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

June 19, 2012 updated by: Chia-Yun Chen, Changhua Christian Hospital

Changhua Christian Hospital

Using Shen-Mai-San for cancer patients undergoing chemotherapy or radiotherapy could help these people improve the quality of life.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Changhua, Taiwan
        • Recruiting
        • Changhua Christian Hospital
        • Contact:
        • Principal Investigator:
          • Lun Chien Lo, MD.PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in EORTC QOL-C30 at four weeks
Time Frame: baseline and four weeks
baseline and four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in BUN, Creatinine, GOT, GPT at four weeks
Time Frame: baseline and four weeks
monitor the liver function and renal function
baseline and four weeks
Change from baseline in Heart rate variability at four weeks
Time Frame: baseline and four weeks
baseline and four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhua Christian Hospital

Collaborators

Committee on Chinese Medicine and Pharmacy

Investigators

  • Principal Investigator: Lun Chien Lo, MD. PhD, Changhua Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

April 17, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Estimate)

June 21, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CCMP98 -CT-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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