Mitochondrial agents in the treatment of chronic fatigue syndrome: a 20-week, open-label, intervention trial

The University of Melbourne0 个研究点目标入组 30 人开始时间: 2016年5月3日最近更新: 2020年1月13日

适应症

试验速览

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•a. Male and female patients aged 18 to 65 years,
•b. Diagnosed with chronic fatigue syndrome by an independent physician (a letter or referral will be preferred to confirm diagnosis),
•c. Fulfil criteria for CFS as per the US Centres for Disease Control and Prevention (CDC), which requires persistent, unexplained fatigue for at least 6 months, concurrent with at least four of the following, 1) Impaired memory/concentration, 2) Sore throat, new headaches, 3) Unfreshreshing sleep, muscle pain, 4) Multi-joint pain 5)Tender lymph nodes
•6) Post-exertional malaise
•d. Have capacity to consent to the study and comply with study procedures,
•e. Be using effective contraception if female, sexually active and of childbearing age,
•f. Participants currently under any form of therapy will need to have been on that therapy for at least four (4) weeks prior to enrolment.

•a. Patients with known or suspected active and unstable systemic medical disorder,
•b. Patients who have a major depressive episode in the two years preceding the diagnosis of CFS,
•c. Acute suicidality as indicated by a score of 5 or 6 on Item 10 of the MADRS (or at the discretion of Principal Investigator)
•d. Patients with current diagnosis of a psychotic disorder, bipolar disorder, substance abuse/dependence, eating disorder, significant personality disorder,
•e. Recent gastrointestinal ulcers or renal stones,
•f. Individuals who are pregnant or lactating,
•g. Individuals with a diagnosis of epilepsy,
•h. Those who are currently taking any of the study preparations (a 2-week washout period will be required if participants currently taking the study preparations would like to take part) or over 200micrograms of selenium/day,
•i. Individuals currently enrolled in any other intervention study,
•j. Individuals needing warfarin or phenytoin,
•k. Individuals who are intolerant to or have had an anaphylactic reaction to any components of the preparation,
•l. Inability to comply with either the requirements of informed consent or the treatment protocol.

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