Clinical trial NCT05665777: Chinese Medicine for Treating Chronic Pharyngolaryngitis
Official title: The Effectiveness and Safety of Qingyan Lihou Decoction for the Treatment of Chronic Pharyngolaryngitis: A Randomized, Double-blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Pharyngolaryngitis (Disorder)
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Chronic pharyngolaryngitis (CP), also known as chronic pharyngitis, is defined as the inflammation of the pharynx, which is at the back of the throat. CP is a common disease characterized by dry throat, sore throat, pharyngeal itching, dry cough, and difficulty in swallowing. In Western medicine, common treatment regimens for CP include lozenges, antibiotics, lasers, and cryotherapy. However, the above treatment modalities may not be effective, and the disease is likely to bounce back repeatedly.

Chinese medicine has been used for the treatment of CP for a long time. Many studies have shown that treatment using Chinese herbal medicine is effective in relieving the symptoms of CP.

This study is to evaluate the efficacy and safety of oral Qingyan Lihou Decoction in relieving the clinical symptoms of patients with CP.

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.

Primary outcomes:
measure: The resolution rate of the clinical symptoms of CP
timeFrame: 8 weeks
measure: Improvement of laryngeal signs
timeFrame: 8 weeks
Secondary outcomes:
measure: Complete remission rate of Globus
timeFrame: 8 weeks
measure: Complete remission rate of Globus symptom
timeFrame: 16 weeks
measure: Visual analogue scale (VAS) of Globus symptom
timeFrame: 8 weeks
measure: Visual analogue scale (VAS) of Globus symptom
timeFrame: 16 weeks
measure: Change of Numeric rating scale of sore throat
timeFrame: 8 weeks
measure: Change of Numeric rating scale of sore throat
timeFrame: 16 weeks
measure: Changes of serum level of cytokines
timeFrame: 8 weeks
measure: Changes of serum level of cytokines
timeFrame: 16 weeks
measure: Changes of laryngeal hypersensitivity questionnaire (LHQ)
timeFrame: 8 weeks
measure: Changes of laryngeal hypersensitivity questionnaire (LHQ)
timeFrame: 16 weeks
measure: Changes of oral microbiome
timeFrame: 8 weeks
measure: Changes of oral microbiome
timeFrame: 16 weeks
measure: Changes in Sore Throat Assessment Tool-10 (STAT-10)
timeFrame: 8 weeks
measure: Changes in Sore Throat Assessment Tool-10 (STAT-10)
timeFrame: 16 weeks
measure: Changes in Eating Assessment Tool-10 (EAT-10)
timeFrame: 8 weeks
measure: Changes in Eating Assessment Tool-10 (EAT-10)
timeFrame: 16 weeks
measure: Adverse event related to the study treatment
timeFrame: From baseline to week 16
measure: Changes in 36-Item Short Form Survey Instrument (SF-36)
timeFrame: 8 weeks
measure: Changes in 36-Item Short Form Survey Instrument (SF-36)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Institute of Integrative Medicine
Study officials:
affiliation: Hong Kong Institute of Integrative Medicine
name: Zhixiu Lin
role: PRINCIPAL_INVESTIGATOR
References: