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

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

Treatments tested in this trial

  • Jing Si Herbal Tea

Treatment groups

400 Participants
are divided into 1 treatment group

Sponsors and collaborators

National Cheng Kung University

Lead sponsor

Buddhist Tzu Chi General Hospital

Collaborator

Tzu Chi University

Collaborator

E-DA Hospital

Collaborator