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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Yu-De Liu, Changhua Christian Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01503346
First Posted: January 4, 2012
Last Update Posted: January 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Changhua Christian Hospital
Information provided by (Responsible Party):
Yu-De Liu, Changhua Christian Hospital
  Purpose
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.

Condition Intervention Phase
Non-organic Loss of Appetite Drug: DaHuang GanTsao Tang Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Yu-De Liu, Changhua Christian Hospital:

Primary Outcome Measures:
  • appetite score [ Time Frame: 6 days ]
    The investigators detect the patients' appetite condition at the 1st,3rd and 6th day.


Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: March 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: 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.
Other Name: Herbal Medicine Group

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503346


Contacts
Contact: Y D LIU, Master 886-988-285196 lude961031@gmail.com
Contact: S C YANG, Master 886-937-251181 a884215@gmailc.om

Locations
Taiwan
Changhua Christan Hospital Recruiting
Changhua City, Changhua Country, Taiwan, 500
Contact: Y D LIU, Master    886-988-285196    lude961031@gmail.com   
Contact: S C YANG, Master    886-937-251181    a884215@gmail.com   
Sponsors and Collaborators
Yu-De Liu
Changhua Christian Hospital
Investigators
Study Chair: Yu De LIU, Master Changhua Christian Hospital
  More Information

Responsible Party: Yu-De Liu, Principal Investigator, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT01503346     History of Changes
Other Study ID Numbers: 100610
Protocol Record 100610 ( Registry Identifier: YDLiu )
First Submitted: November 7, 2011
First Posted: January 4, 2012
Last Update Posted: January 4, 2012
Last Verified: January 2012

Keywords provided by Yu-De Liu, Changhua Christian Hospital:
Appetite Loss

Additional relevant MeSH terms:
Anorexia
Signs and Symptoms, Digestive
Signs and Symptoms