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

Primary Purpose

Non-organic Loss of Appetite

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
DaHuang GanTsao Tang
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-organic Loss of Appetite focused on measuring Appetite Loss

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Changhua Christan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

herbal medicine

Arm 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.

Outcomes

Primary Outcome Measures

appetite score
The investigators detect the patients' appetite condition at the 1st,3rd and 6th day.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2011
Last Updated
February 13, 2020
Sponsor
Changhua Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01503346
Brief Title
DaHuang GangTsao Tang to Improve the Appetite Loss Condition of Cancer Patients
Acronym
TCM
Official Title
Taking Herbal Formula:DaHuang GangTsao Tang to Improve the Appetite Loss Condition of Cancer Patients in Late-stage:A Clinical Control Trial Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changhua Christian Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-organic Loss of Appetite
Keywords
Appetite Loss

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
herbal medicine
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
DaHuang GanTsao Tang
Other Intervention Name(s)
Herbal Medicine Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
appetite score
Description
The investigators detect the patients' appetite condition at the 1st,3rd and 6th day.
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu De LIU, Master
Organizational Affiliation
Changhua Christian Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Changhua Christan Hospital
City
Changhua City
State/Province
Changhua Country
ZIP/Postal Code
500
Country
Taiwan

12. IPD Sharing Statement

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

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