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Clinical Trials/CTRI/2019/04/018419
CTRI/2019/04/018419
Completed
Phase 2

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 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: E119- Type 2 diabetes mellitus without complications

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: E119- Type 2 diabetes mellitus without complications
Sponsor
Aquatic Remedies Ltd
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Aquatic Remedies Ltd

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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