A clinical study to compare medicinal leech therapy( jaloukavacharana) versus drug gugguluthikthaka taila combined with medicinal leech therapy in lower extremity peripheral arterial disease associated with type 2 diabetes mellitus

Phase 3

Conditions: Health Condition 1: I702- Atherosclerosis of native arteriesof the extremities

Registration Number: CTRI/2023/12/060496

Lead Sponsor: Dr.Deepa Jose

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.LE-PAD in known T2DM patients diagnosed by clinical examination and colour Doppler study of lower limb arteries.

2.IC due to unilateral or bilateral PAD (Rutherford 1-3) or Rutherford category 0 with atherosclerotic plaques in either femoropopliteal or below popliteal arteries in arterial Doppler study.

3.Age group 40-75 years

4.Atherosclerosis of femoropopliteal and below popliteal arteries in colour Doppler study.

5.Informed written consent

Exclusion Criteria

1.Advanced PAD beyond IC (rest pain, ulcer, gangrene, Rutherford 4-6)

2.Prior revascularization in lower extremities in previous 12 months.

3.Neurogenic/venous/orthopedic claudication more dominant than arterial.

2.Acute PAD

3.Buerger’s disease

4.Known cases of Diabetic nephropathy, liver disease, cancer, obesity

5.Contra indication of snehana

6.Cardiac failure

7.Uncontrolled hypertension

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in 6 – minutes walking distance (6MWD)Timepoint: Measurement of 6 – minutes walking distance (6MWD) - 0th, 45th and 61st days of study period.

Secondary Outcome Measures

Name	Time	Method
1.Rutherford clinical classification of PAD <br/ ><br>2. Colour doppler study of arterial system of affected lower extremities <br/ ><br>3. Total Cholesterol, Triglycerides, LDL, HDL, S.Creatinine, Hb,ESR, FBS, PPBS and HbA1C levelsTimepoint: 1.Rutherford clinical classification of PAD - 0th, 45th & 61 days <br/ ><br>2. Colour doppler study of arterial system of affected lower extremities - before & after study <br/ ><br>3. Total Cholesterol,Triglycerides, LDL, HDL, S.Creatinine, Hb,ESR, FBS, PPBS and HbA1C levels - 0th & 61 days