RecruitingNot ApplicableNCT06198699

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


Sponsor

National Cheng Kung University

Enrollment

400 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 Years

Inclusion Criteria9

  • For people with dementia:
  • diagnosis of dementia
  • 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
  • years or older
  • with sufficient cognition to complete the questionnaires
  • can communicate using Mandarin or Taiwanese

Exclusion Criteria7

  • 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)

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Interventions

DIETARY_SUPPLEMENTJing Si Herbal Tea

Consuming Jing Si Herbal Tea for three months; twice per day with each time 14 g of Jing Si Herbal in 600 ml water


Locations(1)

Tzu-Chi General Hospital

Hualien City, Taiwan

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NCT06198699


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