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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06198699
• Other study ID #: TCMF-JCT 113-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: National Cheng Kung University
• Contact: Chung-Ying Lin, PhD
• Phone: +886-2353535
• Email: cylin36933[@]gs.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Caregiver Burden
• Dementia
• Quality of Life

Intervention

Dietary Supplement:
• Jing 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
• Barley Tea
Consuming Barley Tea for three months; twice per day with each time 600 ml barley tea consumption

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
National Cheng Kung University	Buddhist Tzu Chi General Hospital, E-DA Hospital, Tzu Chi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comorbidity	Other chronic disease the participants have	baseline
Primary	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	baseline; 3 months after baseline; 6 months after baseline
Primary	Insomnia Severity Index [for both people with dementia and their caregivers]	sleep problem measure; score range 0-28; higher score indicates more severe insomnia	baseline; 3 months after baseline; 6 months after baseline
Primary	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	baseline; 3 months after baseline; 6 months after baseline
Secondary	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	baseline; 3 months after baseline; 6 months after baseline
Secondary	5 items of Geriatric Depression Scale [for people with dementia and their caregivers]	depression measure; score range 0-5; higher score indicates greater depression	baseline; 3 months after baseline; 6 months after baseline
Secondary	Short Portable Mental Status Questionnaire [for people with dementia]	cognition measure; score range 0-10; higher score indicates poor cognition	baseline; 3 months after baseline; 6 months after baseline
Secondary	Clinical Frailty Scale [for people with dementia]	frailty measure; score range 1-9; higher score indicates more frail	baseline; 3 months after baseline; 6 months after baseline
Secondary	Integrated care for older people [for people with dementia]	intrinsic capacity measure; score range 0-13; higher score indicates poorer intrinsic capacity	baseline; 3 months after baseline; 6 months after baseline
Secondary	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	baseline; 3 months after baseline; 6 months after baseline
Secondary	Depression, Anxiety, Stress Scale-21 [for people with dementia and their caregivers]	psychological distress measure; score range 0-63; higher score indicates greater distress	baseline; 3 months after baseline; 6 months after baseline
Secondary	12 item of Zarit Burden Interview [for caregivers]	caregiver burden measure; score range 0-48; higher score indicates greater burden	baseline; 3 months after baseline; 6 months after baseline