Diabetic Neuropathies Clinical Trial
Official title:
A Randomized Placebo-compared Study on Efficiency of Two Different Administration Forms of Phyllanthus Niruri and Sida Cordifolia in Patients With Diabetic Peripheral Polyneuropathy
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.
This study will explore the difference in therapeutic efficiency between modern extracts and
whole drug powder of Phyllanthus niruri plus Sida cordifolia root decoction in diabetic
neuropathy compared to placebo. The difference in compliance regarding medicine and food
recommendations will be additionally documented.
Design - Study in two parts:
Part I: prospective, placebo-controlled, partly double-blinded (regarding 2 of the arms- all
arms are investigator-blinded), 3 arm-parallel group study for 3 weeks Part II: prospective,
investigator-blinded, long-term-study for 8 weeks. The active groups of part I will continue
with their assigned medication and the placebo-patients of part I will be randomized again
for the 2 groups of active medication.
Methods:
Symptoms will be assessed using Neuropathy total symptom score 6 (NTSS-6) as main primary
parameter. Additional quantitative sensory testing will be done with the Neuropathy Analyzer
Vibrotherm Dx from Diabetic Footcare India for detection of vibration and thermal sensation
threshold. Tolerability, adverse drug reactions, Compliance regarding medication intake and
dietary recommendations will be documented by an additional questionnaire.
Three randomized groups of 30 outpatients each (powder/decoction ; extract ; placebo) will
be created for the part I of the study for the first 3 weeks.
At part I placebo group will be double blinded compared to extract group and
investigator-blinded to powder/decoction group.
After 3 weeks the patients of the placebo group will be randomly assigned into both active
treatment groups for part II to describe the course of treatment with both administration
forms with 45 patients each.
Study visits will be prior and after 1,2,3,5 and 8 weeks.
Statistical plan: The primary parameter will be compared by Mann Whitney-U-Test.
Secondary Parameters will be descriptively analysed.
Implication:
A new herbal formulation will be tested for diabetic neuropathy with modern randomized
placebo controlled study design in Part I. The outcome of the observation in part II will
bring us closer to evidence based selection of different ayurvedic preparations in an
upraising marked of new extraction technologies.
Registry procedures and other quality factors:
Data checks to compare data entered into the registry against predefined rules for range or
consistency with other data fields in the registry.
Source data verification to assess the accuracy, completeness, or representativeness of
registry data by comparing the data to external data sources (medical records, paper case
report forms).
Standard Operating Procedures to address registry operations and analysis activities, such
as patient recruitment, data collection, data management, data analysis, reporting for
adverse events, and change management.
Sample size assessment to specify the number of participants or participant years necessary
to demonstrate an effect.
Statistical analysis plan describing the analytical principles and statistical techniques to
be employed in order to address the primary and secondary objectives, as specified in the
study protocol or plan.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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