Safety and efficacy of Neurotec in reducing pain in patients with diabetic neuropathy - a single armed phase II trial
Tehran University of Medical Sciences
10 participants
Aug 1, 2008
Interventional
Conditions
Summary
This is a phase II, single armed, trial of Safety and Efficacy of Neurotec, a herbal extract. After signing a consent form 10 paients will be recruited into this trial during which they will recieve oral capsules of Neurotec twice a day for 12 weeks and once a day for another 4 weeks. Every 2 weeks a detailed clinical and laboratory examination will be carried out. this will continue up to 24 weeks. Primary outcome measure is pain which will be measured on 2 week intervals. Secondary outcome measures are michigan and UK diabetic neuropathy score.
Eligibility
Inclusion Criteria4
- having diabetic I or II
- having pain and paresthesia interfering with every day activities
- Diminished anckle reflex
- Abnormal 128 Hz vibration test
Exclusion Criteria10
- Unwilling to sign a written consent
- Non-diabetic neuropathy
- Wound infection or infection in extremities
- ischaemic heart disease
- Heart failure
- reeiving immunosuppresive drugs, corticosteroids, chemotherapy, radiotherapy
- Alcohol and substance misuse
- Electrolyte disturbances
- History of known hypersensitivity to drugs
- Haemodialysis
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Interventions
Oral 120 mg capsules of Neurotec twice a day for 12 weeks and once a day for another 4 weeks - a herbal exract
Locations(1)
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ACTRN12608000388314