A Randomized Placebo-compared Study on Efficiency of Two Different Administration Forms of Phyllanthus Niruri and Sida Cordifolia in Patients With Diabetic Peripheral Polyneuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Improvement of NTSS-6 SCORE in per cent from baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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,...)
- •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.
研究组 & 干预措施
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
干预措施: Sida cordifolia roots (Drug)
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
干预措施: Phyllanthus niruri (Drug)
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
干预措施: Sida cordifolia roots extract (Drug)
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
干预措施: Phyllanthus niruri extract (Drug)
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
干预措施: Sida cordifolia placebo (Other)
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
干预措施: Phyllanthus niruri placebo (Other)
结局指标
主要结局
Improvement of NTSS-6 SCORE in per cent from baseline
时间窗: 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)
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).
次要结局
- 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))
- 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))
研究者
Prof. S.N. Gupta
Superintendent of P.D. Patel Ayurveda Hospital Nadiad, Gujarat, India
Rosenberg European Academy of Ayurveda