Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT00065702
Eligibility Criteria:
Inclusion criteria:
* ACR diagnosis of fibromyalgia;
* Willing to take daily active or placebo liquid remedy under double blind conditions for 6 months, involving daily succussion and dilution of source liquid from a stock bottle;
* Willingness/ability to comply with dietary and lifestyle restrictions, i.e., no coffee in any form, no comphor or menthol-containing products; no electric blankets, no strong aromatics, no routine vaccinations, no concomitant use of acupuncture, chiropractic, polarity therapy, psychic healing, or magnet therapy;
* No dental drilling, MRI scans unless emergent;
* Withhold food or drink 30 mins before/after therapy;
* Stable conventional care for 2 months prior to entry;
* Willing to undergo 3 diagnostic physical exams, and to permit videotaping of interview sessions;
* Willing to fill out questionnaires
Exclusion criteria:
* Steroid-dependent medical conditions;
* Chronic benzodiazepine or anticonvulsant use;
* Use of tricyclic antidepressants, antihypertensives, and other drugs that alter orthostasis;
* Pregnancy;
* History of seizure disorder or syncope;
* Life-threatening medical conditions;
* Current active asthma;
* History of anaphylactic shock;
* Insulin-dependent diabetes;
* Active suicidal ideation or psychosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00065702
Study Brief:
Protocol Section:
NCT00065702