Using Chinese medicine to treat chronic throat inflammation
The Effectiveness and Safety of Qingyan Lihou Decoction for the Treatment of Chronic Pharyngolaryngitis: A Randomized, Double-blinded, Placebo-controlled Trial
This study is testing a Chinese herbal treatment for chronic throat inflammation to see if it helps people feel better compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05665777 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Qingyan Lihou Decoction, a Chinese herbal formula, in treating chronic pharyngolaryngitis. Participants will be randomly assigned to receive either the herbal treatment or a placebo for 8 weeks, followed by an 8-week post-treatment assessment. The study aims to address the persistent symptoms of chronic pharyngolaryngitis, which often do not respond well to conventional treatments. The trial will involve Chinese subjects aged 18 and older who have been diagnosed with specific Chinese medicine syndromes related to their condition.
Who should consider this trial
Good fit: Ideal candidates are Chinese adults aged 18 and older with persistent symptoms of pharyngitis for more than 3 weeks.
Not a fit: Patients with severe medical conditions or those currently using certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from chronic pharyngolaryngitis.
How similar studies have performed: Previous studies have indicated that Chinese herbal medicine can effectively relieve symptoms of chronic pharyngolaryngitis, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hong Kong
- Hong Kong Institute of Integrative Medicine — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Zhixiu Lin — Hong Kong Institute of Integrative Medicine
- Study coordinator: Cho Wing Lo
- Email: louislo@cuhk.edu.hk
- Phone: 35053476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.