NCT02107469

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1.7 years

First QC Date

April 3, 2014

Last Update Submit

February 23, 2016

Conditions

Diabetic PolyneuropathyDiabetic NeuralgiaDiabetic NeuropathiesDiabetic Neuropathy

Keywords

Diabetic PolyneuropathyDiabeticPolyneuropathyAyurvedicAyurvedaNeuralgiaDiabetic NeuralgiaSida cordifoliaPhyllanthus NiruriPhyllanthus AmarusExtractsExtractCrude HerbCrudeHerbHerbalHerbal ExtractDecoctionChurnaPowderBalaBhumyamalakiTamalaki

Outcome Measures

Primary Outcomes (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).

    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)

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

    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)

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

    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)

Other Outcomes (1)

  • Patient Diary

    From start to end of treatment (8 weeks, 11 weeks for placebo group)

Study Arms (3)

Ancient herbal treatment

EXPERIMENTAL

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 rootsDrug: Phyllanthus niruri

Modern extract herbal treatment

EXPERIMENTAL

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 extractDrug: Phyllanthus niruri extract

Placebo

PLACEBO COMPARATOR

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 placeboOther: Phyllanthus niruri placebo

Interventions

Sida cordifolia rootsDRUG

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

Also known as: Bala moola, Bala
Ancient herbal treatment
Phyllanthus niruriDRUG

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

Also known as: Phyllanthus amarus, Bhumyamalaki, Tamalaki
Ancient herbal treatment
Sida cordifolia roots extractDRUG

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

Also known as: Bala moola, Bala
Modern extract herbal treatment
Phyllanthus niruri extractDRUG

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

Also known as: Phyllanthus amarus, Bhumyamalaki, Tamalaki
Modern extract herbal treatment
Sida cordifolia placeboOTHER

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

Also known as: Placebo, Inert maltodextrine, Maltodextrine
Placebo
Phyllanthus niruri placeboOTHER

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

Also known as: Placebo, Inert Maltodextrin, Maltodextrin
Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

P.D. Patel Ayurveda Hospital

Nadiād, Gujarat, 387001, India

Location

Related Publications (18)

  • 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.

    PMID: 22319255BACKGROUND

  • 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.

    PMID: 16199253BACKGROUND

  • 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.

    PMID: 15309286BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 22956922BACKGROUND

  • 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.

    PMID: 12020931BACKGROUND

  • 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/

    PMID: 21249935BACKGROUND

  • 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.

    PMID: 22529650BACKGROUND

  • 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.

    PMID: 10189958BACKGROUND

  • 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.

    PMID: 15154940BACKGROUND

  • 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.

    PMID: 22883637BACKGROUND

  • 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.

    PMID: 22233153BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 20490305BACKGROUND

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

    BACKGROUND

  • Shy ME, Frohman EM, So YT, Arezzo JC, Cornblath DR, Giuliani MJ, Kincaid JC, Ochoa JL, Parry GJ, Weimer LH; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Quantitative sensory testing: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2003 Mar 25;60(6):898-904. doi: 10.1212/01.wnl.0000058546.16985.11.

    PMID: 12654951BACKGROUND

  • Smieja M, Hunt DL, Edelman D, Etchells E, Cornuz J, Simel DL. Clinical examination for the detection of protective sensation in the feet of diabetic patients. International Cooperative Group for Clinical Examination Research. J Gen Intern Med. 1999 Jul;14(7):418-24. doi: 10.1046/j.1525-1497.1999.05208.x.

    PMID: 10417599BACKGROUND

  • Srividya N, Periwal S. Diuretic, hypotensive and hypoglycaemic effect of Phyllanthus amarus. Indian J Exp Biol. 1995 Nov;33(11):861-4.

    PMID: 8786163BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetic NeuropathiesPolyneuropathiesNeuralgia

Interventions

4-bromobenzoyl-(alpha-aminoisobutyric acid)(5)-leucyl-(alpha-aminoisobutyric acid)(2)-methoxymaltodextrin

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shivenarain N. Gupta, Prof. Dr.

    P.D. Patel Ayurveda Hospital / Rosenberg European Academy of Ayurveda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Superintendent of P.D. Patel Ayurveda Hospital Nadiad, Gujarat, India

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 8, 2014

Study Start

June 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

IN(1)