NCT06198699 Effects of Jing Si Herbal Tea on Quality of Life and Sleep in Dementia and Their Caregivers
| NCT ID | NCT06198699 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cheng Kung University |
| Condition | Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-01-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-01-17 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Hao-Ming Li, MD
PRINCIPAL INVESTIGATOR
Buddhist Tzu Chi General Hospital
Frequently Asked Questions
Who can join the NCT06198699 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06198699 currently recruiting?
Yes, NCT06198699 is actively recruiting participants. Contact the research team at cylin36933@gs.ncku.edu.tw for enrollment information.
Where is the NCT06198699 trial being conducted?
This trial is being conducted at Hualien City, Taiwan.
Who is sponsoring the NCT06198699 clinical trial?
NCT06198699 is sponsored by National Cheng Kung University. The principal investigator is Hao-Ming Li, MD at Buddhist Tzu Chi General Hospital. The trial plans to enroll 400 participants.