DementiaNCT06198699
Effects of Jing Si Herbal Tea on Quality of Life and Sleep in Dementia and Their Caregivers
A study testing Jing Si Herbal Tea in people with Dementia and Caregiver Burden, run by National Cheng Kung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dementia, Caregiver Burden, Quality of Life
- What is being tested?
- Jing Si Herbal Tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jan 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of dementia
- 50 years or older
- with sufficient cognition to complete the questionnaires
- can communicate using Mandarin or Taiwanese
- 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
Who cannot join
- 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:
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tzu-Chi General Hospital
Hualien City
Hao-Ming Li, MD
About this study
Official title: Effects of Jing Si Herbal Tea on Quality of Life and Sleep Among Patients With Dementia and Their Caregivers: A Randomized Controlled 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.
- Conditions
- Dementia, Caregiver Burden, Quality of Life
- Being tested
- Jing Si Herbal Tea
- Keywords
- dementia, caregiver, quality of life, Jing Si Herbal Tea, psychosocial health, randomized controlled trial
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jing Si Herbal TeaDietary supplement
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 group | Role | What they receive |
|---|---|---|
| Jing Si Herbal Tea Group | Experimental | Frequency: Two times of herbal tea (one in the morning; one in the afternoon) per day Duration: Consumption for three months Dosage: One pack (14g) with 600 ml water for each time of herbal tea consumption Receives: Dietary Supplement: Jing Si Herbal Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life Assessment for age (WHOQOL-AGE) [for people with dementia]
quality of life measure; score range 13-65; higher score indicates better quality of life
Measured: baseline; 3 months after baseline; 6 months after baseline
Insomnia Severity Index [for both people with dementia and their caregivers]
sleep problem measure; score range 0-28; higher score indicates more severe insomnia
Measured: baseline; 3 months after baseline; 6 months after baseline
World Health Organization Quality of Life Assessment brief version (WHOQOL-BREF) [for caregivers]
quality of life measure; score range 4-20; higher score indicates better quality of life
Measured: baseline; 3 months after baseline; 6 months after baseline
Secondary outcomes (8)
Katz Index of Independence in Activities of Daily Living [for people with dementia]
activities of daily living function measure; score range 0-6; higher score indicates better activities of daily living
Measured: baseline; 3 months after baseline; 6 months after baseline
5 items of Geriatric Depression Scale [for people with dementia and their caregivers]
depression measure; score range 0-5; higher score indicates greater depression
Measured: baseline; 3 months after baseline; 6 months after baseline
Short Portable Mental Status Questionnaire [for people with dementia]
cognition measure; score range 0-10; higher score indicates poor cognition
Measured: baseline; 3 months after baseline; 6 months after baseline
Clinical Frailty Scale [for people with dementia]
frailty measure; score range 1-9; higher score indicates more frail
Measured: baseline; 3 months after baseline; 6 months after baseline
Integrated care for older people [for people with dementia]
intrinsic capacity measure; score range 0-13; higher score indicates poorer intrinsic capacity
Measured: baseline; 3 months after baseline; 6 months after baseline
Attitude and Thoughts Toward Older People Scale [for people with dementia and their caregivers]
ageism measure; score range 17-85; higher score indicates higher level of ageism
Measured: baseline; 3 months after baseline; 6 months after baseline
Depression, Anxiety, Stress Scale-21 [for people with dementia and their caregivers]
psychological distress measure; score range 0-63; higher score indicates greater distress
Measured: baseline; 3 months after baseline; 6 months after baseline
12 item of Zarit Burden Interview [for caregivers]
caregiver burden measure; score range 0-48; higher score indicates greater burden
Measured: baseline; 3 months after baseline; 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start17 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Collaborators
- Buddhist Tzu Chi General Hospital, Tzu Chi University, E-DA Hospital
- Responsible party
- Principal investigator, Chung-Ying Lin, National Cheng Kung University
- Investigators
- Hao-Ming Li, MD, Principal investigator, Buddhist Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198699
- Sponsor's protocol ID
- TCMF-JCT 113-03
- Status last verified
- Apr 2026
- First submitted
- 27 Dec 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Jing Si Herbal Tea on Quality of Life and Sleep Among Patients With Dementia and Their Caregivers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06198699
- Acronym / sponsor ID
- TCMF-JCT 113-03
- Conditions
- Dementia, Caregiver Burden, Quality of Life
- Keywords
- dementia, caregiver, quality of life, Jing Si Herbal Tea, psychosocial health, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Collaborators
- Buddhist Tzu Chi General Hospital, Tzu Chi University, E-DA Hospital
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jing Si Herbal Tea Group | Experimental | Dietary Supplement: Jing Si Herbal TeaFrequency: Two times of herbal tea (one in the morning; one in the afternoon) per day Duration: Consumption for three months Dosage: One pack (14g) with 600 ml water for each time of herbal tea consumption |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- diagnosis of dementia
- 50 years or older
- with sufficient cognition to complete the questionnaires
- can communicate using Mandarin or Taiwanese
- caregivers of people with dementia for more than half years
Key exclusion criteria (7 listed)
- 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)
- with renal function problems
- not suitable for Jing Si Herbal Tea after evaluation from a psychiatrist/physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jing Si Herbal TeaConsuming Jing Si Herbal Tea for three months; twice per day with each time 14 g of Jing Si Herbal in 600 ml water | Dietary supplement | Jing Si Herbal Tea Group |
Primary outcome
World Health Organization Quality of Life Assessment for age (WHOQOL-AGE) [for people with dementia]
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
Insomnia Severity Index [for both people with dementia and their caregivers]
Time frame: 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]
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
8 secondary outcomes
Katz Index of Independence in Activities of Daily Living [for people with dementia]
Time frame: baseline; 3 months after baseline; 6 months after baseline
5 items of Geriatric Depression Scale [for people with dementia and their caregivers]
Time frame: baseline; 3 months after baseline; 6 months after baseline
Short Portable Mental Status Questionnaire [for people with dementia]
Time frame: baseline; 3 months after baseline; 6 months after baseline
Clinical Frailty Scale [for people with dementia]
Time frame: baseline; 3 months after baseline; 6 months after baseline
Integrated care for older people [for people with dementia]
Time frame: baseline; 3 months after baseline; 6 months after baseline
Attitude and Thoughts Toward Older People Scale [for people with dementia and their caregivers]
Time frame: baseline; 3 months after baseline; 6 months after baseline
Depression, Anxiety, Stress Scale-21 [for people with dementia and their caregivers]
Time frame: baseline; 3 months after baseline; 6 months after baseline
12 item of Zarit Burden Interview [for caregivers]
Time frame: baseline; 3 months after baseline; 6 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hao-Ming Li, MD principal investigator
Buddhist Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jing Si Herbal Tea in people with Dementia and Caregiver Burden, run by National Cheng Kung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chung-Ying Lin, PhD (+886-2353535 ext. 5106, cylin36933@gs.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Quality of Life Assessment for age (WHOQOL-AGE) [for people with dementia] (time frame: baseline; 3 months after baseline; 6 months after baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.