None listed
Conditions
Brief summary
Background: Fibromyalgia is characterized by chronic pain and other symptoms like fatigue, reduced health-related quality of life, poor physical functioning, or disrupted sleep. Ganoderma lucidum has been reported to be safety in humans for reducing pain, fatigue, improves the sleep quality and the health-related quality of life in different populations. Ceratonia siliqua is able to reduce blood cholesterol and glucose, while improving intestinal function and have an antidepressant activity. The present study aims to evaluate the safety and cost-effectiveness of both natural treatments in patients suffering from fibromyalgia. Methods/design: A double-blind randomized control trial will be developed. A total of 66 patients with fibromyalgia will participate in the study and will be randomly assigned to the Ganoderma lucidum (GL) group” or the Ceratonia siliqua (CS) group. The first group will take 6g daily of Ganoderma lucidum during 6 weeks, while the second group will take the same dose of Ceratonia siliqua flour. A three-week follow-up will be carried out after the end of the treatment. Discussion: To our knowledge, this is the first study designed to assess the safety and cost-effectiveness of Ganoderma lucidum and Ceratonia siliqua in patients with FM. If our hypothesis were proved, the results of this study would provide a safe, natural and relatively low-cost alternative to treat the FM symptoms.
Interventions
The sample will be divided in two groups by one author that does not participate directly neither in the assessment nor in statistic analyses. The groups will be two: the Ganoderma lucidum (GL) group and the Ceratonia siliqua (CS) group. Patients will know that there are two groups and they can be in any of them, but they will not know the group they belong. Given that, the current trial is a double-blind study, neither the patient nor the researcher will know the group the patient has been assi
The sample will be divided in two groups by one author that does not participate directly neither in the assessment nor in statistic analyses. The groups will be two: the Ganoderma lucidum (GL) group and the Ceratonia siliqua (CS) group. Patients will know that there are two groups and they can be in any of them, but they will not know the group they belong. Given that, the current trial is a double-blind study, neither the patient nor the researcher will know the group the patient has been assigned. The GL group will take the micromilled GL. The dose will consist on 6g daily for six weeks. The intakes will consist of 3 grams of GL for two times a day, one intake during or immediately after breakfast and one during or immediately after dinner. The administration will be dissolved in warm water and orally ingested. The GL will be provided by the company “MundoReishi” and will be analyzed by the Chair of Mycology of the University of Valladolid, Spain. The CS group will receive a daily dose of CS flour, which consist on 6g of powder coming from Carob tree (CS). This substance looks very similar to the micromilled GL. The administration will be exactly the same than the other group.
Sponsors
Francesco Pazzi
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be diagnosed with fibromyalgia; 2. Be able to communicate effectively with study staff; 3. Be aged more than 18 years; 4. Give written informed consent.
Exclusion criteria
1. Be pregnant; 2. Change the daily life habits during the six weeks of treatment; 3. Take immunosuppressive; 4. Suffer diabetes; 5. Participating in other studies; 6. Take C vitamin supplementation; 7. Take anticoagulants; Patients may abandon the trial if some circumstances happen: they withdraw informed consent, the researcher or their general practitioner feel that they should withdraw from the study for reasons of safety and the patient does not comply with the treatment for more than 80% of the dose.
Outcome results
None listed