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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Rosenberg European Academy of Ayurveda
Sponsor:
Collaborator:
EUROPEAN PROFESSIONAL ASSOCIATION OF AYURVEDA PRACTITIONERS AND THERAPISTS
Information provided by (Responsible Party):
Prof. S.N. Gupta, Rosenberg European Academy of Ayurveda
ClinicalTrials.gov Identifier:
NCT02107469
First received: April 3, 2014
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Diabetic Polyneuropathy
Diabetic Neuralgia
Diabetic Neuropathies
Diabetic Neuropathy
Drug: Sida cordifolia roots
Drug: Phyllanthus niruri
Drug: Sida cordifolia roots extract
Drug: Phyllanthus niruri extract
Other: Sida cordifolia placebo
Other: Phyllanthus niruri placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-compared Study on Efficiency of Two Different Administration Forms of Phyllanthus Niruri and Sida Cordifolia in Patients With Diabetic Peripheral Polyneuropathy

Resource links provided by NLM:


Further study details as provided by Rosenberg European Academy of Ayurveda:

Primary Outcome Measures:
  • Improvement of NTSS-6 SCORE in per cent from baseline [ Time Frame: Initially, after 1, 2, 3, 5, 8 weeks of treatment, where placebo group will start again in one of the herbal treatment groups after 3 weeks (9 instead of 6 assessments) ] [ Designated as safety issue: No ]
    Validated symptom score containing 6 questions investigation severity (not present, mild, moderate, severe) and frequency (never or occasional, occasional but normal, often, almost continuous) of symptoms (aching pain, allodynia, burning pain, lancinating pain, numbness, prickling sensation).


Secondary Outcome Measures:
  • Improvement from baseline in per cent of quantitative sensory testing of vibration and thermal (hot/cold) threshold (score) [ Time Frame: Initially, after 1, 2, 3, 5, 8 weeks of treatment, where placebo group will start again in one of the herbal treatment groups after 3 weeks (9 instead of 6 assessments) ] [ Designated as safety issue: No ]

    Semi-automated Neuropathy Analyser Dx from Diabetic Footcare India used to detect vibration and thermal (hot/cold) threshold (both soles)

    Inability to feel vibration up to: Normal: 10Hz below age of 50a and 15Hz above age of 50a = scoring "0"; Mild: 11-15Hz below age of 50a and 16-20Hz above age of 50a = scoring "1"; Moderate: 16-20Hz below age of 50a and 21-25Hz above age of 50a = scoring "2"; Severe: 20Hz below age of 50a and 26Hz above age of 50a = scoring "3"

    Inability to feel cold down to: Normal: 20°C = scoring "0"; Mild: 19-15°C = scoring "1"; Moderate: 14-10°C = scoring "2"; Severe: < 9°C = scoring "3"

    Inability to feel hot up to: Normal: 42°C = scoring "0"; Mild: 43-45°C = scoring "1"; Moderate: 46-48°C = scoring "2"; Severe: > 49°C = scoring "3"

    Temperature of the probe is to be reduced from 30°C to 0°C to record perception of cold sensation and temperature of the probe is to be increased from 30°C up to 50°C to record perception of heat sensations.


  • Assessment of compliance regarding medication and dietary recommendations (score). [ Time Frame: After 1, 2, 3, 5, 8 weeks of treatment, where placebo group will start again in one of the herbal treatment groups after 3 weeks (8 instead of 5 assessments) ] [ Designated as safety issue: No ]

    The used questionaire is an adaption of the warfarin compliance-assessment scale from Community Anticoagulation Therapy Clinic in Iowa. (Huber, Levett, & Atkinson, 2008)

    Medication - Missed doses:

    No dose missed = score "0"

    One dose in a week missed = score "1"

    Two doses in a week missed = score "2"

    Three or more doses missed = score "3"

    Medication - Additional doses:

    No extra dose = score "0"

    One extra dose = score "1"

    Two extra doses = score "2"

    Three or more extra doses in a week = score "3"

    Food habits:

    Completely followed dietary recommendations = score "0"

    One day a week I ignored dietary recommendations = score "1"

    Two days a week I ignored dietary recommendations = score "2"

    Three or more days a week I ignored recommendations = score "3"



Other Outcome Measures:
  • Patient Diary [ Time Frame: From start to end of treatment (8 weeks, 11 weeks for placebo group) ] [ Designated as safety issue: No ]
    With every distributed one-week-package of drug/placebo the patients will get a diary where they are supposed to fill in if medication has been taken (morning/lunch/dinner) and how there symptoms are like (non, mild, moderate, severe) for every single day.


Estimated Enrollment: 120
Study Start Date: June 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ancient herbal treatment

Phyllanthus niruri 3g fine dry powder 3 times a day with warm water before meals for 8 weeks

Sida cordifolia 7g coarse dry powder 2 times a day prepared as traditional decoction before meals for 8 weeks. Decoction: Take provided measurement cup full of water (112ml) and soak one portion (pe-packed) of the powder for 12 hours, then boil it until the upper level has been reduced to 1/4, filter, cool down to room temperature, drink

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
Other Names:
  • Bala moola
  • Bala
Drug: Phyllanthus niruri
Phyllanthus niruri (whole plant) fine powder 3g three times a day with warm water before meals taken orally.
Other Names:
  • Phyllanthus amarus
  • Bhumyamalaki
  • Tamalaki
Experimental: Modern extract herbal treatment

Phyllanthus niruri extract 2 capsules 3 times a day with warm water before meals for 8 weeks

Sida cordifolia roots extract 2 capsules 2 times a day with warm water before meals for 8 weeks

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
Other Names:
  • Bala moola
  • Bala
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 Names:
  • Phyllanthus amarus
  • Bhumyamalaki
  • Tamalaki
Placebo Comparator: Placebo

Phyllanthus niruri placebo 2 capsules 3 times a day with warm water before meals for 3 weeks

Sida cordifolia placebo 2 capsules 2 times a day with warm water before meals for 3 weeks

Other: Sida cordifolia placebo
300mg inert Maltodextrin in gelatine capsule. 2 capsules given 2 times a day orally with warm water before meals
Other Names:
  • Placebo
  • Inert maltodextrine
  • Maltodextrine
Other: Phyllanthus niruri placebo
300mg inert Maltodextrin in gelatine capsule. 2 capsules given 3 times a day orally with warm water before meals
Other Names:
  • Placebo
  • Inert Maltodextrin
  • Maltodextrin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed consent form
  • positive history of type 1 or 2 diabetes mellitus having the symptoms of diabetic neuropathy (sensory, peripheral) will be selected.
  • Only outpatient setting will be included.
  • Patients with ≥2 symptoms having at least one symptom with moderate severity in occasional frequency (3 points in NTSS-6) are included if they additionally show an impaired vibration detection threshold.

Exclusion Criteria:

  • suffering from any other associated clinical conditions influencing peripheral nerve function, for example:
  • peripheral vascular disease if reason for nerve damage
  • vitamin deficiency (FOL,B12,E)
  • heavy metal intoxication (especially with lead, cadmium and thallium)
  • other intoxications (alcohol, medicine)
  • infectious disease (like HIV, typhus, syphilis, lyme disease, mononucleosis,...)
  • cancer
  • autoimmune disease
  • hepatitis
  • vasculitis
  • amyloidosis
  • severe kidney failure
  • pregnancy
  • disorder of connective tissue
  • steroids taken up to 1 month prior to study
  • the likely need for insulin therapy

Regarding prior medication patients are advised not to start additional therapy during the study as long as symptoms are not worsening, antihyperglycaemic drugs will only be adjusted by study physicians if necessary.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02107469

Contacts
Contact: Shivenarain N. Gupta, Prof. Dr. +91 268 2520724 guptayurveda@yahoo.com
Contact: Patel Manish, Dr. +91 9979589865 manishayu97@yahoo.com

Locations
India
P.D. Patel Ayurveda Hospital Recruiting
Nadiad, Gujarat, India, 387001
Contact: Shivenarain N. Gupta, Prof. Dr.    +91 268 2520724    guptayurveda@yahoo.com   
Contact: Patel Manish, Dr.    +91 9979589865    manishayu97@yahoo.com   
Principal Investigator: Shivenarain N. Gupta, Prof. Dr.         
Sub-Investigator: Daniel Scheidbach, Dr.         
Sub-Investigator: Patel Manish, Dr.         
Sub-Investigator: Patel Kalapi, Dr.         
Sub-Investigator: Pankaj Chhayani, Dr.         
Sub-Investigator: Mansi Patel, Dr.         
Sponsors and Collaborators
Rosenberg European Academy of Ayurveda
EUROPEAN PROFESSIONAL ASSOCIATION OF AYURVEDA PRACTITIONERS AND THERAPISTS
Investigators
Principal Investigator: Shivenarain N. Gupta, Prof. Dr. P.D. Patel Ayurveda Hospital / Rosenberg European Academy of Ayurveda
  More Information

Additional Information:
Publications:

Responsible Party: Prof. S.N. Gupta, Superintendent of P.D. Patel Ayurveda Hospital Nadiad, Gujarat, India, Rosenberg European Academy of Ayurveda
ClinicalTrials.gov Identifier: NCT02107469     History of Changes
Other Study ID Numbers: NADIAD 2014
Study First Received: April 3, 2014
Last Updated: July 2, 2014
Health Authority: India: Indian Board of Alternative Medicine

Keywords provided by Rosenberg European Academy of Ayurveda:
Diabetic Polyneuropathy
Diabetic
Polyneuropathy
Ayurvedic
Ayurveda
Neuralgia
Diabetic Neuralgia
Sida cordifolia
Phyllanthus Niruri
Phyllanthus Amarus
Extracts
Extract
Crude Herb
Crude
Herb
Herbal
Herbal Extract
Decoction
Churna
Powder
Bala
Bhumyamalaki
Tamalaki

Additional relevant MeSH terms:
Diabetic Neuropathies
Neuralgia
Polyneuropathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014