A Study of Phyllanthus Niruri and Sida Cordifolia in Diabetic Peripheral Polyneuropathy

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether phyllanthus niruri and sida cordifolia are effective in treatment of diabetic polyneuropathy compared to placebo. Also two different administration forms (extract capsules and crude herbs) are used to find out whether there are differences in efficiency and compliance.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rosenberg European Academy of Ayurveda
• Collaborator: EUROPEAN PROFESSIONAL ASSOCIATION OF AYURVEDA PRACTITIONERS AND THERAPISTS

Criteria

Inclusion Criteria:

• Signed consent form

• positive history of type 1 or 2 diabetes mellitus having the symptoms of diabetic neuropathy (sensory, peripheral) will be selected.

• Only outpatient setting will be included.

• Patients with ≥2 symptoms having at least one symptom with moderate severity in occasional frequency (3 points in NTSS-6) are included if they additionally show an impaired vibration detection threshold.

Exclusion Criteria:

• suffering from any other associated clinical conditions influencing peripheral nerve function, for example:

• peripheral vascular disease if reason for nerve damage

• vitamin deficiency (FOL,B12,E)

• heavy metal intoxication (especially with lead, cadmium and thallium)

• other intoxications (alcohol, medicine)

• infectious disease (like HIV, typhus, syphilis, lyme disease, mononucleosis,...)

• cancer

• autoimmune disease

• hepatitis

• vasculitis

• amyloidosis

• severe kidney failure

• pregnancy

• disorder of connective tissue

• steroids taken up to 1 month prior to study

• the likely need for insulin therapy

Regarding prior medication patients are advised not to start additional therapy during the study as long as symptoms are not worsening, antihyperglycaemic drugs will only be adjusted by study physicians if necessary.