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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• EUROPEAN PROFESSIONAL ASSOCIATION OF AYURVEDA PRACTITIONERS AND THERAPISTS

  collaborator UNKNOWN

• Rosenberg European Academy of Ayurveda

  lead OTHER

Principal Investigators

• Shivenarain N. Gupta, Prof. Dr. · P.D. Patel Ayurveda Hospital / Rosenberg European Academy of Ayurveda

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2016-02-29

Completion

2016-02-29

Countries

• India

Study Locations