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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
Chinese medicine granules
Placebo granules
Hong Kong Institute of Integrative Medicine
Hong Kong, Hong Kong
RECRUITINGThe resolution rate of the clinical symptoms of CP
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.
Time frame: 8 weeks
Improvement of laryngeal signs
Observe the improvement of laryngeal signs via Flexible nasopharyngolaryngoscopy examination
Time frame: 8 weeks
Complete remission rate of Globus
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.
Time frame: 8 weeks
Complete remission rate of Globus symptom
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.
Time frame: 16 weeks
Visual analogue scale (VAS) of Globus symptom
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)
Time frame: 8 weeks
Visual analogue scale (VAS) of Globus symptom
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)
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Time frame: 16 weeks
Change of Numeric rating scale of sore throat
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)
Time frame: 8 weeks
Change of Numeric rating scale of sore throat
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)
Time frame: 16 weeks
Changes of serum level of cytokines
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.
Time frame: 8 weeks
Changes of serum level of cytokines
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.
Time frame: 16 weeks
Changes of laryngeal hypersensitivity questionnaire (LHQ)
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.
Time frame: 8 weeks
Changes of laryngeal hypersensitivity questionnaire (LHQ)
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.
Time frame: 16 weeks
Changes of oral microbiome
The saliva sample will be collected from subjects, and it will be examined according to the protocol of the Microbiome Saliva DNA Kit.
Time frame: 8 weeks
Changes of oral microbiome
The saliva sample will be collected from subjects, and it will be examined according to the protocol of the Microbiome Saliva DNA Kit.
Time frame: 16 weeks
Changes in Sore Throat Assessment Tool-10 (STAT-10)
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.
Time frame: 8 weeks
Changes in Sore Throat Assessment Tool-10 (STAT-10)
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.
Time frame: 16 weeks
Changes in Eating Assessment Tool-10 (EAT-10)
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.
Time frame: 8 weeks
Changes in Eating Assessment Tool-10 (EAT-10)
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.
Time frame: 16 weeks
Adverse event related to the study treatment
Any adverse event will be recorded during the study period, it will be graded by CTCAE.
Time frame: From baseline to week 16
Changes in 36-Item Short Form Survey Instrument (SF-36)
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.
Time frame: 8 weeks
Changes in 36-Item Short Form Survey Instrument (SF-36)
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.
Time frame: 16 weeks