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Recruiting NCT05665777

Chinese Medicine for Treating Chronic Pharyngolaryngitis

Phase II Interventional Chronic Pharyngolaryngitis (Disorder)

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Qingyan Lihou Decoction, Placebo.
Who it may be relevant to
Registry conditions: Chronic Pharyngolaryngitis (Disorder). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effectiveness and Safety of Qingyan Lihou Decoction for the Treatment of Chronic Pharyngolaryngitis: A Randomized, Double-blinded, Placebo-controlled Trial

Overview

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.

Interventions

  • Drug Qingyan Lihou Decoction
    Chinese medicine granules
  • Other Placebo
    Placebo granules

Primary outcome measures

  • The resolution rate of the clinical symptoms of CP [Time frame: 8 weeks]
  • Improvement of laryngeal signs [Time frame: 8 weeks]
Secondary outcome measures (12)
  • Complete remission rate of Globus [Time frame: 8 weeks]
  • Complete remission rate of Globus symptom [Time frame: 16 weeks]
  • Visual analogue scale (VAS) of Globus symptom [Time frame: 8 weeks]
  • Visual analogue scale (VAS) of Globus symptom [Time frame: 16 weeks]
  • Change of Numeric rating scale of sore throat [Time frame: 8 weeks]
  • Change of Numeric rating scale of sore throat [Time frame: 16 weeks]
  • Changes of serum level of cytokines [Time frame: 8 weeks]
  • Changes of serum level of cytokines [Time frame: 16 weeks]
  • Changes of laryngeal hypersensitivity questionnaire (LHQ) [Time frame: 8 weeks]
  • Changes of laryngeal hypersensitivity questionnaire (LHQ) [Time frame: 16 weeks]
  • Changes of oral microbiome [Time frame: 8 weeks]
  • Changes of oral microbiome [Time frame: 16 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Hong Kong Institute of Integrative Medicine — Hong Kong

Identifiers

NCT: NCT05665777 · CP study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