Diabetic Neuropathies Clinical Trial
— VEDICINEOfficial 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.
Status | Completed |
Enrollment | 98 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | P.D. Patel Ayurveda Hospital | Nadiad | Gujarat |
Lead Sponsor | Collaborator |
---|---|
Rosenberg European Academy of Ayurveda | EUROPEAN PROFESSIONAL ASSOCIATION OF AYURVEDA PRACTITIONERS AND THERAPISTS |
India,
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. — View Citation
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. — View Citation
Boulton AJ. The diabetic foot: from art to science. The 18th Camillo Golgi lecture. Diabetologia. 2004 Aug;47(8):1343-53. Epub 2004 Jul 28. Review. — View Citation
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. — View Citation
Grover JK, Yadav S, Vats V. Medicinal plants of India with anti-diabetic potential. J Ethnopharmacol. 2002 Jun;81(1):81-100. Review. — View Citation
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. — View Citation
Kanth VR, Diwan PV. Analgesic, antiinflammatory and hypoglycaemic activities of Sida cordifolia. Phytother Res. 1999 Feb;13(1):75-7. — View Citation
Kästenbauer 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. — View Citation
Konaté K, Bassolé IH, Hilou A, Aworet-Samseny RR, Souza A, Barro N, Dicko MH, Datté 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. — View Citation
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. — View Citation
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
Neeraj, T., & Parul, S. (2011). Quality standards of indian medicinal plants. New Delhi: Indian Council of Medical Research, Medicinal Plants Unit.
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. — View Citation
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. — View Citation
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. — View Citation
Srividya N, Periwal S. Diuretic, hypotensive and hypoglycaemic effect of Phyllanthus amarus. Indian J Exp Biol. 1995 Nov;33(11):861-4. — View Citation
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. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient Diary | 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. | From start to end of treatment (8 weeks, 11 weeks for placebo group) | No |
Primary | 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) | No |
Secondary | 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. |
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) | No |
Secondary | 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" |
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) | No |
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