Effects of Jing Si Herbal Tea on Quality of Life and Sleep in Dementia and Their Caregivers

April 7, 2026 updated by: Chung-Ying Lin, National Cheng Kung University

Effects of Jing Si Herbal Tea on Quality of Life and Sleep Among Patients With Dementia and Their Caregivers: A Randomized Controlled Trial

Jing Si Herbal Tea has been found to be effective in improving health for the conditions of cancers, aging, depression, and sleep. Such evidence has been shown in animal models and clinical research with publications in the international journals. However, empirical evidence regarding the effectiveness of Jing Si Herbal Tea for patients with dementia and their caregivers on their quality of life and psychosocial health remains unclear. Therefore, the present project aims to investigate the feasibility of taking Jing Si Herbal Tea among patients with dementia; then, to investigate if Jing Si Herbal Tea could improve quality of life and psychosocial health for patients with dementia and their caregivers. The project will be three years. The first year will examine the feasibility for the patients with dementia. A total of 100 patients with dementia will be recruited and they will be informed to take the Jing Si Herbal Tea two times per day (one time in the morning and another time in the afternoon). All the participants will be measured for their quality of life and psychosocial health at baseline, three months after baseline, and six months after baseline, to have initial evidence of the improvements in quality of life and psychosocial health without having a control group. The second year will recruit 200 patients with dementia and randomly assign them into a treatment group (taking Jing Si Herbal Tea) and a control group (taking placebo). All the participants will be measured for their quality of life and psychosocial health at baseline, three months after baseline, and six months after baseline, to investigate the strong evidence of Jing Si Herbal Tea on quality of life and psychosocial health. The third year will recruit 200 caregivers of patient with dementia and randomly assign them into a treatment group (taking Jing Si Herbal Tea) and a control group (taking placebo). All the participants will be measured for their quality of life and psychosocial health at baseline, three months after baseline, and six months after baseline, to investigate the strong evidence of Jing Si Herbal Tea on quality of life and psychosocial health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Hualien City, Taiwan
        • Recruiting
        • Tzu-Chi General Hospital
        • Contact:
          • Hao-Ming Li, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

For people with dementia:

Inclusion Criteria:

  • diagnosis of dementia
  • 50 years or older
  • with sufficient cognition to complete the questionnaires
  • can communicate using Mandarin or Taiwanese

Exclusion Criteria:

  • with renal function problems
  • not suitable for Jing Si Herbal Tea after evaluation from a psychiatrist/physician
  • with the condition of change the commencement of guardianship (or commencement of assistance)

For caregivers:

Inclusion Criteria:

  • caregivers of people with dementia for more than half years
  • 20 years or older
  • with sufficient cognition to complete the questionnaires
  • can communicate using Mandarin or Taiwanese

Exclusion Criteria:

  • with renal function problems
  • not suitable for Jing Si Herbal Tea after evaluation from a psychiatrist/physician
  • with the condition of change the commencement of guardianship (or commencement of assistance)

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Jing Si Herbal Tea Group
Frequency: Two times of herbal tea (one in the morning; one in the afternoon) per day Duration: Consumption for three months Dosage: One pack (14g) with 600 ml water for each time of herbal tea consumption
Dietary supplement: Jing Si Herbal Tea
Consuming Jing Si Herbal Tea for three months; twice per day with each time 14 g of Jing Si Herbal in 600 ml water

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
World Health Organization Quality of Life Assessment for age (WHOQOL-AGE) [for people with dementia]
Time Frame: baseline; 3 months after baseline; 6 months after baseline
quality of life measure; score range 13-65; higher score indicates better quality of life
baseline; 3 months after baseline; 6 months after baseline
Insomnia Severity Index [for both people with dementia and their caregivers]
Time Frame: baseline; 3 months after baseline; 6 months after baseline
sleep problem measure; score range 0-28; higher score indicates more severe insomnia
baseline; 3 months after baseline; 6 months after baseline
World Health Organization Quality of Life Assessment brief version (WHOQOL-BREF) [for caregivers]
Time Frame: baseline; 3 months after baseline; 6 months after baseline
quality of life measure; score range 4-20; higher score indicates better quality of life
baseline; 3 months after baseline; 6 months after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Katz Index of Independence in Activities of Daily Living [for people with dementia]
Time Frame: baseline; 3 months after baseline; 6 months after baseline
activities of daily living function measure; score range 0-6; higher score indicates better activities of daily living
baseline; 3 months after baseline; 6 months after baseline
5 items of Geriatric Depression Scale [for people with dementia and their caregivers]
Time Frame: baseline; 3 months after baseline; 6 months after baseline
depression measure; score range 0-5; higher score indicates greater depression
baseline; 3 months after baseline; 6 months after baseline
Short Portable Mental Status Questionnaire [for people with dementia]
Time Frame: baseline; 3 months after baseline; 6 months after baseline
cognition measure; score range 0-10; higher score indicates poor cognition
baseline; 3 months after baseline; 6 months after baseline
Clinical Frailty Scale [for people with dementia]
Time Frame: baseline; 3 months after baseline; 6 months after baseline
frailty measure; score range 1-9; higher score indicates more frail
baseline; 3 months after baseline; 6 months after baseline
Integrated care for older people [for people with dementia]
Time Frame: baseline; 3 months after baseline; 6 months after baseline
intrinsic capacity measure; score range 0-13; higher score indicates poorer intrinsic capacity
baseline; 3 months after baseline; 6 months after baseline
Attitude and Thoughts Toward Older People Scale [for people with dementia and their caregivers]
Time Frame: baseline; 3 months after baseline; 6 months after baseline
ageism measure; score range 17-85; higher score indicates higher level of ageism
baseline; 3 months after baseline; 6 months after baseline
Depression, Anxiety, Stress Scale-21 [for people with dementia and their caregivers]
Time Frame: baseline; 3 months after baseline; 6 months after baseline
psychological distress measure; score range 0-63; higher score indicates greater distress
baseline; 3 months after baseline; 6 months after baseline
12 item of Zarit Burden Interview [for caregivers]
Time Frame: baseline; 3 months after baseline; 6 months after baseline
caregiver burden measure; score range 0-48; higher score indicates greater burden
baseline; 3 months after baseline; 6 months after baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comorbidity
Time Frame: baseline
Other chronic disease the participants have
baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cheng Kung University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Buddhist Tzu Chi General Hospital
E-DA Hospital
Tzu Chi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hao-Ming Li, MD, Buddhist Tzu Chi General Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCMF-JCT 113-03

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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