last 3 months before randomization) of anti-inflammatory drugs- Any long-acting or slow release analgesic intake including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)within 24 hours before randomization (e.g. piroxicam or naproxen) 9. Any anti-inflammatory drugs intake by systemic route within 12 hours before randomization 10. Any paracetamol intake within 6 hours before randomization 11. Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomization 12. Any topical throat medication intake containing or not a local oral anesthetic such as lozenge, spray, mouth rinse within 4 hours before randomization 13. Heavy smokers ( >20 cigarettes/day)

Design outcomes

Primary

MeasureTime frame
Cistus Plus Infektblocker Lozenges, Gum Arabic Lozenges and Cistus Echinacea Lozenges for throat infection/pharyngitisTimepoint: Baseline and Day 05

Secondary

MeasureTime frame
physical Layer effect of LozengesTimepoint: Baseline;To assess the safety and tolerabilityTimepoint: Baseline and Day 05

Countries

India

Contacts

Public ContactDr Abhijit Munshi

MITTAL GLOBAL CLINICAL TRIAL SERVICES

drabhijit@mgcts.org8937045757

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026