None listed
Conditions
Brief 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.
Interventions
Oral 120 mg capsules of Neurotec twice a day for 12 weeks and once a day for another 4 weeks - a herbal exract
Sponsors
Tehran University of Medical Sciences
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
No
Inclusion criteria
having diabetic I or II having pain and paresthesia interfering with every day activities Diminished anckle reflex Abnormal 128 Hz vibration test
Exclusion criteria
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
Outcome results
None listed