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Therapeutic Effects of Traditional Chinese Medicine, Shen-Mai San in Cancer Patient Undergoing Chemotherapy or Radiotherapy

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 June 2012 by Chia-Yun Chen, Changhua Christian Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01580358
First Posted: April 19, 2012
Last Update Posted: June 21, 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:
Committee on Chinese Medicine and Pharmacy
Information provided by (Responsible Party):
Chia-Yun Chen, Changhua Christian Hospital
  Purpose
Using Shen-Mai-San for cancer patients undergoing chemotherapy or radiotherapy could help these people improve the quality of life.

Condition Intervention
Cancer Patients Undergoing Chemotherapy or Radiotherapy Drug: Shen-Mai San Drug: Starch

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Changhua Christian Hospital

Resource links provided by NLM:


Further study details as provided by Chia-Yun Chen, Changhua Christian Hospital:

Primary Outcome Measures:
  • Change from baseline in EORTC QOL-C30 at four weeks [ Time Frame: baseline and four weeks ]

Secondary Outcome Measures:
  • Change from baseline in BUN, Creatinine, GOT, GPT at four weeks [ Time Frame: baseline and four weeks ]
    monitor the liver function and renal function

  • Change from baseline in Heart rate variability at four weeks [ Time Frame: baseline and four weeks ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Shen-Mai San
Shen mai san is composed of three herb medicines, Ginseng radis, Liriope spicata, and Schizandrae fructus and was manufactured into concentrated herbal extract and packed with 0.5g per capsule and labeled by Sun-Ten pharmaceutical company in Taiwan with good manufacturing practice (GMP).
Drug: Shen-Mai San
Shen mai san is composed of three herb medicines, Ginseng radis, Liriope spicata, and Schizandrae fructus and was manufactured into concentrated herbal extract and packed with 0.5g per capsule and labeled by Sun-Ten pharmaceutical company in Taiwan with good manufacturing practice (GMP).
Placebo Comparator: starch
Starch in the same granule as intervention group for this double-blind trial
Drug: Starch
It was packed in granules with 0.5gm starch. Patients took eight granules three times per day for four weeks.

Detailed Description:
Shen-Mai-San could improve fatigue, general weakness, neutropenia for patients under going chemotherapy or radiotherapy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postoperative patients with histologically confirmed cancer within 3 years and undergoing chemotherapy or radiotherapy
  • age above 18 years old
  • signed informed consent
  • ability to read Chinese, ability for oral intake.

Exclusion Criteria:

  • being pregnancy
  • on breast feeding
  • completed chemotherapy or radiotherapy
  • brain metastasis with Eastern Cooperative Oncology Group (ECOG) performance status of two to four
  • delusion or hallucination
  • acute infection
  • received medications for other clinical trials.
  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): NCT01580358


Contacts
Contact: Chia Yun Chen, MD +886-47238595 ext 4027 137877@cch.org.tw

Locations
Taiwan
Changhua Christian Hospital Recruiting
Changhua, Taiwan
Contact: Chia Yun Chen, MD    +886-47238595 ext 4027    137877@cch.org.tw   
Principal Investigator: Lun Chien Lo, MD.PhD         
Sponsors and Collaborators
Changhua Christian Hospital
Committee on Chinese Medicine and Pharmacy
Investigators
Principal Investigator: Lun Chien Lo, MD. PhD Changhua Christian Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chia-Yun Chen, MD, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT01580358     History of Changes
Other Study ID Numbers: CCMP98 -CT-203
First Submitted: April 16, 2012
First Posted: April 19, 2012
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by Chia-Yun Chen, Changhua Christian Hospital:
cancer
radiotherapy
chemotherapy
Traditional Chinese Medicine
Safety