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| Sponsors and Collaborators: |
Chinese University of Hong Kong Prince of Wales Hospital, Hong Kong Queen Elizabeth Hospital, Hong Kong Princess Margaret Hospital, Hong Kong |
|---|---|
| Information provided by: | Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00575926 |
Purpose
Ganoderma lucidum (Lingzhi) is a Traditional Chinese Medicine which is widely used as a means to 'strengthen immunity' among patients with cancers. However, there is no published randomized controlled clinical trial on its efficacy and safety despite the many in vitro studies on its anti-viral, anti-oxidative, anti-tumour, radioprotective, hepato-protective and immunomodulatory effects. This study was a randomized, double-blind, placebo-controlled, parallel clinical trial that investigated the benefits and safety of Ganoderma lucidum (Lingzhi) in treating children with cancers. Patients were randomized to receive identical capsules of either Lingzhi or placebo for six months. The primary outcome was the general Paediatric Quality of Life score.
Secondary outcomes included immune functions, infection-related morbidities, complete blood counts and serum biochemistry, and overall and event-free survival.
| Condition | Intervention | Phase |
|---|---|---|
|
Pediatric Cancers |
Drug: LingZhi capsule |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of the Clinical Effects of Ganoderma Lucidum (Ling Zhi) in Children With Cancer |
| Enrollment: | 58 |
| Study Start Date: | September 2002 |
| Study Completion Date: | September 2007 |
| Arms | Assigned Interventions |
|---|---|
|
A: Lingzhi extract: Active Comparator
Oral 300mg capsules containing Lingzhi extract (4 to 6 capsules per day as dosed by patients' age)
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Drug: LingZhi capsule
LingZhi or Placebo 300 mg x 4 or 300 mg x 6 capsules daily according to age group
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B: Placebo: Placebo Comparator
Starch with same appearance and taste as LingZhi
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Drug: LingZhi capsule
LingZhi or Placebo 300 mg x 4 or 300 mg x 6 capsules daily according to age group
|
Alternative and complementary medicine are widely used in treating children with cancers. A population-based survey in British Columbia revealed that they were used by 42% of the respondents. Among Chinese in Hong Kong, Traditional Chinese Medicine (TCM) is also widely practiced. Some 60% of the population had consulted TCM practitioners at one time or another. TCM use could be dated back to more than five thousand years ago, and written records were available for over two thousand years. TCM is considered to be an integral part of the Chinese culture. In our experience, TCM is believed to be commonly used to 'strengthen immunity and promote health' among local children with cancers, despite the lack of well-designed study to prove its usefulness.
Ganoderma lucidum (Ling Zhi) is a mushroom long-used in China for a broad range of disorders. Its use is common in the general population and among both adults and children with a wide range of malignancies. However, there is no randomized controlled trial to support its clinical efficacy and safety. Therefore, we conducted this clinical trial of Ganoderma lucidum (Ling Zhi) among Hong Kong children with cancers.
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Hong Kong | |
| Department of Pediatrics, The Chinese University of Hong Kong | |
| Hong Kong, Hong Kong | |
| Department of Pediatrics, Queen Elizabeth Hospital | |
| Hong Kong, Hong Kong | |
| Department of Pediatrics and Adolescent Medicine, Princess Margaret Hospital | |
| Hong Kong, Hong Kong | |
| Principal Investigator: | Matthew MK Shing, MBBS, FRCP | Department of Pediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong |
More Information
| Responsible Party: | Department of Pediatrics, Prince of Wales Hospital, Shatin, Hong Kong ( Dr. Matthew Ming-kong Shing, MBBS, FRCP ) |
| Study ID Numbers: | CCFGrants2000.MKS, No |
| Study First Received: | December 17, 2007 |
| Last Updated: | December 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00575926 History of Changes |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
|
Randomized controlled trial Lingzhi Immune functions Quality of life Survival |
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Reishi Quality of Life |
