A randomized placebo-compared study on the efficacy of classical ayurvedic pharmaceutical form versus aqueous alcoholic extracts of Phyllanthus niruri Linn. Plus Sida cordifolia Linn. in patients of diabetic sensory polyneuropathy

Background: In routine, Ayurveda practitioners prefer classical pharmaceutical form of herbal medicines in compare to modern extracts. Objective: To explore the difference of efficiency between whole drug powder of Phyllanthus niruri plus root decoction of Sida cordifolia and modern extracts of the...

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Main Authors: Manish V. Patel, Mansi M. Patel, Kalapi B. Patel, Pankaj V. Chhayani, Martin Mittwede, Daniel Scheidbach, Shivenarain N. Gupta
Format: Article
Language:English
Published: Elsevier 2022-07-01
Series:Journal of Ayurveda and Integrative Medicine
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S097594762200078X
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author Manish V. Patel
Mansi M. Patel
Kalapi B. Patel
Pankaj V. Chhayani
Martin Mittwede
Daniel Scheidbach
Shivenarain N. Gupta
author_facet Manish V. Patel
Mansi M. Patel
Kalapi B. Patel
Pankaj V. Chhayani
Martin Mittwede
Daniel Scheidbach
Shivenarain N. Gupta
author_sort Manish V. Patel
collection DOAJ
description Background: In routine, Ayurveda practitioners prefer classical pharmaceutical form of herbal medicines in compare to modern extracts. Objective: To explore the difference of efficiency between whole drug powder of Phyllanthus niruri plus root decoction of Sida cordifolia and modern extracts of the same in compared to placebo in patients of diabetic poly-neuropathy. Material and methods: A randomized, partly-double-blinded, placebo-controlled trial evaluated the efficacy of two different pharmaceutical forms of herbal medicines over placebo in 90 patients (30 in each group) of diabetic sensory polyneuropathy for first three weeks period. After three weeks, active herbal medication groups were continued with their assigned medicaments for next 5 weeks period and all placebo-patients were randomized again into 2 groups of active medication and treated for next 8 weeks. Patients were assessed with Neuropathy Total Symptom Score 6 and sensation thresholds. Results: Significant effect of both form of herbal medicines over placebo was found in aching pain [F (2, 49) = 6.79, p = 0.002], allodynia [F (2, 59) = 6.74, p = 0.002], burning pain [F (2, 82) = 14.66, p < 0.0001], numbness [F (2, 77) = 16.37, p < 0.0001] and pricking pain [F (2, 50) = 14.23, p < 0.0001]. After the 8 weeks period, no significant difference was identified between the effect of both the herbal treatment on aching pain (U = 220, p = 0.03), allodynia (U = 421.5, p = 0.29), burning pain (U = 881.5, p = 0.846), numbness (U = 778, p = 0.92) and pricking pain (U = 260, p = 0.15). Conclusion: Both herbal groups have significant effect to reduce NTSS-6 score in compare to placebo. No significant difference found between the effect of two different pharmaceutical forms of Phyllanthus niruri and S. cordifolia.
