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Kungiliya Seelai(Medicated Plaster) in the management of Madhumega Viranam (Diabetic Foot Ulcer)

PHASE II NON RANDOMISED OPEN CLINICAL EVALUATION ON EFFICACY OF KUNGILIYA SEELAI (MEDICATED PLASTER) IN THE MANAGEMENT OF MADHUMEGA VIRANAM (DIABETIC FOOT ULCER)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048566
Enrollment
30
Registered
2022-12-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: L975- Non-pressure chronic ulcer of other part of foot Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Kungiliya Seelai (Medicated plaster) in the management of Madhumega Viranam (diabetic foot ulcer): External application, treatment duration-alternative days for 6 weeks, procedure durat

Sponsors

Government Siddha Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Known case of diabetes mellitus type 2 Ulcer with Wagnerâ??s Grade 1 or 2 HbA1c Patient has adequate circulation to the foot as evidenced by a palpable pulse. Willing to participate in trial and signing consent by fulfulling the condition of Proforma. Patient who are taking standard special OPD medicine for diabetes in AAGHIM

Exclusion criteria

Exclusion criteria: Abscess or Osteomyelitis formation Diabetic ulcer with loss of pulsation Extensive and localised gangrene which requires amputation Patients taking blood thinners like aspirin and clopidogrel Anaemia with Hb less than 10g/L Current treatment for any malignancy or neopastic disease Patient has a highly communicable disease Serum creatine level >110umol/L HbA1c >9% Varicose and Traumatic ulcers Arterial ulcer Tuberculous ulcer Lepromatous ulcer Immuno-suppressive patients Any other systemic illness -will be excluded clinically or based on available medical reports

Design outcomes

Primary

MeasureTime frame
reduction in size, depth and appearance of the ulcer with LEG ULCER MEASUREMENT TOOL(LUMT)Timepoint: 6 weeks

Secondary

MeasureTime frame
Establish a clinical evidence to increase the value of Siddha external therapeutic procedure in ulcers by examining before and after treatmentTimepoint: 6 weeks

Countries

India

Contacts

Public ContactDr G SEKAR

Goverment Siddha Medical College, Chennai

drsekarg@gmail.com7010314542

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026