Clinical Study on Basti and Trikatu Gutika in Diabetic Neuropathy

Phase 2

Conditions: Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Recruitment & Eligibility

Inclusion Criteria

Patient willing and able to participate in the study

Patients with clinical signs and symptoms of Diabetic Neuropathy having HBA1C less than

Patient having Diabetic Neuropathy Symptom Gradation Score greater and equal to 3 Diabetic

Neuropathy Examination Score greater and equal to 3

Patients who are suitable for Basti

Patients who had not participated in any research projects since last 6 months

Patients irrespective of sex socio-economical status and religion aged between 30 to 70

years

Patients who follows instructions advised by researcher strictly

Exclusion Criteria

Patient not willing for trial

Patient having severe disease with complication like AIDS Cardiovascular disease Pulmonary disease Tuberculosis malignancy will be rejected

Patients having gross disability in performing daily normal routine

patients or confined to wheelchair

Patients with poorly controlled Hypertension

Patients who were participating in any other clinical trials (since last 6 months)

Patients contraindicated for Basti mentioned in classics

Patient who do not follow instruction suggested by researcher strictly

Pregnant females and lactating mothers

Acute complications of hyperglycemia like DKA

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Mustadi Yapana Basti and Trikatu Gutika in <br/ ><br>management of Diabetic Neuropathy on Diabetic Neuropathy Symptoms <br/ ><br>Score and Diabetic Neuropathy Examination ScoreTimepoint: On 0th day, 6th day, 12th day, 18th day, 24th day, 30th day, 36th day of trial

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the efficacy of Mustadi Yapana Basti & Trikatu Gutika in management <br/ ><br>of Diabetic Neuropathy on Semmes-Weinstein Monofilament Examination & S- LANSS Pain Score. <br/ ><br>2. To study Ayurvedic & modern literature regarding Diabetic NeuropathyTimepoint: On 0th day, 6th day, 12th day, 18th day, 24th day, 30th day, 36th day