A Randomized, Open Labeled, Multi-center, Prospective, Comparative Clinical Study to evaluate efficacy and safety of Topical Herbal Sprays on Non Healing Ulcers â?? Diabetic Foot Ulcers & Varicose Ulcers - NI

Millennium Herbal Care Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

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•1. Patients having either Type I or Type II Diabetes with non-healing Diabetic Foot Ulcers or patients having non-healing Varicose Ulcers with or without Diabetes
•2. Diabetic patients having HbA1C < 8.
•3. Patients having either Diabetic Foot Ulcer or Varicose Ulcers with the following Ulcer characteristics :
•a. Neuropathic and mild Neuro-ischaemic
•Diabetic Foot Ulcer (Single or multiple ulcers)
•b. Diabetic Foot ulcers with Grade 1 to 2
•(Wagenerâ??s classification)(Appendix B)
•c. Non-Healing Varicose Ulcers
•d. Duration of ulcer more than 1 month
•e. Surface area of the Non-Healing Ulcer
•between 1 cm2 to 25 cm2
•5. Patients willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

•1) Patients with ischemic Ulcers (Diagnosed Clinically and/or with Doppler)
•2. Known cases of Severe/Chronic Hepatic or Renal disease.
•3. Known cases of any active malignancy.
•4. Patients giving history of significant cardiovascular event < 12 weeks prior to randomization.
•5) Chronic alcoholics / Alcohol Abuse.
•6) Patients ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
•7) Patients X- ray chest showing any active lesion of tuberculosis.
•8) Patients having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV.
•9)Patients using any other investigational drug within 1 month prior to recruitment.
•10) Known hypersensitivity to any of the ingredients used in study drug.
•11) Pregnant and Lactating females.
•12) Patients currently participating in any other Clinical study or any education treatment program for Ulcers.
•13) Patients having any other medical or surgical condition considered unsuitable for his/her participation in the study as per Investigatorâ??s judgment.
•14) Patients receiving drugs which may interact with the study therapeutic protocol such as glucocorticoids, immunosuppressive and cytotoxic drugs.
•15) Patients who have undergone ulcer treatments with cell therapy, dermal substitutes, or other biological therapies within the last 30 days.

发起方

Millennium Herbal Care Ltd