Clinical Study on the effect of an Ayurvedic Treatment on diabetic mellitus patients having neuropathy in the limbs.
- Conditions
- Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
- Registration Number
- CTRI/2019/01/016983
- Lead Sponsor
- Dr Anjaly NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Diagnosed cases of diabetic neuropathy fulfilling the diagnostic criteria.
Patients having hemoglobin A1c(HbA1c) >6.5% at screening.
Patient having FBS <=200 mg/dL at screening.
Patients currently treated with Standerd care in Modern medicine.
Patient willing to give a signed informed consent form prior to start of the study.
Patient has hypersensitivity to any of the study medications
Patient is a nursing mother, Pregnant.
Patient has used injected anesthetics or steroids within 30 days of baseline.
Known cases of Skinleisons, malignancy,, any non-diabetic neurologic disorders, seriouds health issues
Patient has certain conditions that could confound evaluation of DPN, in particular, amputations other than toes, (e.g. phantom limb pain), and skin conditions affecting sensation in painful limbs.
Patient has skin conditions in the area affected by the neuropathy that could alter sensation.
Patient is in an immunocompromised state.
Patient has any abnormal chemistry or hematology results that are deemed by the investigator to be clinically significant.
Patient has a history of pernicious anemia, untreated hypothyroidism, chronic hepatitis B or C, hepatitis within the past 3 months, or HIV infection.
Patient has any other serious medical condition.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biothesio MeterTimepoint: Day 1,Day 15,Day 45
- Secondary Outcome Measures
Name Time Method Blood Glucose LevelsTimepoint: Day 1,Day 15,Day 45;HbA1CTimepoint: Day 1,Day 45;Michigan Neuropathy Screening InstrumentTimepoint: Day 1,Day 15,Day 45;Neuropathy Total Symptom Score,Timepoint: Day 1,Day 15,Day 45;Quality of Life using Nottingham health profileTimepoint: Day 1,Day 15,Day 45