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

Sponsor
Changhua Christian Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01580358
Collaborator
Committee on Chinese Medicine and Pharmacy (Other)
60
Enrollment
1
Location
2
Arms
35
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Changhua Christian Hospital
Study Start Date :
Oct 1, 2009
Anticipated Primary Completion Date :
Jun 1, 2012
Anticipated Study Completion Date :
Sep 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in EORTC QOL-C30 at four weeks [baseline and four weeks]

Secondary Outcome Measures

  1. Change from baseline in BUN, Creatinine, GOT, GPT at four weeks [baseline and four weeks]

    monitor the liver function and renal function

  2. Change from baseline in Heart rate variability at four weeks [baseline and four weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Changhua Christian Hospital Changhua Taiwan

Sponsors and Collaborators

  • Changhua Christian Hospital
  • Committee on Chinese Medicine and Pharmacy

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chia-Yun Chen, MD, Changhua Christian Hospital
ClinicalTrials.gov Identifier:
NCT01580358
Other Study ID Numbers:
  • CCMP98 -CT-203
First Posted:
Apr 19, 2012
Last Update Posted:
Jun 21, 2012
Last Verified:
Jun 1, 2012
Keywords provided by Chia-Yun Chen, MD, Changhua Christian Hospital
cancer
radiotherapy
chemotherapy
Traditional Chinese Medicine
Safety

Study Results

No Results Posted as of Jun 21, 2012