At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Placebo-compared Study on Efficiency of Two Different Administration Forms of Phyllanthus Niruri and Sida Cordifolia in Patients With Diabetic Peripheral Polyneuropathy
In Brief
A clinical study evaluating Sida cordifolia roots, Phyllanthus niruri, and 4 other interventions for Diabetic Polyneuropathy and 3 related conditions. Completed, enrolled 98 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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