An interventional study of melatonin plus zinc and Placebo in Fatigue Syndrome, Chronic and Myalgic Encephalomyelitis, sponsored by Laboratorios Viñas, S.A.. Completed at 1 site in Spain. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-09.
Sponsored by Laboratorios Viñas, S.A. · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the effects of oral melatonin plus zinc supplementation in relieving self-reported fatigue in CFS/ME
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) is a complex medical condition, characterized by severe disabling fatigue with no known cause, no established diagnostic tests, and no universally effective treatment. No studies have evaluated symptomatic treatment using oral melatonin plus zinc supplementation in CFS/ME. The primary endpoint was to assess the effect of melatonin plus zinc supplementation on self-reported fatigue. Secondary measures included self-reported outcomes of sleep problems, anxiety/depression, dysautonomia, QoL and side-effects during treatment.
263 studies on the registry are indexed under Fatigue Syndrome, Chronic; 61 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 177 interventional studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →Laboratorios Viñas, S.A. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Melatonin plus Zinc
Dietary Supplement: melatonin plus zinc
Isomaltose
Other: Placebo
To evaluate relieving self-reported fatigue using the Fatigue Impact Scale 40-items (FIS 40) questionnaire after oral melatonin plus zinc administration
Time frame: within the first 16 weeks (plus 4 weeks with no treatment)
Side effects during treatment.
Time frame: within the first 16 weeks (plus 4 weeks with no treatment)
Self-reported sleep quality through the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
Time frame: within the first 16 weeks (plus 4 weeks with no treatment)
Self-reported anxiety/depression through the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Time frame: within the first 16 weeks (plus 4 weeks with no treatment)
Self-reported dysautonomia using the Composite Autonomic Symptom Score 31-items (COMPASS 31) questionnaire.
Time frame: within the first 16 weeks (plus 4 weeks with no treatment)
Self-reported QoL through the Short Form Health Survey 36-items (SF-36) questionnaire.
Time frame: within the first 16 weeks (plus 4 weeks with no treatment)
Plan to share: No
The record gives a start of Feb 2016, a primary completion of Jul 2017 and a completion of Sep 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Melatonin · Zinc
Laboratorios Viñas, S.A.