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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

More National Cheng Kung University trials in Taiwan

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