Jing Si Herbal Tea for improving quality of life and sleep in people with dementia and their caregivers
Effects of Jing Si Herbal Tea on Quality of Life and Sleep Among Patients With Dementia and Their Caregivers: A Randomized Controlled Trial
This project will test whether taking Jing Si Herbal Tea twice daily can help improve quality of life and sleep for people with dementia and their family caregivers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Cheng Kung University Academic / other |
| Locations | 1 site (Hualien City) |
| Trial ID | NCT06198699 on ClinicalTrials.gov |
What this trial studies
This three-year interventional project will first examine the feasibility of daily Jing Si Herbal Tea use in people with dementia and then measure effects on quality of life and psychosocial health for both patients and their caregivers. In year one, 100 people with dementia will be asked to take the tea twice a day while researchers track adherence and safety. Outcomes will include standardized quality-of-life and sleep questionnaires for patients and validated measures of caregiver burden and psychosocial well-being. The protocol excludes people with renal problems or those deemed unsuitable by a clinician, and data collection will occur at participating hospital sites.
Who should consider this trial
Good fit: Ideal participants are people aged 50 or older with a diagnosis of dementia who can complete questionnaires and speak Mandarin or Taiwanese, along with their caregivers aged 20 or older who have provided care for more than six months.
Not a fit: Patients with renal dysfunction, those judged unsuitable for the herbal tea by a psychiatrist or physician, or those with insufficient cognition to participate are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, regular use of Jing Si Herbal Tea could improve sleep, quality of life, and psychosocial well-being for people with dementia and reduce caregiver burden.
How similar studies have performed: Some animal studies and clinical reports have suggested benefits of Jing Si Herbal Tea for conditions like aging, depression, and sleep, but its effects specifically in dementia patients and their caregivers remain largely untested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Hualien City
- Tzu-Chi General Hospital — Hualien City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Hao-Ming Li, MD — Buddhist Tzu Chi General Hospital
- Study coordinator: Chung-Ying Lin, PhD
- Email: cylin36933@gs.ncku.edu.tw
- Phone: +886-2353535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.