DaHuang GangTsao Tang to Improve the Appetite Loss Condition of Cancer Patients

NCT ID: NCT01503346

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-03-31

Brief 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.

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.

Conditions

Non-organic Loss of Appetite

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

herbal medicine

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.

Group Type: EXPERIMENTAL

DaHuang GanTsao Tang

Intervention Type: DRUG

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.

Interventions

DaHuang GanTsao Tang

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.

Intervention Type: DRUG

Other Intervention Names

Herbal Medicine Group

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhua Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu De LIU, Master

Role: STUDY_CHAIR

Changhua Christian Hospital

Locations

Changhua Christan Hospital

Changhua, Changhua Country, Taiwan

Countries

Taiwan

Other Identifiers

Protocol Record 100610

Identifier Type: REGISTRY

Identifier Source: secondary_id

100610

Identifier Type: -

Identifier Source: org_study_id