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...
Main Authors: | , , , , , , |
---|---|
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 |
_version_ | 1817980108655296512 |
---|---|
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. |
first_indexed | 2024-04-13T22:50:23Z |
format | Article |
id | doaj.art-7fbecd818eb8413daee974d11aebcacd |
institution | Directory Open Access Journal |
issn | 0975-9476 |
language | English |
last_indexed | 2024-04-13T22:50:23Z |
publishDate | 2022-07-01 |
publisher | Elsevier |
record_format | Article |
series | Journal of Ayurveda and Integrative Medicine |
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 |
work_keys_str_mv | AT manishvpatel arandomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy AT mansimpatel arandomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy AT kalapibpatel arandomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy AT pankajvchhayani arandomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy AT martinmittwede arandomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy AT danielscheidbach arandomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy AT shivenarainngupta arandomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy AT manishvpatel randomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy AT mansimpatel randomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy AT kalapibpatel randomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy AT pankajvchhayani randomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy AT martinmittwede randomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy AT danielscheidbach randomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy AT shivenarainngupta randomizedplacebocomparedstudyontheefficacyofclassicalayurvedicpharmaceuticalformversusaqueousalcoholicextractsofphyllanthusnirurilinnplussidacordifolialinninpatientsofdiabeticsensorypolyneuropathy |