A Randomized, multi-center, Double Blind, Interventional, Placebo Controlled Study To Evaluate Efficacy and Safety of ALIMFUS - Airborne Low Intensity Multi frequency Ultrasound, as an Add-on therapy to Oral Hypoglycemic Agent (OHA) in Type II Diabetic Patients - NI

Aquatic Remedies 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

试验速览

暂无简介。

•1.Subjects suffering from 2 Diabetes Mellitus on regular diet and mono or poly drug anti-diabetic therapy
•2.At screening visit, patient should have their HbA1C in range of 7-10 percent
•3.ECG not demonstrating any signs of uncontrolled arrhythmia or acute ischemia.
•4.Subjects voluntarily signing informed consent form and willing to follow the procedures as per the study protocol.

•1. Subjects having known hepatic or renal disease
•2. Subjects having an active malignancy and tuberculosis
•3. Subjects giving history of significant cardiovascular event less than 12 weeks prior to randomization.
•4. Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy and Diabetic wounds requiring treatment.
•5. Subjects having chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
•6. Use of any other investigational drug within 1 month prior to randomization
•7. Known hypersensitivity to ultra sound.
•8. Pregnant and Lactating females.
•9. Subjects having skin allergy
•10. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria

发起方

Aquatic Remedies Ltd