ActivePhase 2ACTRN12608000388314

Safety and efficacy of Neurotec in reducing pain in patients with diabetic neuropathy - a single armed phase II trial


Sponsor

Tehran University of Medical Sciences

Enrollment

10 participants

Start Date

Aug 1, 2008

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a device called Neurotec to see if it can reduce pain and tingling in people with diabetic neuropathy — nerve damage caused by diabetes that often affects the feet and hands. The study is for adults aged 18 to 75 who have type 1 or type 2 diabetes with painful neuropathy that interferes with daily activities.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Tehran, Iran, Islamic Republic Of

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