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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Cheng Kung University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosis of dementia

50 years or older

with sufficient cognition to complete the questionnaires

can communicate using Mandarin or Taiwanese

Disqualifiers

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)

caregivers of people with dementia for more than half years

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Jing Si Herbal Tea GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
baseline; 3 months after baseline; 6 months after baseline
2

Insomnia Severity Index [for both people with dementia and their caregivers]

sleep problem measure; score range 0-28; higher score indicates more severe insomnia

Time frame
baseline; 3 months after baseline; 6 months after baseline
3

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

Time frame
baseline; 3 months after baseline; 6 months after baseline

Secondary outcomes

1

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

Time frame
baseline; 3 months after baseline; 6 months after baseline
2

5 items of Geriatric Depression Scale [for people with dementia and their caregivers]

depression measure; score range 0-5; higher score indicates greater depression

Time frame
baseline; 3 months after baseline; 6 months after baseline
3

Short Portable Mental Status Questionnaire [for people with dementia]

cognition measure; score range 0-10; higher score indicates poor cognition

Time frame
baseline; 3 months after baseline; 6 months after baseline
4

Clinical Frailty Scale [for people with dementia]

frailty measure; score range 1-9; higher score indicates more frail

Time frame
baseline; 3 months after baseline; 6 months after baseline

Other outcomes

1

Comorbidity

Other chronic disease the participants have

Time frame
baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cheng Kung University

Lead sponsor

Buddhist Tzu Chi General Hospital

Collaborator

Tzu Chi University

Collaborator

E-DA Hospital

Collaborator