Health Condition 1: T148- Other injury of unspecified body region
Conditions
Interventions
None listed
Sponsors
Dvija Naturals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects who are able to understand instructions and willing to give written informed consent and comply with study protocol. 2. Subjects who agree to have their wound photographed for trial. 3. Subjects with wounds caused by trauma/ Burns (localized burns), Diabetic foot, bed sores, other co- morbid condition, post-operative wound etc. (within 7 days of occurrence) 4. Subjects with superficial and partial thickness wound. 5. Wound size of less than 49 square centimetre. 6. The subject is willing to complete all follow-up evaluations required by the study protocol
Exclusion criteria
Exclusion criteria: 1. Subjects having a known hypersensitivity to any of the trial medicines or their components. 2. Subjects who have received treatment (another investigational agent) within last thirty days from Screening or Baseline Visit. 3. Subjects are not willing to give informed consent. 4. Pregnant and lactating women. 5. Pediatric subjects. 6. Subjects having clinical evidence of moderate to severe bacterial or fungal infection of the wound as per visual or clinical assessment. 7. Subjects with wound requiring closure by suturing, etc. and or dressing, in the opinion of Investigator or Coinvestigator. 8. Subjects on any other conservative treatment which influences the study results. 9. Subjects with any underlying serious medical illness. 10. Immunocompromised and non- cooperative subjects and or known history of HIV AIDS. 11. Subjects with full thickness wound beyond subcutaneous layer. 12. Subjects with known immunological, hematologic disorders or metastatic malignancy. 13. Subjects having known neurological or psychiatric pathologies. 14. Subjects who have received chemotherapy or radiation therapy within the past 5 years. 15. Subject, who has used any kind of medicines local application and or oral medication for wound within 6 hours prior to Screening or Baseline Visit. 16. Subjects on NSAIDs. 17. Subjects who have received treatment with glucocorticoids for more than 10 consecutive days within 6 months prior to screening or baseline visit or oral corticosteroid with dose more than 10mg per day. 18. Subjects on systemic or topical antibiotics or systemic therapy with cytotoxic drugs. 19. Subjects having severe edema on the treatment target part.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of the Investigational Product will be evaluated using Bates-Jensen Wound Assessment Tool (BJWAT)Timepoint: Baseline, Day 2, Day 4, Day 7, Day 10, Day 14, Day 17 and Day 21 or the Day of complete healing of wound (whichever is earlier). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Surface area of wound 2. Different parameters of wound assessment as components of Bates-Jensen Wound Assessment Tool (BJWAT) 3. Visual assessment scale (VAS)Timepoint: Baseline, Day 2, Day 4, Day 7, Day 10, Day 14, Day 17 and Day 21 or the Day of complete healing of wound (whichever is earlier). | — |
Countries
India
Contacts
Public ContactDr Shailesh Jaiswal
Parul Institute of Ayurved
Outcome results
None listed