A Study of Phyllanthus Niruri and Sida Cordifolia in Diabetic Peripheral Polyneuropathy
Condition: Diabetic Polyneuropathy; Diabetic Neuralgia; Diabetic Neuropathies; Diabetic Neuropathy
MeSH terms: Neuralgia; Diabetic Neuropathies; Polyneuropathies
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Sida cordifolia roots; Phyllanthus niruri; Sida cordifolia roots extract; Phyllanthus niruri extract; Sida cordifolia placebo; Phyllanthus niruri placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other; Other
Intervention description(s): Sida cordifolia roots, crude drug (coarse powder) a plant product 7g (packages prepared) are soaked in 112ml water (measurement cup provided) for 12 hours and then boiled until the level is reduced to 1/4 of hight. Fluid is filtered an drunk after cooling down to room temperature - orally 2 times a day before breakfast and dinner; Phyllanthus niruri (whole plant) fine powder 3g three times a day with warm water before meals taken orally.; gelatine capsule with 300mg Sida cordifolia roots spraydry extract 12:1 concentrated normalized to alkaloids (alcoholic/aqueous extract) - 2 capsules taken orally 2 times a day with warm water before meal; gelatine capsule with 300mg Phyllanthus niruri spray dry extract 5:1 concentrated normalized to bitters (alcohol/aqueous extract) - 2 capsules taken orally 3 times a day with warm water before meal; 300mg inert Maltodextrin in gelatine capsule. 2 capsules given 2 times a day orally with warm water before meals; 300mg inert Maltodextrin in gelatine capsule. 2 capsules given 3 times a day orally with warm water before meals
Other intervention name(s): Bala moola; Bala; Phyllanthus amarus; Bhumyamalaki; Tamalaki; Bala moola; Bala; Phyllanthus amarus; Bhumyamalaki; Tamalaki; Placebo; Inert maltodextrine; Maltodextrine; Placebo; Inert Maltodextrin; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic Polyneuropathy; Diabetic; Polyneuropathy; Ayurvedic; Ayurveda; Neuralgia; Diabetic Neuralgia; Sida cordifolia; Phyllanthus Niruri; Phyllanthus Amarus; Extracts; Extract; Crude Herb; Crude; Herb; Herbal; Herbal Extract; Decoction; Churna; Powder; Bala; Bhumyamalaki; Tamalaki