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Recruiting
NCT05665777
Chinese Medicine for Treating Chronic Pharyngolaryngitis
Conditions: Chronic Pharyngolaryngitis (Disorder)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 74
Sponsor: Chinese University of Hong Kong
Location: Hong Kong Institute of Integrative Medicine Hong Kong
Summary
A randomized, double-blinded, placebo-controlled clinical trial using a Chinese Medicine formula in treating Chronic pharyngolaryngitis. Subjects will be randomized into a treatment group or placebo group for 8 weeks, and then followed by an 8-week post-treatment visit.
Eligibility Criteria
Inclusion Criteria:
* 18 years of age or above (Chinese subjects only);
* Persistent symptoms of pharyngitis (sore throat, globus, dry throat, dry cough, throat irritation) for more than 3 weeks;
* Determined to be the following Chinese medicine syndromes by Registered Chinese Medicine Practitioners (RCMPs): Wind-heat invading the upper-jiao, or phlegm heat or Yin deficiency;
* Visual analog scale (VAS) score for pain ≥ 50 mm;
* Numeric rating scale (NRS) ≥ 6; and
* Be able to give voluntary written informed consent.
Exclusion Criteria:
* Known severe medical conditions, such as cardiovascular, liver or renal dysfunction, diabetes mellitus, cancers, cerebrovascular diseases, blood system diseases;
* Concomitant use of steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants, and immunotherapy within the past week;
* Impaired hematological profile and liver / renal function exceed the upper limit of the reference value by 2 times;
* Known Allergic rhinitis;
* Known Gastroesophageal Reflux Disease (GERD);
* Known cancer or suspected cancer of throat/oesophagus;
* Mechanical obstruction of the throat accountable for the symptoms;
* Known alcohol and/or drug abuse;
* Known allergic history to any Chinese herbal medicines; and
* Subjects who are known pregnant or lactating.
Source: ClinicalTrials.gov (NCT05665777). StuddyBuddy aggregates publicly available trial information.