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

This study is currently recruiting participants.
Verified January 2012 by Changhua Christian Hospital
Sponsor:
Collaborator:
Changhua Christian Hospital
Information provided by (Responsible Party):
Yu-De Liu, Changhua Christian Hospital
ClinicalTrials.gov Identifier:
NCT01503346
First received: November 7, 2011
Last updated: January 3, 2012
Last verified: January 2012
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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:

U.S. FDA Resources

Further study details as provided by Changhua Christian Hospital:

Primary Outcome Measures:
  • appetite score [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 7, 2011
Last Updated: January 3, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Changhua Christian Hospital:
Appetite Loss

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

ClinicalTrials.gov processed this record on June 17, 2013