Effect of Jing Si Herbal Tea Liquid Packets on Chronic Pharyngolaryngitis

March 25, 2024 updated by: Dalin Tzu Chi General Hospital

Effect of Jing Si Herbal Tea Liquid Packets on Chronic Pharyngolaryngitis: A Randomized, Double-blinded Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Chiayi City, Taiwan, 66247
        • Recruiting
        • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
placebo: 2 times a day, 1 sachet each time.
Other: control group
2 times a day, 1 sachet each time.
Other Names:
  • Placebo
Experimental: Jing Si herbal tea liquid packets group
Jing Si herbal tea liquid packets: 2 times a day, 1 sachet each time.
Other: Jing Si herbal tea liquid packets
2 times a day, 1 sachet each time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health questionnaire
Time Frame: Before the test begins and after intervention completed (at 1 month)
the recording items are as follows: age, gender, height, weight, waist circumference, disease history, smoking or not (quantification), drinking or not (quantification), and eating betel nut or not (quantification) , sleeping status, whether to drink coffee (quantification)
Before the test begins and after intervention completed (at 1 month)
Reflux Symptom Index (RSI)
Time Frame: Before the test begins and after intervention completed (at 1 month)

The Reflux Symptom Index (RSI) is in common use as a semi-quantitative tool to assess symptoms associated with laryngopharyngeal reflux (LPR).

RSI is a scoring tool that consists of nine items used to assess various symptoms associated with LPR. Each item has a scale ranging from zero (no complaints) to five (severe complaints), with a maximum of 45 indicating the most severe symptoms.
Before the test begins and after intervention completed (at 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalin Tzu Chi General Hospital

Investigators

  • Study Chair: Juen-Haur Hwang, MD, PhD, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A11203001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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