Health Condition 1: null- Acute Wounds
Conditions
Interventions
Intervention1: AHPL/AYTOP/0113: Each gm of cream contains % of ingredients (w/w)
Jatyadi Taila (Classical Ayurvedic Medicine) Ashvattha Extract (Ficus religiosa) Nyagrodha Extract (Ficus bengalensis)
Sponsors
Ari Healthcare Pvt Ltd R D Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects that agree to have their wound photographed for the trial. 2. Healthy male and female subjects of 18 to 50 years of age. 3. Subjects having acute wounds (less than 6 hours of occurrence). 4. Subjects with partial or full thickness skin wounds between greater than or equal to 1.0 and less than or equal to 16.0 cm² area 5. Subjects ready to take injection TT before application of study drug. 6. Subjects are willing to make all required study visits. 7. Subjects are willing to follow instructions in the opinion of the Investigator.
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 (30) days from Screening/Baseline Visit. 3. Pregnant and lactating women. 4. Women with child bearing age and who refuse to use effective contraceptive methods. 5. Subjects having clinical evidence of moderate to severe bacterial or fungal infection of the wound as per visual/clinical assessment. 6. Conditions that would interfere with wound healing (diabetes and hypertension). 7. In the opinion of Investigator/Co-investigator, there is need of wound closure (by suturing, etc.) and/or dressing of wound. 8. Subject, who has used any kind of medicines (local application and/or oral medication) for wound within 6 hours prior to Screening/Baseline Visit. 9. Subjects with known immunological, hematologic disorders or metastatic malignancy. 10. Subjects having known neurological or psychiatric pathologies. 11. Subjects who have received chemotherapy or radiation therapy within the past 5 years. 12. Subjects on NSAIDs. 13. For pain management patients will be advised to take only tablet paracetamol up to 2 gm/day. 14. Subjects who have received treatment with glucocorticoids for > 10 consecutive days within 6 months prior to screening/baseline visit. 15. Subjects on systemic or topical antibiotics or systemic therapy with cytotoxic drugs. 16. Subjects having severe edema on the treatment/target part. 17. Subjects with known history of HIV/AIDS. 18. Alcoholic and Smoker.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of time required (in days) for complete wound healingTimepoint: Day 0, 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.Comparison of surface area of acute wounds 2.Evaluation of Wound healing process i.e.Depth of Wound,Wound Edges,Presence of exudates,Appearance of Skin around the wound, Peripheral tissue swelling, edema, Granulation of Wound, Epithelialization 3.Pain Assessment on VAS 4.Assessment of Adverse Events 5.Assessment of drug compliance 6. Treatment tolerability by patient and physician 7.Global evaluation for overall improvement by physician and by the patientTimepoint: For 1st to 5th outcomes Day 0, 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) For outcomes 6th and 7th Day 0 and Day 21 or the Day of complete healing of wound (whichever is earlier) For objectives 1st to 5th:Day 0, 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 Sanjay Nipanikar
Ari Healthcare Pvt. Ltd, R & D Centre
Outcome results
None listed