A clinical evaluation of AHPL/AYTOP/0113 cream in comparison with Framycetin Sulphate cream in patients of acute wounds
- Conditions
- Health Condition 1: null- Acute Wounds
- Registration Number
- CTRI/2014/01/004304
- Lead Sponsor
- Ari Healthcare Pvt Ltd R D Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method