Hong Kong Institute of Integrative Medicine
Hong Kong
Location status: Recruiting
Recruiting
NCT Number: NCT05665777
Chinese Medicine for Treating Chronic Pharyngolaryngitis
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Qingyan Lihou Decoction
DrugChinese medicine granules
Other names: Active treatment
Placebo
OtherPlacebo granules
Primary outcomes
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The resolution rate of the clinical symptoms of CP
Time frame: 8 weeks
Measure the resolution rate of the clinical symptoms at week 8. According to the "Guiding Principles for Clinical Research of Chinese Medicines", the degree of clinical symptom is divided into 4 grades: asymptomatic, mild symptom, moderate symptom, and severe symptom, with a score of 0~3.
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Improvement of laryngeal signs
Time frame: 8 weeks
Observe the improvement of laryngeal signs via Flexible nasopharyngolaryngoscopy examination
Secondary outcomes
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Complete remission rate of Globus
Time frame: 8 weeks
The rate of remission of the main clinical symptom Globus at week 8. According to the "Guiding Principles for Clinical Research of Chinese Medicines" [16], the degree of clinical symptom is divided into 4 grades: asymptomatic, mild symptom, moderate symptom, and severe symptom, with a score of 0~3.
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Complete remission rate of Globus symptom
Time frame: 16 weeks
The rate of remission of main clinical symptom Globus at week 16. According to the "Guiding Principles for Clinical Research of Chinese Medicines" [16], the degree of clinical symptom is divided into 4 grades: asymptomatic, mild symptom, moderate symptom, and severe symptom, with a score of 0~3.
-
Visual analogue scale (VAS) of Globus symptom
Time frame: 8 weeks
Difficulty in swallowing is assessed using a VAS, which is 100 mm in length (100-mm VAS) anchored by two verbal descriptors, one for each extreme symptom (0 mm = not difficult, 100 mm = very difficult)
-
Visual analogue scale (VAS) of Globus symptom
Time frame: 16 weeks
Difficulty in swallowing is assessed using a VAS, which is 100 mm in length (100-mm VAS) anchored by two verbal descriptors, one for each extreme symptom (0 mm = not difficult, 100 mm = very difficult)
-
Change of Numeric rating scale of sore throat
Time frame: 8 weeks
Intensity of sore throat will be assessed using an 11-point numeric rating scale (11-point NRS) with 0 representing one pain extreme (no pain) and 10 representing the other pain extreme (most severe pain)
-
Change of Numeric rating scale of sore throat
Time frame: 16 weeks
Intensity of sore throat will be assessed using an 11-point numeric rating scale (11-point NRS) with 0 representing one pain extreme (no pain) and 10 representing the other pain extreme (most severe pain)
-
Changes of serum level of cytokines
Time frame: 8 weeks
Blood samples will be taken to detect the serum level of C reactive protein (CRP), Erythrocyte Sedimentation Rate (ESR), Complete blood count (CBC), White blood cell (WBC), and Antinuclear antibody (ANA) using enzyme-linked immunosorbent assay (ELISA) kits. These are the markers for inflammatory response and severity. The higher the value, the more severity of the symptoms.
-
Changes of serum level of cytokines
Time frame: 16 weeks
Blood samples will be taken to detect the serum level of C reactive protein (CRP), Erythrocyte Sedimentation Rate (ESR), Complete blood count (CBC), White blood cell (WBC), and Antinuclear antibody (ANA) using enzyme-linked immunosorbent assay (ELISA) kits. These are the markers for inflammatory response and severity. The higher the value, the more severity of the symptoms.
-
Changes of laryngeal hypersensitivity questionnaire (LHQ)
Time frame: 8 weeks
LHQ contains 14 items with a 7-point Likert frequency response scale where 1 equates to all of the time and 7 equates to none of the time. 14 items will be divided into 3 categories, which is obstruction, pain and throat tickle. Average score of each category will be obtained and the total LHQ score will be the sum of those average scores.
-
Changes of laryngeal hypersensitivity questionnaire (LHQ)
Time frame: 16 weeks
LHQ contains 14 items with a 7-point Likert frequency response scale where 1 equates to all of the time and 7 equates to none of the time. 14 items will be divided into 3 categories, which is obstruction, pain and throat tickle. Average score of each category will be obtained and the total LHQ score will be the sum of those average scores.
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Changes of oral microbiome
Time frame: 8 weeks
The saliva sample will be collected from subjects, and it will be examined according to the protocol of the Microbiome Saliva DNA Kit.
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Changes of oral microbiome
Time frame: 16 weeks
The saliva sample will be collected from subjects, and it will be examined according to the protocol of the Microbiome Saliva DNA Kit.
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Changes in Sore Throat Assessment Tool-10 (STAT-10)
Time frame: 8 weeks
The STAT-10 is the first validated tool for measuring the intensity and duration of symptoms from the perspective of sore throat patients and for quantifying and comparing different treatment modalities in acute pharyngotonsillitis (APT) patients. STAT-10 contains 10-item questionnaire using a five-point Likert scale. The higher the score, the more severity of the symptoms.
-
Changes in Sore Throat Assessment Tool-10 (STAT-10)
Time frame: 16 weeks
The STAT-10 is the first validated tool for measuring the intensity and duration of symptoms from the perspective of sore throat patients and for quantifying and comparing different treatment modalities in acute pharyngotonsillitis (APT) patients. STAT-10 contains 10-item questionnaire using a five-point Likert scale. The higher the score, the more severity of the symptoms.
-
Changes in Eating Assessment Tool-10 (EAT-10)
Time frame: 8 weeks
It consists of ten statements that a patient rates on a scale of 0-4, with 0=no problem to 4=severe problem. The score is 0 to 40. The higher the score, the more severity of the swallowing difficulty.
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Changes in Eating Assessment Tool-10 (EAT-10)
Time frame: 16 weeks
It consists of ten statements that a patient rates on a scale of 0-4, with 0=no problem to 4=severe problem. The score is 0 to 40. The higher the score, the more severity of the swallowing difficulty.
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Adverse event related to the study treatment
Time frame: From baseline to week 16
Any adverse event will be recorded during the study period, it will be graded by CTCAE.
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Changes in 36-Item Short Form Survey Instrument (SF-36)
Time frame: 8 weeks
It will be used to assess the patient's health status using 8 different dimensions including vitality, physical functioning, bodily pain, general health perceptions, role limitations due to physical health, role limitations due to emotional health, social role functioning and mental health. The possible score ranges from 0 to 100 points whereby 0 points represent the greatest possible limitation of health, while 100 points represent the absence of health restrictions.
-
Changes in 36-Item Short Form Survey Instrument (SF-36)
Time frame: 16 weeks
It will be used to assess the patient's health status using 8 different dimensions including vitality, physical functioning, bodily pain, general health perceptions, role limitations due to physical health, role limitations due to emotional health, social role functioning and mental health. The possible score ranges from 0 to 100 points whereby 0 points represent the greatest possible limitation of health, while 100 points represent the absence of health restrictions.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Chinese University of Hong Kong
Other
Registry information
Official study title
The Effectiveness and Safety of Qingyan Lihou Decoction for the Treatment of Chronic Pharyngolaryngitis: A Randomized, Double-blinded, Placebo-controlled Trial
Important dates
- Study start
- 2023
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Dec 27, 2022
- Registry last updated
- Jul 30, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.