Health Condition 1: L979- Non-pressure chronic ulcer of unspecified part of lower leg
Conditions
Interventions
Intervention1: Habb-e-Musaffi-e-Khoon and Marham Kafoor: 2 tablets(each 250mg) after meals with normal water and dressing of Ulcer with Marham Kafoor under strict aseptic precautions respectively for
Sponsors
Central Council for Research in Unani Medicine CCRUM New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of any gender in the age group of 18-65 years 2. Patients having Non-Healing Cutaneous Ulcer (Diabetic Ulcer and Post-traumatic Ulcer) with the following characteristics: Ulcer of =6 weeks duration despite appropriate wound care Ulcer of Wagner’s Classification Grade-I and II Ulcer that does not require frequent debridement (frequent debridement is defined as debridement of ulcer more than once per week) Number of ulcers: 1-3
Exclusion criteria
Exclusion criteria: 1. Vulnerable groups (Age less than 18 years or more than 65 years, pregnant and lactating women) 2. Wagner’s grade-III, IV and V Ulcer 3. Malignant Ulcer, Ulcer with copious discharge, and Ulcer with Cellulitis or other infection (Syphilitic, Lepromatous and Tuberculous ulcers) 4. Patients receiving anticoagulants, corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy 5. Patients with a known history of severe hepatic/ renal (Serum creatinine more than 3mg/dL)/ cardiovascular/ bleeding disorder, severe anaemia (Hb less than 7 g/dL), Tuberculosis, Hepatitis B and HIV infection 6. Diabetic patients with very poor glycaemic control (HbA1c=9%) or severe hyperglycaemia (RBG more than 240 mg/dL) on standard anti-diabetic treatment 7. Revascularization surgery performed within 8 weeks prior to study entry. 8. Patients having any other medical/surgical condition considered unsuitable by the Investigator 9. Patients with a known hypersensitivity to the test drug or any of its ingredients 10. Alcoholics/ Drug Addicts 11. Patients not willing to follow up and complete treatment as per protocol 12. Patients not willing to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of test drug will be assessed on the basis of Ulcer Healing Process on Bates-Jensen Wound Assessment Tool (BWAT)Timepoint: At every week for 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examinationTimepoint: At baseline and at the end of treatment i.e. 06 weeks | — |
Countries
India
Contacts
Public ContactDr Pradeep Kumar
Central Council for Research in Unani Medicine (CCRUM)
Outcome results
None listed