Tzu-Chi General Hospital
Hualien City, Taiwan
Location status: Recruiting
Location contact
Hao-Ming Li, MD
CONTACT
NCT Number: NCT06198699
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.
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Not applicable
Hualien City, Taiwan
Location status: Recruiting
Hao-Ming Li, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
For people with dementia:
Inclusion criteria
Exclusion criteria
For caregivers:
Inclusion criteria
Exclusion criteria
Consuming Jing Si Herbal Tea for three months; twice per day with each time 14 g of Jing Si Herbal in 600 ml water
Time frame: baseline; 3 months after baseline; 6 months after baseline
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
sleep problem measure; score range 0-28; higher score indicates more severe insomnia
Time frame: baseline; 3 months after baseline; 6 months after baseline
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
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
depression measure; score range 0-5; higher score indicates greater depression
Time frame: baseline; 3 months after baseline; 6 months after baseline
cognition measure; score range 0-10; higher score indicates poor cognition
Time frame: baseline; 3 months after baseline; 6 months after baseline
frailty measure; score range 1-9; higher score indicates more frail
Time frame: baseline; 3 months after baseline; 6 months after baseline
intrinsic capacity measure; score range 0-13; higher score indicates poorer intrinsic capacity
Time frame: baseline; 3 months after baseline; 6 months after baseline
ageism measure; score range 17-85; higher score indicates higher level of ageism
Time frame: baseline; 3 months after baseline; 6 months after baseline
psychological distress measure; score range 0-63; higher score indicates greater distress
Time frame: baseline; 3 months after baseline; 6 months after baseline
caregiver burden measure; score range 0-48; higher score indicates greater burden
Time frame: baseline
Other chronic disease the participants have
Contact information is provided by the study sponsor or research team.
National Cheng Kung University
Other
Effects of Jing Si Herbal Tea on Quality of Life and Sleep Among Patients With Dementia and Their Caregivers: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05352529
Activities of Daily Living, Alzheimer Disease
Atlanta, Georgia, United States
View Trial DetailsNCT06584110
Behavior, Behavioral Symptoms
Hong Kong
View Trial DetailsNCT06418971
Behavior, Behavioral Symptoms
Los Angeles, California, United States
View Trial DetailsNCT06168604
Alzheimer Disease, Behavior
New York, United States
View Trial Details