Clinical Study on the effect of an Ayurvedic Treatment on diabetic mellitus patients having neuropathy in the limbs.

Recruiting

Brief Summary: Diabetic foot accounts for one of the largest inpatients admissions in India. The neuropathies are the most common long-term complications of diabetes,affecting up to 50% of patients. There are many patients even withgood glycemic control and oral medications complaining of neuropathic symptomssuch as burning sensation,numbness etc**.**Dasamoola Ksheeradhara can be used as a cost effective and instantaneous solution to the menaceof Diabetic Peripheral Neuropathy

Recruitment & Eligibility

Inclusion Criteria

Diagnosed cases of diabetic neuropathy fulfilling the diagnostic criteria.
Patients having hemoglobin A1c(HbA1c) >6.5% at screening.
Patient having FBS â‰¤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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Biothesio Meter	Day 1,Day 15,Day 45

Secondary Outcome Measures

Name	Time	Method
Blood Glucose Levels	Day 1,Day 15,Day 45
HbA1C	Day 1,Day 45
Neuropathy Total Symptom Score,	Day 1,Day 15,Day 45
Michigan Neuropathy Screening Instrument	Day 1,Day 15,Day 45
Quality of Life using Nottingham health profile	Day 1,Day 15,Day 45

Locations (1): Sreedhareeyam Ayurvedic Eye Hospital and Research Center
🇮🇳
Ernakulam, KERALA, India
Sreedhareeyam Ayurvedic Eye Hospital and Research Center
🇮🇳Ernakulam, KERALA, India
DrAnjaly NV
Principal investigator
9745005913
dranjaly@sreedhareeyam.com