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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01503346
Other study ID # 100610
Secondary ID Protocol Record
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2011
Est. completion date March 2013

Study information

Verified date February 2020
Source Changhua Christian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Appetite loss is a severe and common symptom among late-stage cancer patients, and it causes great the anxiety for the patient's family. In TCM theory, the investigators call these patients are in block and repulsion condition. The investigators try to set a study to use the herbal medicine solution taken in frequent small amounts by cancer patients in late-stage to improve the appetite loss condition. Through this method, the investigators not only want to improve the quality of life of cancer patients in late-stage but also set a valuable treatment.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date March 2013
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
DaHuang GanTsao Tang
Intervention group 2 grams of DaHuang abstract powder and 0.5 grams GanTsao abstract powder are mixed and separated into four packages; each package was given to each patient four times a day (three time after meal and one time before sleep); each patient received the usual medication of the hospice ward at the same time; 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; 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.

Locations

Country Name City State
Taiwan Changhua Christan Hospital Changhua City Changhua Country

Sponsors (1)

Lead Sponsor Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary appetite score The investigators detect the patients' appetite condition at the 1st,3rd and 6th day. 6 days