NCT06198699

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

December 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

January 17, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

December 27, 2023

Last Update Submit

April 7, 2026

Conditions

DementiaCaregiver BurdenQuality of Life

Keywords

dementiacaregiverquality of lifeJing Si Herbal Teapsychosocial healthrandomized controlled trial

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (8)

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

    baseline; 3 months after baseline; 6 months after baseline

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

    baseline; 3 months after baseline; 6 months after baseline

  • Short Portable Mental Status Questionnaire [for people with dementia]

    baseline; 3 months after baseline; 6 months after baseline

  • Clinical Frailty Scale [for people with dementia]

    baseline; 3 months after baseline; 6 months after baseline

  • Integrated care for older people [for people with dementia]

    baseline; 3 months after baseline; 6 months after baseline

  • +3 more secondary outcomes

Other Outcomes (1)

  • Comorbidity

    baseline

Study Arms (1)

Jing Si Herbal Tea Group

EXPERIMENTAL

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

Dietary Supplement: Jing Si Herbal Tea

Interventions

Jing Si Herbal TeaDIETARY_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

Jing Si Herbal Tea Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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:
  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tzu-Chi General Hospital

Hualien City, Taiwan

RECRUITING

MeSH Terms

Conditions

DementiaCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Hao-Ming Li, MD

    Buddhist Tzu Chi General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung-Ying Lin, PhD

CONTACT

+886-2353535cylin36933@gs.ncku.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 10, 2024

Study Start

January 17, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)