Therapeutic Effects of Traditional Chinese Medicine, Shen-Mai San in Cancer Patient Undergoing Chemotherapy or Radiotherapy
NCT ID: NCT01580358
Last Updated: 2012-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2009-10-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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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).
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).
starch
Starch in the same granule as intervention group for this double-blind trial
Starch
It was packed in granules with 0.5gm starch. Patients took eight granules three times per day for four weeks.
Interventions
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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).
Starch
It was packed in granules with 0.5gm starch. Patients took eight granules three times per day for four weeks.
Eligibility Criteria
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Inclusion Criteria
* age above 18 years old
* signed informed consent
* ability to read Chinese, ability for oral intake.
Exclusion Criteria
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Committee on Chinese Medicine and Pharmacy
OTHER_GOV
Changhua Christian Hospital
OTHER
Responsible Party
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Chia-Yun Chen
MD
Principal Investigators
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Lun Chien Lo, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Changhua Christian Hospital
Locations
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Changhua Christian Hospital
Changhua, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Lo LC, Chen CY, Chen ST, Chen HC, Lee TC, Chang CS. Therapeutic efficacy of traditional Chinese medicine, Shen-Mai San, in cancer patients undergoing chemotherapy or radiotherapy: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2012 Dec 3;13:232. doi: 10.1186/1745-6215-13-232.
Other Identifiers
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CCMP98 -CT-203
Identifier Type: -
Identifier Source: org_study_id
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