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

National Cheng Kung University

Status: Not yet enrolling

Conditions: Quality of Life; Caregiver Burden; Dementia

Treatments: Dietary Supplement: Barley Tea; Dietary Supplement: Jing Si Herbal Tea

Study type: Interventional

Funder types: Other

Identifiers

NCT06198699

TCMF-JCT 113-03

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

Jing Si Herbal Tea Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Jing Si Herbal Tea

Barley Tea Group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Barley Tea