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spelling doaj.art-7fbecd818eb8413daee974d11aebcacd2022-12-22T02:26:13ZengElsevierJournal of Ayurveda and Integrative Medicine0975-94762022-07-01133100619A randomized placebo-compared study on the efficacy of classical ayurvedic pharmaceutical form versus aqueous alcoholic extracts of Phyllanthus niruri Linn. Plus Sida cordifolia Linn. in patients of diabetic sensory polyneuropathyManish V. Patel0Mansi M. Patel1Kalapi B. Patel2Pankaj V. Chhayani3Martin Mittwede4Daniel Scheidbach5Shivenarain N. Gupta6Department of Kayachikitsa, J. S. Ayurved Mahavidyalaya, Nadiad, India; Corresponding author.Department of Panchakarma, J. S. Ayurved Mahavidyalaya, Nadiad, IndiaDepartment of Panchakarma, J. S. Ayurved Mahavidyalaya, Nadiad, IndiaDepartment of Kayachikitsa, J. S. Ayurved Mahavidyalaya, Nadiad, IndiaGoethe University Frankfurt / Main and Rosenberg European Academy for Ayurveda, Birstein, GermanyInstitute of Physiology, Medical University of Graz, AustriaDepartment of Kayachikitsa, J. S. Ayurved Mahavidyalaya, Nadiad, IndiaBackground: In routine, Ayurveda practitioners prefer classical pharmaceutical form of herbal medicines in compare to modern extracts. Objective: To explore the difference of efficiency between whole drug powder of Phyllanthus niruri plus root decoction of Sida cordifolia and modern extracts of the same in compared to placebo in patients of diabetic poly-neuropathy. Material and methods: A randomized, partly-double-blinded, placebo-controlled trial evaluated the efficacy of two different pharmaceutical forms of herbal medicines over placebo in 90 patients (30 in each group) of diabetic sensory polyneuropathy for first three weeks period. After three weeks, active herbal medication groups were continued with their assigned medicaments for next 5 weeks period and all placebo-patients were randomized again into 2 groups of active medication and treated for next 8 weeks. Patients were assessed with Neuropathy Total Symptom Score 6 and sensation thresholds. Results: Significant effect of both form of herbal medicines over placebo was found in aching pain [F (2, 49) = 6.79, p = 0.002], allodynia [F (2, 59) = 6.74, p = 0.002], burning pain [F (2, 82) = 14.66, p < 0.0001], numbness [F (2, 77) = 16.37, p < 0.0001] and pricking pain [F (2, 50) = 14.23, p < 0.0001]. After the 8 weeks period, no significant difference was identified between the effect of both the herbal treatment on aching pain (U = 220, p = 0.03), allodynia (U = 421.5, p = 0.29), burning pain (U = 881.5, p = 0.846), numbness (U = 778, p = 0.92) and pricking pain (U = 260, p = 0.15). Conclusion: Both herbal groups have significant effect to reduce NTSS-6 score in compare to placebo. No significant difference found between the effect of two different pharmaceutical forms of Phyllanthus niruri and S. cordifolia.http://www.sciencedirect.com/science/article/pii/S097594762200078XDiseaseMetabolic disordersDiabetes mellitusChronic complicationsDiabetic polyneuropathyTraditional herbal medicine
spellingShingle Manish V. Patel
Mansi M. Patel
Kalapi B. Patel
Pankaj V. Chhayani
Martin Mittwede
Daniel Scheidbach
Shivenarain N. Gupta
A randomized placebo-compared study on the efficacy of classical ayurvedic pharmaceutical form versus aqueous alcoholic extracts of Phyllanthus niruri Linn. Plus Sida cordifolia Linn. in patients of diabetic sensory polyneuropathy
Journal of Ayurveda and Integrative Medicine
Disease
Metabolic disorders
Diabetes mellitus
Chronic complications
Diabetic polyneuropathy
Traditional herbal medicine
title A randomized placebo-compared study on the efficacy of classical ayurvedic pharmaceutical form versus aqueous alcoholic extracts of Phyllanthus niruri Linn. Plus Sida cordifolia Linn. in patients of diabetic sensory polyneuropathy
title_full A randomized placebo-compared study on the efficacy of classical ayurvedic pharmaceutical form versus aqueous alcoholic extracts of Phyllanthus niruri Linn. Plus Sida cordifolia Linn. in patients of diabetic sensory polyneuropathy
title_fullStr A randomized placebo-compared study on the efficacy of classical ayurvedic pharmaceutical form versus aqueous alcoholic extracts of Phyllanthus niruri Linn. Plus Sida cordifolia Linn. in patients of diabetic sensory polyneuropathy
title_full_unstemmed A randomized placebo-compared study on the efficacy of classical ayurvedic pharmaceutical form versus aqueous alcoholic extracts of Phyllanthus niruri Linn. Plus Sida cordifolia Linn. in patients of diabetic sensory polyneuropathy
title_short A randomized placebo-compared study on the efficacy of classical ayurvedic pharmaceutical form versus aqueous alcoholic extracts of Phyllanthus niruri Linn. Plus Sida cordifolia Linn. in patients of diabetic sensory polyneuropathy
title_sort randomized placebo compared study on the efficacy of classical ayurvedic pharmaceutical form versus aqueous alcoholic extracts of phyllanthus niruri linn plus sida cordifolia linn in patients of diabetic sensory polyneuropathy
topic Disease
Metabolic disorders
Diabetes mellitus
Chronic complications
Diabetic polyneuropathy
Traditional herbal medicine
url http://www.sciencedirect.com/science/article/pii/S097594762200078X
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