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

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: Recruiting
• Conditions: Quality of Life; Dementia; Caregiver Burden
• Intervention / Treatment: Dietary supplement: Jing Si Herbal Tea

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chung-Ying Lin, PhD; Phone Number: 5106 +886-2353535; Email: cylin36933@gs.ncku.edu.tw

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
World Health Organization Quality of Life Assessment for age (WHOQOL-AGE) [for people with dementia]	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]	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]	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

Outcome Measure	Measure Description	Time Frame
Katz Index of Independence in Activities of Daily Living [for people with dementia]	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]	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]	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]	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]	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]	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]	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]	caregiver burden measure; score range 0-48; higher score indicates greater burden	baseline; 3 months after baseline; 6 months after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comorbidity	Other chronic disease the participants have	baseline

Collaborators and Investigators

• Sponsor: National Cheng Kung University
• Collaborators: Buddhist Tzu Chi General Hospital; E-DA Hospital; Tzu Chi University
• Investigators: Principal Investigator: Hao-Ming Li, MD, Buddhist Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: December 27, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; dementia; quality of life; caregiver; psychosocial health; Jing Si Herbal Tea
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Stress, Psychological; Behavior; Caregiver Burden; Dementia
• Other Study ID 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