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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05454865
Other study ID # IRB110-253-A
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2022

Study information

Verified date December 2021
Source Buddhist Tzu Chi General Hospital
Contact DAH-CHING DING, MD, PhD
Phone 88638561825
Email dah1003@yahoo.com.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cancer-related fatigue caused by cancer and treatment reduces patients' compliance with treatment. Fatigue caused by chemotherapy usually has multifaceted symptoms, such as being very tired, feeling weak, desperate for rest, or decreased activity. Cancer-related fatigue is often the main reason why patients are reluctant to continue treatment. Even after finished chemotherapy, most patients still feel fatigued. Therefore, how to solve the patient's fatigue caused by cancer and treatment is a very important issue, and there is no effective treatment at present. This project plans to use the Jin Si herbal tea developed by our hospital to improve cancer-related fatigue.


Description:

Cancer-related fatigue caused by cancer and treatment reduces patients' compliance with treatment. Fatigue caused by chemotherapy usually has multifaceted symptoms, such as being very tired, feeling weak, desperate for rest, or decreased activity. Cancer-related fatigue is often the main reason why patients are reluctant to continue treatment. Even after finished chemotherapy, most patients still feel fatigued. Therefore, how to solve the patient's fatigue caused by cancer and treatment is a very important issue, and there is no effective treatment at present. This project plans to use the Jin Si herbal tea developed by our hospital to improve cancer-related fatigue. Jin Si Herbal Tea Brief mechanism of action: It contains eight kinds of traditional Chinese medicines, mainly including wormwood, fish needle grass, Ophiopogon japonicas, houttuynia cordata, platycodon, licorice, perilla leaves, and chrysanthemum, which promote lung health including dampness and clean lung heat, diuresis, generate body heat, anti-cold, clean blood, and reduce phlegm.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Patients who received chemotherapy - Patients who understand the experimental process Exclusion Criteria: - Unconscious - Severe disease, not well-controlled patients judged by PI - Pregnancy, breastfeeding, menstruation during screening phase - Weakness, allergy to Herbal tea, frequently felt cold

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Jin Si Herbal Tea
Jin Si Herbal Tea 1 pack PO bid for 2 treatment cycles (1 cycle = 3 weeks)
Placebo
Placebo 1 1pack PO bid for 1 treatment cycle (1 cycle = 3 weeks) and followed by Jin Si Herbal Tea 1 pack PO bid for the 2nd treatment cycle

Locations

Country Name City State
Taiwan Hualien Tzu Chi Hospital Hualien City Please Select

Sponsors (1)

Lead Sponsor Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brief Fatigue Inventory-Taiwanese (BFI-T) scores 0-90, higher scores mean the worse outcome 2 months
Primary Functional Assessment of Cancer Therapy-General (FACT-G7, Version 4) scores 0-28, higher scores mean the worse outcome 2 months
Secondary Laboratory assessment (White Blood Cells count, Differential count) monitor bone marrow function 2 months
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