The Effects of Jing Si Herbal Tea on Physical and Psychological Symptoms in Peripheral Blood Hematopoietic Stem Cell Donors

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

Official Title
-----------------
The Effects of Jing Si Herbal Tea on Physical and Psychological Symptoms in Peripheral Blood Hematopoietic Stem Cell Donors

Conditions
-----------------
Pain Syndrome, Emotional Stress

Intervention / Treatment
-----------------
* Other: Jing Si Herbal Drink


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NORMAL<br>daily diet | Other: Jing Si Herbal Drink<br>* Jing Si Herbal Drink<br>|
| No Intervention: Take Jing Si Herbal Drink<br>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 | 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 | 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 |