Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer
NCT ID: NCT05754801
Last Updated: 2023-03-09
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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NOT_YET_RECRUITING
PHASE2
172 participants
INTERVENTIONAL
2023-04-01
2026-09-30
Brief Summary
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Detailed Description
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Quality of life (QOL) of patients is the ultimate goal of palliative care as endorsed by the World Health Organization (WHO) in 1990. When survival is limited in advanced incurable diseases, quality of life is most important. Patients with advanced cancer (palliative) often manifest numerous physical and psychological symptoms and a poor quality of life. While maintenance of the quality of life of advanced cancer patients is important, the physical dimension of quality of life still needs improvement, especially in the palliative stage. To date, there is no specific supportive Traditional Chinese Medicine(TCM)-related products that have been proven in randomized controlled trials for alleviating these debilitating symptoms and improving their quality of life. The present study aims to scientifically evaluate whether a Yunzhi product named G.E. Yunzhi-Essence is effective and safe in improving the QOL of palliative patients with advanced cancer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Active treatment (Yunzhi Essence)
Subjects will take 2 Yunzhi capsules, 4 times daily, for 6 months.
Yunzhi Essence
Yunzhi Essence capsule
Placebo
Subjects will take 2 placebo capsules, 4 times daily, for 6 months
Placebo
Placebo capsules
Interventions
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Yunzhi Essence
Yunzhi Essence capsule
Placebo
Placebo capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* According to the experience of the doctor, by using Palliative Prognostic Index (score\>4), integrated with past cases and professional knowledge judged to have life expectancy not less than six months to two years;
* Abbreviated mental test (AMT) score of 6 or above;
* Voluntarily participate in this clinical trial and sign the informed consent form (acceptance of close relatives signed informed consent on behalf of the patient);
* Refer to the national standard for Clinic terminology of traditional Chinese medical diagnosis and treatment-Part 2:Syndromes/patterns, syndrome of "damp heat spleen" and "spleen deficiency with water stop" (Fulfill 2 of the main symptoms and 2 of the secondary symptoms).
Exclusion Criteria
* Patients who required nasal feeding or difficulty swallowing;
* Patients with comatose/semi-conscious, cognitively impaired with dementia/confusion, physically too ill with extremely poor general condition, or there was a language barrier.
21 Years
89 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Prof. Lin Zhixiu
Professor
Principal Investigators
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Zhixiu Lin
Role: PRINCIPAL_INVESTIGATOR
Hong Kong Institute of Integrative Medicine
Central Contacts
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Other Identifiers
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Yunzhi study
Identifier Type: -
Identifier Source: org_study_id
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