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

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 - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018419

Enrollment

100

Registered

2019-04-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Airborne Low Intensity Multi frequency Ultrasound instrument: Airborne Low Intensity Multi frequency Ultrasound instrument that emits sound energy by using the quartz crystal technology

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research

targetinstitute@yahoo.com9322522252

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026