Clinical trial NCT06331351: Effect of Jing Si Herbal Tea Liquid Packets on Chronic Pharyngolaryngitis
Official title: Effect of Jing Si Herbal Tea Liquid Packets on Chronic Pharyngolaryngitis: A Randomized, Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pharyngitis
Keywords: Chronic pharyngitis
Jing Si herbal tea liquid packets
clinical trial
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Chronic pharyngolaryngitis is common and often make people suffer in many aspects. The etiology is numerous, for example, airway hypersensitivity, gastroesophageal acid regurgitation, sicca syndrome, anxiety, etc.

The investigators aimed to investigate the effect of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis by a design of randomized, double-blind clinical trial in this study. The subjects who were bed-ridden, without self-care ability, receiving hemodialysis, no idea about the details of this study, poor compliance for this study, alcohol and/or drugs additives, pregnancy and breast-feeding women were excluded from this study.

A questionnaire for health and habits was performed at the start of the study, and a questionnaire for Reflux Symptom Index (RSI) was performed at the start and the end of the study. Finally, Student's t-test was used to test the difference between the Jing Si herbal tea group and the control group. And, multivariate linear regression was used to test the violation of clinical factors on the treatment outcome of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis.

Detailed description: Chronic pharyngolaryngitis is common and often make people suffer in many aspects. The etiology is numerous, for example, airway hypersensitivity, gastroesophageal acid regurgitation, sicca syndrome, anxiety, etc.

The investigators aimed to investigate the effect of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis by a design of randomized, double-blind clinical trial in this study. One hundred and twenty adults of both sex with a range of age between of 20-70 years old were included. All participants were divided randomly into two groups. Jing Si herbal tea group received 1 pack of Jing Si herbal tea liquid packet twice a day for 1 month (30 days), and the control group received 1 pack of control liquid packet twice a day for 1 month (30 days). The subjects who were bed-ridden, without self-care ability, receiving hemodialysis, no idea about the details of this study, poor compliance for this study, alcohol and/or drugs additives, pregnancy and breast-feeding women were excluded from this study.

A questionnaire for health and habits was performed at the start of the study, and a questionnaire for Reflux Symptom Index (RSI) was performed at the start and the end of the study. Finally, Student's t-test was used to test the difference between the Jing Si herbal tea group and the control group. And, multivariate linear regression was used to test the violation of clinical factors on the treatment outcome of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis.

Eligibility criteria: Inclusion Criteria:

1. Adult men and women aged 20 to 70 years old.
2. Patients with chronic pharyngitis

Exclusion Criteria:

1. Patients who are bedridden or unable to take care of themselves.
2. Dialysis patients.
3. Patients who cannot understand the details of this study or cannot cooperate with the examination.
4. History of alcohol or drug abuse.
5. Pregnant and lactating women

Primary outcomes:
measure: Health questionnaire
timeFrame: Before the test begins and after intervention completed (at 1 month)
measure: Reflux Symptom Index (RSI)
timeFrame: Before the test begins and after intervention completed (at 1 month)
Secondary outcomes:
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study officials:
affiliation: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
name: Juen-Haur Hwang, MD, PhD
role: STUDY_CHAIR
References: