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Diabetic PolyneuropathyVEDICINENCT02107469

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

A study testing Sida cordifolia roots, Phyllanthus niruri and Sida cordifolia roots extract in people with Diabetic Polyneuropathy and Diabetic Neuralgia, run by Rosenberg European Academy of Ayurveda at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Sida cordifolia roots, Phyllanthus niruri and Sida cordifolia roots extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
1 siteIndia
Study dates
Jun 2014to Feb 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,...)
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

India1 site

  • P.D. Patel Ayurveda Hospital

    Nadiād, Gujarat, 387001

Other trials in India

About this study

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

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.

Read the detailed description

This study will explore the difference in therapeutic efficiency between modern extracts and whole drug powder of Phyllanthus niruri plus Sida cordifolia root decoction in diabetic neuropathy compared to placebo. The difference in compliance regarding medicine and food recommendations will be additionally documented.

Design - Study in two parts:

Part I: prospective, placebo-controlled, partly double-blinded (regarding 2 of the arms- all arms are investigator-blinded), 3 arm-parallel group study for 3 weeks Part II: prospective, investigator-blinded, long-term-study for 8 weeks. The active groups of part I will continue with their assigned medication and the placebo-patients of part I will be randomized again for the 2 groups of active medication.

Methods:

Symptoms will be assessed using Neuropathy total symptom score 6 (NTSS-6) as main primary parameter. Additional quantitative sensory testing will be done with the Neuropathy Analyzer Vibrotherm Dx from Diabetic Footcare India for detection of vibration and thermal sensation threshold. Tolerability, adverse drug reactions, Compliance regarding medication intake and dietary recommendations will be documented by an additional questionnaire.

Three randomized groups of 30 outpatients each (powder/decoction ; extract ; placebo) will be created for the part I of the study for the first 3 weeks.

At part I placebo group will be double blinded compared to extract group and investigator-blinded to powder/decoction group.

After 3 weeks the patients of the placebo group will be randomly assigned into both active treatment groups for part II to describe the course of treatment with both administration forms with 45 patients each.

Study visits will be prior and after 1,2,3,5 and 8 weeks.

Statistical plan: The primary parameter will be compared by Mann Whitney-U-Test.

Secondary Parameters will be descriptively analysed.

Implication:

A new herbal formulation will be tested for diabetic neuropathy with modern randomized placebo controlled study design in Part I. The outcome of the observation in part II will bring us closer to evidence based selection of different ayurvedic preparations in an upraising marked of new extraction technologies.

Registry procedures and other quality factors:

Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.

Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (medical records, paper case report forms).

Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.

Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.

Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.

Being tested
Sida cordifolia roots, Phyllanthus niruri, Sida cordifolia roots extract, Phyllanthus niruri extract, Sida cordifolia placebo
Keywords
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
Medical subject headings
Diabetic Neuropathies, Polyneuropathies, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sida cordifolia rootsDrug

    Also called Bala moola, Bala

    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 niruriDrug

    Also called Phyllanthus amarus, Bhumyamalaki, Tamalaki

    Phyllanthus niruri (whole plant) fine powder 3g three times a day with warm water before meals taken orally.

  • Sida cordifolia roots extractDrug

    Also called Bala moola, Bala

    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

  • Phyllanthus niruri extractDrug

    Also called Phyllanthus amarus, Bhumyamalaki, Tamalaki

    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

  • Sida cordifolia placeboOther

    Also called Placebo, Inert maltodextrine, Maltodextrine

    300mg inert Maltodextrin in gelatine capsule. 2 capsules given 2 times a day orally with warm water before meals

  • Phyllanthus niruri placeboOther

    Also called Placebo, Inert Maltodextrin, Maltodextrin

    300mg inert Maltodextrin in gelatine capsule. 2 capsules given 3 times a day orally with warm water before meals

Study groups in NCT02107469
Study groupRoleWhat they receive
Ancient herbal treatmentExperimentalPhyllanthus 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
Receives: Drug: Sida cordifolia roots; Drug: Phyllanthus niruri
Modern extract herbal treatmentExperimentalPhyllanthus 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
Receives: Drug: Sida cordifolia roots extract; Drug: Phyllanthus niruri extract
PlaceboPlacebo comparatorPhyllanthus 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
Receives: Other: Sida cordifolia placebo; Other: Phyllanthus niruri placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of NTSS-6 SCORE in per cent from baseline

    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).

    Measured: 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)

Secondary outcomes (2)

  1. Improvement from baseline in per cent of quantitative sensory testing of vibration and thermal (hot/cold) threshold (score)

    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.

    Measured: 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)

  2. Assessment of compliance regarding medication and dietary recommendations (score).

    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"

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02107469
Sponsor's protocol ID
NADIAD 2014
Acronym
VEDICINE
Status last verified
Feb 2016
First submitted
3 Apr 2014
Last updated
24 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Asare GA, Addo P, Bugyei K, Gyan B, Adjei S, Otu-Nyarko LS, Wiredu EK, Nyarko A. Acute toxicity studies of aqueous leaf extract of Phyllanthus niruri. Interdiscip Toxicol. 2011 Dec;4(4):206-10. doi: 10.2478/v10102-011-0031-9.

    PubMed 22319255

  • Bastyr EJ 3rd, Price KL, Bril V; MBBQ Study Group. Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. Clin Ther. 2005 Aug;27(8):1278-94. doi: 10.1016/j.clinthera.2005.08.002.

    PubMed 16199253

  • Boulton AJ. The diabetic foot: from art to science. The 18th Camillo Golgi lecture. Diabetologia. 2004 Aug;47(8):1343-53. doi: 10.1007/s00125-004-1463-y. Epub 2004 Jul 28.

    PubMed 15309286

  • Cornblath, DR. Diabetic neuropathy: Diagnostic methods. Advanced Studies in Medicine 4(8a):650-661, 2004.

  • Dettori J. The random allocation process: two things you need to know. Evid Based Spine Care J. 2010 Dec;1(3):7-9. doi: 10.1055/s-0030-1267062. No abstract available.

    PubMed 22956922

  • Grover JK, Yadav S, Vats V. Medicinal plants of India with anti-diabetic potential. J Ethnopharmacol. 2002 Jun;81(1):81-100. doi: 10.1016/s0378-8741(02)00059-4.

    PubMed 12020931

  • Huber CS, Levett JM, Atkinson JM. A Tool to Assess Compliance in Anticoagulation Management. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 3: Performance and Tools). Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK43677/

    PubMed 21249935

  • Patel K, Patel M, Gupta SN. Effect of Atibalamula and Bhumyamalaki on thirty-three patients of diabetic neuropathy. Ayu. 2011 Jul;32(3):353-6. doi: 10.4103/0974-8520.93913.

    PubMed 22529650

  • Kanth VR, Diwan PV. Analgesic, antiinflammatory and hypoglycaemic activities of Sida cordifolia. Phytother Res. 1999 Feb;13(1):75-7. doi: 10.1002/(SICI)1099-1573(199902)13:13.0.CO;2-F.

    PubMed 10189958

  • Kastenbauer T, Sauseng S, Brath H, Abrahamian H, Irsigler K. The value of the Rydel-Seiffer tuning fork as a predictor of diabetic polyneuropathy compared with a neurothesiometer. Diabet Med. 2004 Jun;21(6):563-7. doi: 10.1111/j.1464-5491.2004.01205.x.

    PubMed 15154940

  • Konate K, Bassole IH, Hilou A, Aworet-Samseny RR, Souza A, Barro N, Dicko MH, Datte JY, M'Batchi B. Toxicity assessment and analgesic activity investigation of aqueous acetone extracts of Sida acuta Burn f . and Sida cordifolia L. (Malvaceae), medicinal plants of Burkina Faso. BMC Complement Altern Med. 2012 Aug 11;12:120. doi: 10.1186/1472-6882-12-120.

    PubMed 22883637

  • Kudom AA, Mensah BA, Botchey MA. Aqueous neem extract versus neem powder on Culex quinquefasciatus: implications for control in anthropogenic habitats. J Insect Sci. 2011;11:142. doi: 10.1673/031.011.14201.

    PubMed 22233153

  • Kumar P. S., et al. Immediate effects of nerve sliders and nerve massage on vibration and thermal perception thresholds in patients with painful diabetic peripheral neuropathy- a pilot randomized clinical trial. Physiotherapy and Occupational Therapy Journal 3(3):5-19, July - Sept 2010

  • Sumanth M, Mustafa SS. Antistress, Adoptogenic Activity of Sida cordifolia Roots in Mice. Indian J Pharm Sci. 2009 May;71(3):323-4. doi: 10.4103/0250-474X.56027.

    PubMed 20490305

  • Neeraj, T., & Parul, S. (2011). Quality standards of indian medicinal plants. New Delhi: Indian Council of Medical Research, Medicinal Plants Unit.

Questions about this trial

What is this clinical trial studying?

A study testing Sida cordifolia roots, Phyllanthus niruri and Sida cordifolia roots extract in people with Diabetic Polyneuropathy and Diabetic Neuralgia, run by Rosenberg European Academy of Ayurveda at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02107469, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.

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