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NCT Number: NCT06198699

Effects of Jing Si Herbal Tea on Quality of Life and Sleep in Dementia and Their Caregivers

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tzu-Chi General Hospital

Hualien City, Taiwan

Location status: Recruiting

Location contact

Hao-Ming Li, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Jing Si Herbal Tea

Dietary 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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Katz Index of Independence in Activities of Daily Living [for people with dementia]

    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

  2. 5 items of Geriatric Depression Scale [for people with dementia and their caregivers]

    Time frame: baseline; 3 months after baseline; 6 months after baseline

    depression measure; score range 0-5; higher score indicates greater depression

  3. Short Portable Mental Status Questionnaire [for people with dementia]

    Time frame: baseline; 3 months after baseline; 6 months after baseline

    cognition measure; score range 0-10; higher score indicates poor cognition

  4. Clinical Frailty Scale [for people with dementia]

    Time frame: baseline; 3 months after baseline; 6 months after baseline

    frailty measure; score range 1-9; higher score indicates more frail

  5. Integrated care for older people [for people with dementia]

    Time frame: baseline; 3 months after baseline; 6 months after baseline

    intrinsic capacity measure; score range 0-13; higher score indicates poorer intrinsic capacity

  6. 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

    ageism measure; score range 17-85; higher score indicates higher level of ageism

  7. Depression, Anxiety, Stress Scale-21 [for people with dementia and their caregivers]

    Time frame: baseline; 3 months after baseline; 6 months after baseline

    psychological distress measure; score range 0-63; higher score indicates greater distress

  8. 12 item of Zarit Burden Interview [for caregivers]

    Time frame: baseline; 3 months after baseline; 6 months after baseline

    caregiver burden measure; score range 0-48; higher score indicates greater burden

Other outcomes

  1. Comorbidity

    Time frame: baseline

    Other chronic disease the participants have

Study contacts

Contact information is provided by the study sponsor or research team.

Chung-Ying Lin, PhD

CONTACT

[email protected]

+886-2353535 ext. 5106

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Collaborators

  • Buddhist Tzu Chi General Hospital
  • E-DA Hospital
  • Tzu Chi University

Registry information

Official study title

Effects of Jing Si Herbal Tea on Quality of Life and Sleep Among Patients With Dementia and Their Caregivers: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2024
Registry last updated
Apr 13, 2026

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.

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