A Study of Phyllanthus Niruri and Sida Cordifolia in Diabetic Peripheral Polyneuropathy (NCT02107469) | Clinical Trial Compass
CompletedNot Applicable
A Study of Phyllanthus Niruri and Sida Cordifolia in Diabetic Peripheral Polyneuropathy
India98 participantsStarted 2014-06
Plain-language 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.
Who can participate
Age range20 Years – 80 Years
SexALL
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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.
What they're measuring
1
Improvement of NTSS-6 SCORE in per cent from baseline
Timeframe: Initially, after 1, 2, 3, 5, 8 weeks of treatment, where placebo group will start again in one of the herbal treatment groups after 3 weeks (9 instead of 6 assessments)