Before and after clinical trial of Neourotec on patient with fibromyalgia

Before & after clinical trial of Neurotec's (a pharmasutical drug) on reducing pain in patients with fibromyalgia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000071325

Enrollment

Registered

2008-02-08

Start date

2008-04-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Evaluate the safety and efficacy effect of Neurotec on fibromyalgia and its signs and symptoms. It is hypothesized that Neurotec is a safe drug and effective in reducing the pain, GI disorder, sleep disorder and treatment of Fibromialgia.

Interventions

Neurotec administered orally, one capsules containing 100mg of effective substance every 12 hours for 8 weeks. Totally 112 capsule will consume with volunteers during 56 days. Subjects evaluate on bi-weekly basis during treatment and also 4 & 8 weeks after treatment.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Fibromyalgic disorder symptoms based on USA Rheumatologic association' criteria

Exclusion criteria

Nonvolunteers Hypothyroidism Rheumatologic disorders Psychotic disorders Sever Congestive Heart Failer (CHF) Sever and chronic ischemic heart disorder with pulsless limb Sever disease: Cancers, Vasculitis Alcohol or Drug abuse Chronic renal failer Dialysis Sever hepatic failer Treatment with corticosteroids Immuno suppressive therapy Radiotherapy Chemotherapy Any hypersentivity disorder Electrolytes disorder

Outcome results