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

Sponsored by National Cheng Kung University

About this trial

Last updated 2 years ago

Study ID

TCMF-JCT 113-03

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

20+ Years
All Sexes

Trial Timing

Started 2 years ago

What is this trial about?

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.

What are the Participation Requirements?

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)