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

Efficacy of gugguluthikthaka taila and jaloukavacharana in lower extremity peripheral arterial disease associated with type 2 diabetes mellitus: A Randomized controlled clinical trial. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060496

Enrollment

Registered

2023-12-04

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
1.Rutherford clinical classification of PAD 2. Colour doppler study of arterial system of affected lower extremities 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 2. Colour doppler study of arterial system of affected lower extremities - before & after study 3. Total Cholesterol,Triglycerides, LDL, HDL, S.Creatinine, Hb,ESR, FBS, PPBS and HbA1C levels - 0th & 61 days	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Sreeja Sukesan

Government Ayurveda College, Tripunithura

doctorsreejamd@gmail.com7034115701

Outcome results