Back to resultsChinese Medicine for Treating Chronic Pharyngolaryngitis
Primary Purpose
Chronic Pharyngolaryngitis (Disorder)
Status
Recruiting
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Qingyan Lihou Decoction
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pharyngolaryngitis (Disorder)
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.
Sites / Locations
- Hong Kong Institute of Integrative MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active treatment (Qingyan Lihou Decoction)
Placebo
Arm Description
It consists of 22 kinds of Chinese medicine as ingredients. It was prepared in granule form.
The placebo medication is composed of starch and an edible pigment and will be matched as closely as possible to the appearance and taste of Qingyan Lihou Decoction granules.
Outcomes
Primary Outcome Measures
The 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.
Improvement of laryngeal signs
Observe the improvement of laryngeal signs via Flexible nasopharyngolaryngoscopy examination
Secondary Outcome Measures
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.
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.
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)
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Adverse event related to the study treatment
Any adverse event will be recorded during the study period, it will be graded by CTCAE.
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.
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.
Full Information
NCT ID
NCT05665777
First Posted
December 18, 2022
Last Updated
July 5, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05665777
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pharyngolaryngitis (Disorder)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active treatment (Qingyan Lihou Decoction)
Arm Type
Experimental
Arm Description
It consists of 22 kinds of Chinese medicine as ingredients. It was prepared in granule form.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo medication is composed of starch and an edible pigment and will be matched as closely as possible to the appearance and taste of Qingyan Lihou Decoction granules.
Intervention Type
Drug
Intervention Name(s)
Qingyan Lihou Decoction
Other Intervention Name(s)
Active treatment
Intervention Description
Chinese medicine granules
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo granules
Primary Outcome Measure Information:
Title
The resolution rate of the clinical symptoms of CP
Description
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
Title
Improvement of laryngeal signs
Description
Observe the improvement of laryngeal signs via Flexible nasopharyngolaryngoscopy examination
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Complete remission rate of Globus
Description
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
Title
Complete remission rate of Globus symptom
Description
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
Title
Visual analogue scale (VAS) of Globus symptom
Description
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
Title
Visual analogue scale (VAS) of Globus symptom
Description
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
16 weeks
Title
Change of Numeric rating scale of sore throat
Description
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
Title
Change of Numeric rating scale of sore throat
Description
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
Title
Changes of serum level of cytokines
Description
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
Title
Changes of serum level of cytokines
Description
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
Title
Changes of laryngeal hypersensitivity questionnaire (LHQ)
Description
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
Title
Changes of laryngeal hypersensitivity questionnaire (LHQ)
Description
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
Title
Changes of oral microbiome
Description
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
Title
Changes of oral microbiome
Description
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
Title
Changes in Sore Throat Assessment Tool-10 (STAT-10)
Description
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
Title
Changes in Sore Throat Assessment Tool-10 (STAT-10)
Description
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
Title
Changes in Eating Assessment Tool-10 (EAT-10)
Description
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
Title
Changes in Eating Assessment Tool-10 (EAT-10)
Description
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
Title
Adverse event related to the study treatment
Description
Any adverse event will be recorded during the study period, it will be graded by CTCAE.
Time Frame
From baseline to week 16
Title
Changes in 36-Item Short Form Survey Instrument (SF-36)
Description
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
Title
Changes in 36-Item Short Form Survey Instrument (SF-36)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cho Wing Lo
Phone
35053476
Email
louislo@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhixiu Lin
Organizational Affiliation
Hong Kong Institute of Integrative Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong Institute of Integrative Medicine
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhixiu LIN
Phone
28733252
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chinese Medicine for Treating Chronic Pharyngolaryngitis
We'll reach out to this number within 24 hrs