Study Title
“A Multicenter, randomized, open label, parallel-group, comparative, prospective clinical study to evaluate the efficacy and safety of polyherbal oil compared with betadine 10% ointment in subjects with diabetic non healing wound.”
Hypothesis
This study was designed to evaluate the efficacy and safety of polyherbal oil in comparison with betadine 10% ointment in subjects suffering from diabetic non-healing wound. The primary objective of this study was to evaluate the efficacy of polyherbal oil in reduction of wound size and granulation in diabetic wound. Secondary Objective was to evaluate the effect of polyherbal oil in reduction of exude type, exudate amount, pain, edema and proliferation of epithelialization and monitor the safety profile of polyherbal oil.
Study Design
It was a Multicenter, randomized, open label, parallel-group, comparative, prospective clinical study to evaluate the efficacy and safety of polyherbal oil compared with betadine 10% ointment in subjects with diabetic non-healing wound.
Method
In the study, patients were randomized in the ratio of 1:1. All the subjects were given treatment for dressing with the topical application of Polyherbal oil ≤ 5ml per application or Betadine 10% ointment depending on wound size once on alternate day as per randomization. The treatment continued for 45 days with periodic follow-up on 9th, 18th, 27th, 36th and 45th day from start of treatment.
Results
The current study showed the Percentage reduction in wound size from baseline to end of study treatment for Polyherbal oil (n=33) and Betadine 10% ointment (n=34) as (-49.65% and -35.65) respectively and Percentage reduction in granulation from baseline to end of study treatment for Polyherbal oil (n=33) and Betadine 10% ointment (n=34) as (-45.61 and
-32.99) respectively. There were 15 clinical adverse events reported (Polyherbal oil: 08, Betadine ointment 10%: 07) which were mild in nature.
Conclusion
Polyherbal oil proved to have marked superiority in all primary and secondary efficacy endpoints and it is safe and efficacious when compared with Betadine ointment 10%.
KEYWORDS
Polyherbal oil, Betadine, Diabetic wound, Ayurveda, Granulation tissue, Diabetic ulcer
