- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06141902
The Effects of Jing Si Herbal Tea on Physical and Psychological Symptoms in Peripheral Blood Hematopoietic Stem Cell Donors
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hualien City, Taiwan, 970
- Hualiien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: NORMAL
daily diet
|
Jing Si Herbal Drink
|
|
No Intervention: Take Jing Si Herbal Drink
Take Jing Si Herbal Drink daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in pain assessed by questionnaires
Time Frame: 5 day
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in anxiety assessed by questionnaires
Time Frame: 21 days
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB111-125-A
- IMAR-111-01-17 (Other Grant/Funding Number: BuddhistTCGH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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