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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-09-30

Brief Summary

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

Detailed Description

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

Conditions

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Cancer Patients Undergoing Chemotherapy or Radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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).

Group Type ACTIVE_COMPARATOR

Shen-Mai San

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Starch

Intervention Type DRUG

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).

Intervention Type DRUG

Starch

It was packed in granules with 0.5gm starch. Patients took eight granules three times per day for four weeks.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Committee on Chinese Medicine and Pharmacy

OTHER_GOV

Sponsor Role collaborator

Changhua Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chia-Yun Chen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chia Yun Chen, MD

Role: CONTACT

+886-47238595 ext. 4027

Facility Contacts

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Chia Yun Chen, MD

Role: primary

+886-47238595 ext. 4027

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.

Reference Type DERIVED
PMID: 23206440 (View on PubMed)

Other Identifiers

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CCMP98 -CT-203

Identifier Type: -

Identifier Source: org_study_id

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