NCT02107469

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

A Randomized Placebo-compared Study on Efficiency of Two Different Administration Forms of Phyllanthus Niruri and Sida Cordifolia in Patients With Diabetic Peripheral Polyneuropathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Rosenberg European Academy of Ayurveda · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Polyneuropathy
• Diabetic Neuralgia
• Diabetic Neuropathies
• Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	Sida cordifolia roots	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
DRUG	Phyllanthus niruri	Phyllanthus niruri (whole plant) fine powder 3g three times a day with warm water before meals taken orally.
DRUG	Sida cordifolia roots extract	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
DRUG	Phyllanthus niruri extract	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
OTHER	Sida cordifolia placebo	300mg inert Maltodextrin in gelatine capsule. 2 capsules given 2 times a day orally with warm water before meals
OTHER	Phyllanthus niruri placebo	300mg inert Maltodextrin in gelatine capsule. 2 capsules given 3 times a day orally with warm water before meals

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-04-08
• Last updated: 2016-02-24

Locations

1 site across 1 country: India