- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01503346
DaHuang GangTsao Tang to Improve the Appetite Loss Condition of Cancer Patients (TCM)
Taking Herbal Formula:DaHuang GangTsao Tang to Improve the Appetite Loss Condition of Cancer Patients in Late-stage:A Clinical Control Trial Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Intervention group
- 1. 2 grams of DaHuang abstract powder and 0.5 grams GanTsao abstract powder are mixed and separated into four packages;
- 2. each package was given to each patient four times a day (three time after meal and one time before sleep);
- 3. each patient received the usual medication of the hospice ward at the same time;
- 4. record the patients' score of pre-test, mid-test and after-test of QIPCTP at the 1st day, the 3rd day and the 6th day;
- 5. record the patients' score of EORTC QLQ-C30 V3.0 and ECOG (Eastern Cooperative Oncology Group Performance Status) at the 1st day and the 6th day.
Control group
- 1. each patient received the usual medication of the hospice ward during the trial interval;
- 2. record the patients' score of receive pre-test, mid-test and after-test of QIPCTP at the 1st day, the 3rd day and the 6th day;
- 3. record the patients' score of EORTC QLQ-C30 V3.0 and ECOG (Eastern Cooperative Oncology Group Performance Status) at at the 1st day and the 6th day.
Medicine DaHuang herbal abstract powder is produced by Sun Ten Pharmaceutical Co., Ltd, and it's product serial number: 276001. GanCao herbal abstract powder is also produced by Sun Ten Pharmaceutical Co., Ltd, and it's product serial number: 185645. Each herbal abstract powder is qualified with the data of HPLC to confirm each content and stability. The pharmaceutical company is qualified by Good Manufacturing Practice (GMP) certification in Taiwan.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Changhua Country
-
Changhua City, Changhua Country, Taiwan, 500
- Changhua Christan Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Terminal cancer patients in hospice ward
- Patients with appetite loss condition
- Ages between 20 to 80 years old
- No history of diabetes
Exclusion Criteria:
- Entered the stage of dying patients
- Receiving other traditional Chinese medicine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: herbal medicine
Intervention group
|
Intervention group
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
appetite score
Time Frame: 6 days
|
The investigators detect the patients' appetite condition at the 1st,3rd and 6th day.
|
6 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Yu De LIU, Master, Changhua Christian Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100610
- Protocol Record 100610 (Registry Identifier: YDLiu)
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