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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06141902
Other study ID # IRB111-125-A
Secondary ID IMAR-111-01-17
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source Buddhist Tzu Chi General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aim to explore the impact of Jing Si Herbal Tea on pain and emotional stress in peripheral blood stem cell donors.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 55 Years
Eligibility Inclusion Criteria: - health Men or women aged 20 to 55 years old - willing to take Jing Si Herbal Drink Exclusion Criteria: - no willing to take Jing Si Herbal Drink; - Previously already take Jing Si Herbal Drink daily

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Jing Si Herbal Drink
Jing Si Herbal Drink

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Buddhist Tzu Chi General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in pain assessed by questionnaires For each of the pain sites includes: headache?bone?joint & muscle, indicate the severity of present using the following scale (baseline vs. follow-up).
grade 0: fully active, able to carry on all pre-disease performance without restriction
grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work
grade 2: ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours
grade 3: capable of only limited self-care, confined to bed or chair more than 50% of waking hours
grade 4: completely disabled, cannot carry on any self-care, totally confined to bed or chair
grade 5: dead
5 day
Secondary Changes in anxiety assessed by questionnaires Difference in donor Health State Trait Anxiety Index (STAI) scores (baseline vs. follow-up).
The STAI questionnaire consists of 20 items for assessing "state anxiety" and 20 items for assessing "trait anxiety," with a raw score of 20 to 60 points for each scale.
The state anxiety scale evaluates the current state of anxiety associated with a special situation, measuring subjective feelings of apprehension, tension, nervousness, worry, and activation of the autonomic nervous system, whereas the trait anxiety scale evaluates proneness to anxiety .
The level of anxiety was determined according to the percentile rank obtained using the raw score of each questionnaire and was classified as low anxiety (1st-23th percentile), moderate anxiety (25th75th percentile) and high anxiety (77th-99th percentile).
21 days
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