Clinical study on Airborne Low Intensity Multi frequency Ultrasound in Type 2 Diabetic Patients

Phase 2

Completed

Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

Registration Number: CTRI/2019/04/018419

Lead Sponsor: Aquatic Remedies Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To compare change in QOL (diabetes) over three months of the study treatment between the groups <br/ ><br>2. To compare change in HbA1C% (Glycosylated Hemoglobin) value between the groups (Before and after treatment). <br/ ><br>Timepoint: Day -7, Day 0, Day 30, Day 60, Day 90

Secondary Outcome Measures

Name	Time	Method
1. Monthly changes in FBS and PPBS. <br/ ><br>2. Monthly changes in the clinical symptoms of DM <br/ ><br>3. Change in HOMA IR score <br/ ><br>4. Change in fasting serum Insulin <br/ ><br>5. Monthly change in dose and type of OHAs <br/ ><br>6. Monthly changes in weight, BMI, waist circumference etc <br/ ><br>7. Change in Hs-CRP, Interleukin-6, TNF-Î±, Homocysteine, Vitamin D, Serum Leptin, Serum Adiponectin <br/ ><br>8. Tolerability of study treatments <br/ ><br>9. Laboratory investigations and vitals <br/ ><br>Timepoint: Day -7, Day 0, Day 30, Day 60, Day 90