NCT06331351

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Feb 2024Dec 2026

Study Start

First participant enrolled

February 22, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

March 8, 2024

Last Update Submit

February 5, 2026

Conditions

Keywords

Chronic pharyngitisJing Si herbal tea liquid packetsclinical trial

Outcome Measures

Primary Outcomes (2)

  • Health questionnaire

    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)

    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)

Study Arms (2)

control group

PLACEBO COMPARATOR

placebo: 2 times a day, 1 sachet each time.

Other: control group

Jing Si herbal tea liquid packets group

EXPERIMENTAL

Jing Si herbal tea liquid packets: 2 times a day, 1 sachet each time.

Other: Jing Si herbal tea liquid packets

Interventions

2 times a day, 1 sachet each time.

Also known as: Placebo
control group

2 times a day, 1 sachet each time.

Jing Si herbal tea liquid packets group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Chiayi City, 66247, Taiwan

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Juen-Haur Hwang, MD, PhD

    Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    STUDY CHAIR

Central Study Contacts

Juen-Haur Hwang, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 26, 2024

Study Start

February 22, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations