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

NCT06198699 — Not applicable, Recruiting, 400 participants, National Cheng Kung University

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

Registry	NCT06198699
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	400 (Estimated)
Sponsor	National Cheng Kung University (Other); collaborators: Buddhist Tzu Chi General Hospital, Tzu Chi University, E-DA Hospital
Conditions	Dementia, Caregiver Burden, Quality of Life
Interventions	Jing Si Herbal Tea (Dietary supplement)
Dates	start 2025-01-17, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2024-01-10, last updated 2026-04-13
Locations	1 site in Taiwan

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Jing Si Herbal Tea Group	Experimental	Dietary Supplement: Jing Si Herbal Tea	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

Jing Si Herbal Tea (Dietary supplement): Consuming Jing Si Herbal Tea for three months; twice per day with each time 14 g of Jing Si Herbal in 600 ml water

+Outcome measures

Primary outcomes

World Health Organization Quality of Life Assessment for age (WHOQOL-AGE) [for people with dementia] [baseline; 3 months after baseline; 6 months after baseline]: quality of life measure; score range 13-65; higher score indicates better quality of life
Insomnia Severity Index [for both people with dementia and their caregivers] [baseline; 3 months after baseline; 6 months after baseline]: sleep problem measure; score range 0-28; higher score indicates more severe insomnia
World Health Organization Quality of Life Assessment brief version (WHOQOL-BREF) [for caregivers] [baseline; 3 months after baseline; 6 months after baseline]: quality of life measure; score range 4-20; higher score indicates better quality of life

Secondary outcomes

Katz Index of Independence in Activities of Daily Living [for people with dementia] [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
5 items of Geriatric Depression Scale [for people with dementia and their caregivers] [baseline; 3 months after baseline; 6 months after baseline]: depression measure; score range 0-5; higher score indicates greater depression
Short Portable Mental Status Questionnaire [for people with dementia] [baseline; 3 months after baseline; 6 months after baseline]: cognition measure; score range 0-10; higher score indicates poor cognition
Clinical Frailty Scale [for people with dementia] [baseline; 3 months after baseline; 6 months after baseline]: frailty measure; score range 1-9; higher score indicates more frail
Integrated care for older people [for people with dementia] [baseline; 3 months after baseline; 6 months after baseline]: intrinsic capacity measure; score range 0-13; higher score indicates poorer intrinsic capacity
Attitude and Thoughts Toward Older People Scale [for people with dementia and their caregivers] [baseline; 3 months after baseline; 6 months after baseline]: ageism measure; score range 17-85; higher score indicates higher level of ageism
Depression, Anxiety, Stress Scale-21 [for people with dementia and their caregivers] [baseline; 3 months after baseline; 6 months after baseline]: psychological distress measure; score range 0-63; higher score indicates greater distress
12 item of Zarit Burden Interview [for caregivers] [baseline; 3 months after baseline; 6 months after baseline]: caregiver burden measure; score range 0-48; higher score indicates greater burden

Other outcomes

Comorbidity [baseline]: Other chronic disease the participants have

+Eligibility

Sex: All, ages: 20 Years to any

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)

+Locations (1)

Facility	City	Country	Status
Tzu-Chi General Hospital	Hualien City	Taiwan	Recruiting

+Investigators

Hao-Ming Li, MD, Principal investigator, Buddhist Tzu Chi General Hospital