Homoeopathy in Diabetic Neuropathy

Phase 3

• Conditions: Health Condition 1: null- Symptoms and Signs of Diabetic Polyneuropathy

• Registration Number: CTRI/2013/07/003818
• Lead Sponsor: Central Council for Research in Homoeopathy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

Both sexes of age between 30-70 years.

Diagnosed cases of Type 2 Diabetes stable with allopathic treatment for last 3 months.

DNE >= 3

Abnormal Nerve conduction test.

HbA1C <= 8%.

Controlled Hypertension

Written Informed consent from the patient.

Exclusion Criteria

i.Diabetic Mononeuropathy

ii.Diabetic Polyradiculopathy

iii.Diabetic amyotrophy

iv.Diabetic Autonomic Neuropathy

v.Abnormalities of gait

vi.Development of typical Charcotâ??s joints, particularly in the feet

vii.Loss of arch with multiple fractures of tarsal bones

viii.Wrist drop

ix.Foot drop

x.Paralysis of III, IV or VI Cranial Nerves

xi.Myocardial infarction less than 6 months

xii.Unstable angina

xiii.Neuropathy due to other causes e.g. Vitamin B12 deficiency.

xiv.Alcohol addiction or dependence

xv.Cases presenting with long term complication of diabetes such as severe retinopathy, severe renal involvement or with history of recurrent acute complications like hypoglycemia, ketoacidosis, polyneuropathy etc.

xvi.Subjects with ill managed diabetes i.e. glycosylated hemoglobin (HbA1c) more than 8%

xvii.Cases with other systemic diseases like cardiovascular, endocrinal diseases like thyroid dysfunction or Systemic infections or on other treatment therapies. (except for hypertensive and dyslipedemic patients on standard care)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the NTSS â?? 6Timepoint: Change in the NTSS â?? 6 from baseline to 12 months post intervention.

Secondary Outcome Measures

Name	Time	Method
â?¢To compare the changes in Serum glycosylated haemoglobinTimepoint: 3rd, 6th, 9th and 12th months between the groups;Change in Diabetic Neuropathy Examination ScoreTimepoint: 12 months;To compare the changes in WHOQOL BREFTimepoint: baseline 3rd, 6th, 9th and 12th month;To compare the Peripheral nerve conduction test and lipid profileTimepoint: 6 and 12 months between the groups