Health Condition 1: T07- Unspecified multiple injuries
Conditions
Interventions
Intervention1: Bromcumin (500 mg) capsule: 1. Bromelain 3000GDU - (mg/Capsules)- 400 mg
2. Curcumin Extract 95%- 75 mg
3. Piperine Extract 95% - 25 mg-
Total Duration- 8 Weeks
Control Intervention1:
Sponsors
Herbal Creations (A Unit of Kumaon Exports Pvt. Ltd.)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female adults aged 18 years or older at the time of screening. 2. Participants presenting with deep, open wounds involving at least the dermis and/or subcutaneous tissue (partial- or full-thickness) without exposed bone, tendon, or joint structures. 3. Wound classified as Clean (CDC Class I) or Clean-Contaminated (CDC Class II), with no clinical evidence of local or systemic infection at the time of screening. 4. Wound bed composed predominantly of viable tissue (red or yellow), with necrotic or black eschar covering less than equal to 10% of the total wound surface area (post-debridement, if applicable). 5. Wound surface area greater than equal to 1 cm and less than equal to 100 cm , measured using manual planimetry at baseline (post debridement, if applicable). 6. Acute wound of less than equal to 4 weeks duration at the time of screening. 7. Wound expected to heal by secondary intention with standard wound care and not requiring surgical reconstruction, flap coverage, or skin grafting during the study period. 8. Adequate local perfusion of the wound area, as determined by investigator clinical assessment, indicating sufficient vascular supply for wound healing. 9. Willingness and ability to comply with all study procedures, visits, and assessments. 10. Ability to provide written informed consent prior to any study-related procedures.
Exclusion criteria
Exclusion criteria: 1. Wounds classified as Contaminated (CDC Class III) or Dirty/Infected (CDC Class IV), or any wound showing clinical signs of infection at screening (e.g., purulent discharge, spreading erythema greater than 2 cm, fluctuance, warmth, malodour, or systemic signs of infection). 2. Wounds with exposed bone, tendon, or joint, or wounds requiring flap coverage, grafting, amputation, or other surgical intervention during the study period. 3. Wounds containing necrotic or black eschar that cannot be adequately debrided to viable tissue prior to randomization. 4. Wounds complicated by foreign bodies, hematoma, active sinus tracts, or communication with deep anatomical structures. 5. Wounds associated with osteomyelitis, abscess formation, or systemic infection requiring antibiotic therapy beyond standard wound care. 6. Ischemic wounds with inadequate perfusion, or any wound judged by the investigator to have insufficient vascular supply for healing. 7. Wounds caused by or associated with malignancy, radiation injury, vasculitis, or autoimmune disorders. 8. Current use of anticoagulant or antiplatelet therapy that increases bleeding risk (including warfarin, direct oral anticoagulants, or equivalent agents). 9. Known bleeding disorders, including haemophilia or clinically significant thrombocytopenia. 10. Known hypersensitivity or allergy to bromelain, pineapple, or other proteolytic enzymes, or history of severe allergic or anaphylactic reactions to these substances. 11. Participants with severe uncontrolled diabetes mellitus, as evidenced by medical history and/or medical records indicating HbA1c greater than 9% within the last 3 months or unstable glycaemic control, which in the opinion of the Investigator is likely to interfere with wound healing, will be excluded. 12. In the absence of HbA1c results within the last 3 months, HbA1c testing may be performed at the discretion of the Principal Investigator in participants with a known history of diabetes mellitus. 13. Participants with a known history or current evidence of clinically significant hepatic or renal impairment, as assessed by medical history, physical examination, Investigator s judgment, and/or clinically significant abnormal laboratory parameters. 14. Severe or uncontrolled cardiovascular, respiratory, immunological, or immunosuppressive disorders that may interfere with study participation or outcomes. 15. Pregnant or lactating women, or women planning pregnancy during the study period. 16. Participation in another interventional clinical trial within 30 days prior to screening or concurrent participation in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain assessment using VAS 2. Local signs of inflammation (Erythema, edema, wound exudate) assessment using the Bates-Jensen Wound Assessment Tool (BWAT) 3. Clinical evaluation of wound temperature and tendernessTimepoint: Baseline and follow-up will be weeks- 2, 4, 6 and 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| A) 1. Wound Surface Area Reduction from baseline to week 2, 4 and 8 weeks using manual planimetry 2) Time to Granulation Tissue Formation: Number of days until greater than equal to 90% granulation coverage 3) Rate of complete wound closure: Proportion of participants achieving complete closure by week 8. 4) Safety assessments: Adverse events, local reactions, bleeding complications at all follow up visits. 5) Laboratory safety tests: Random Blood Sugar (RBS) test (Baseline) CBC, LFT, RFT (Baseline and Week 8) B. Exploratory Endpoint- Change in Serum hs- CRP and ESRTimepoint: A. 1. Baseline and Week- 2, 4 and 8 2. NA 3. Week 8 4. Week 2, 4, 6, 8 5. RBS at Baseline, CBC, LFT, RFT at Baseline and week 8. B. Baseline and week 8 | — |
Countries
India
Contacts
Public ContactMs Meena Dalal
TrialGuna Private Limited
Outcome results
None listed