Clinical study on Low Intensity Ultrasound in diabetic patients

Evaluation of Efficacy and Safety of ALIMFUS - Airborne Low Intensity Multi Frequency Ultrasound, as an Add-on Therapy to Oral Hypoglycemic Agents (OHAs) in Type II Diabetic Patients through Ambulatory Glucose Monitoring (AGM): Self -controlled cross over study. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045734

Enrollment

Registered

2022-09-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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: Dosage and Treatment Duration: OHAs (daily) + Exposure to low frequency airborne ultrasound for 20 minutes from 6th day onw

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males and non pregnant females suffering from Type 2 Diabetes Mellitus on stable dose of 2-3 OHAs for last 8 weeks. 2. At screening visit, patient should have their HbA1C in range of 7-10%. 3. ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia

Exclusion criteria

Exclusion criteria: 1. Subjects having known history of hepatic or renal disease. 2. Subjects having an active malignancy and tuberculosis. 3. Subjects giving history of significant cardiovascular event 4. Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds requiring treatment. 5. Subjects having a 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. Subjects having skin allergy. 8. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study.

Design outcomes

Primary

Measure	Time frame
1.Percentage change in Glycemic control through evaluation of Time in Range (TIR) 2.Percentage change in Time Below Range (TBW) 3.Percentage change in Time above Range (TAR) 4.Change in daily average blood sugar levels. 5.Change in HbA1c%Timepoint: day 0 to day 14	—

Secondary

Measure	Time frame
1. Changes in hemogram, CRP, Vitamin D, homocysteine and lipid profile 2. Global assessment of overall change by investigator and subject 3. Global assessment of tolerability of ALIMFUS by investigator and subject 4. Assessment of adverse events. Timepoint: day 0 to day 14	—

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research Pvt. Ltd

targetinstitute@yahoo.com9322522252

Outcome results

None listed

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