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

Changhua Christian Hospital

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01580358

Enrollment

Registered

2012-04-19

Start date

2009-10-31

Completion date

2012-09-30

Last updated

2012-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Patients Undergoing Chemotherapy or Radiotherapy

Keywords

cancer, radiotherapy, chemotherapy, Traditional Chinese Medicine, Safety

Brief summary

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

Detailed description

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

Interventions

DRUGShen-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).

DRUGStarch

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in EORTC QOL-C30 at four weeks	baseline and four weeks

Secondary

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

Countries

Taiwan

Contacts

Primary ContactChia Yun Chen, MD

137877@cch.org.tw+886-47238595

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026