Clinical TrialID 387
A Study of Phyllanthus Niruri and Sida Cordifolia in Diabetic Peripheral Polyneuropathy
NCT02107469
Diabetic Polyneuropathy|Diabetic Neuralgia|Diabetic Neuropathies|Diabetic Neuropathy
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 387
- Evidence Id
- 387
- Core Evidence Id
- 387
- Source Clinical Trial Id
- 373
- Herb2 Clinical Trial Id
- HBCT000373
- Nct Id
- NCT02107469
- Title
- A Study of Phyllanthus Niruri and Sida Cordifolia in Diabetic Peripheral Polyneuropathy
- Status
- Completed
- Phase
- Study Result
- No
- Study Condition
- Diabetic Polyneuropathy|Diabetic Neuralgia|Diabetic Neuropathies|Diabetic Neuropathy
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Sida cordifolia roots|DRUG: Phyllanthus niruri|DRUG: Sida cordifolia roots extract|DRUG: Phyllanthus niruri extract|OTHER: Sida cordifolia placebo|OTHER: Phyllanthus niruri placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 98
- Outcome Measure
- 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)
- Sponsor Collaborator
- Rosenberg European Academy of Ayurveda|EUROPEAN PROFESSIONAL ASSOCIATION OF AYURVEDA PRACTITIONERS AND THERAPISTS
- Funded By
- OTHER
- Location
- P.D. Patel Ayurveda Hospital, Nadiad, Gujarat, 387001, India
- Other Id
- NADIAD 2014
- Start Date
- 2014-06
- Primary Completion Date
- 2016-02
- Completion Date
- 2016-02
- First Posted
- 2014-04-08
- Results First Posted
- Last Update Posted
- 2016-02-24
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02107469
- Title Cn
- Title En
- A Study of Phyllanthus Niruri and Sida Cordifolia in Diabetic Peripheral Polyneuropathy
- Bilingual Status
- semi_complete