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

NCT ID: NCT06198699

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Dementia; Caregiver Burden; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Jing Si Herbal Tea Group

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

Group Type: EXPERIMENTAL

Jing Si Herbal Tea

Intervention Type: 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

Barley Tea Group

Frequency: Two times of barley tea (one in the morning; one in the afternoon) per day Duration: Consumption for three months Dosage: 600 ml each time of barley tea consumption

Group Type: PLACEBO_COMPARATOR

Barley Tea

Intervention Type: DIETARY_SUPPLEMENT

Consuming Barley Tea for three months; twice per day with each time 600 ml barley tea consumption

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Barley Tea

Consuming Barley Tea for three months; twice per day with each time 600 ml barley tea consumption

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

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:

• 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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role: collaborator

Tzu Chi University

OTHER

Sponsor Role: collaborator

E-DA Hospital

OTHER

Sponsor Role: collaborator

National Cheng Kung University

OTHER

Sponsor Role: lead

Responsible Party

Chung-Ying Lin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Chung-Ying Lin, PhD

Role: CONTACT

cylin36933@gs.ncku.edu.tw

+886-2353535 ext. 5106

Other Identifiers

TCMF-JCT 113-03

Identifier Type: -

Identifier Source: org_study_id