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CLINICALLY PROVEN TO HEAL 50% FASTER*
RESULTS: The clinical summary below supports the Theriac claim that over a 7 day period of time,
* Theriac healed wounds 50% faster than triple antibiotic ointment. Conducted in accordance with the Declaration of Helsinki, ICH Guideline E6 for Good clinical practice , the requirement of 21CFR parts 50 and 56.
Trial Design: This was a single center, baseline controlled, double blinded, randomized clinical trial design of 2 week duration utilizing 25 subjects.
01-Natural Wound care Ointment Theriac NS# 5833A 02- Triple antibiotic Ointment Lot # 0819LZ Clinical assessment of Wound Healing: Clinical assessment conducted by expert grader after day 2,4,7,9,11 and 14 days of test material use. Wound healing was based on reepithelization by a predetermine scale based on percentage.
Baseline: (Day 0) Subjects received a 3mm wound on both the left and right arm via a tape stripping method. Test Phase (days 2,4,7,9,11 and 14 ) Subjects reported to testing facility ,dressing were removed and images captured
Statistical Analysis: Within group and between group (Test Material .01 VS Test Material .02) statistical analyses performed using a statistical significance achieved at the 95% Confidence level (p<0.050)
Summary: The between group analysis revealed that test site treated with test material .01 exhibited a statistically significant greater wound healing rate compared to test material .02 at days 2,4,7,9,11,and 14.