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CTRI Number  CTRI/2019/04/018419 [Registered on: 04/04/2019] Trial Registered Prospectively
Last Modified On: 14/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study on Airborne Low Intensity Multi frequency Ultrasound in Type 2 Diabetic Patients 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
GLUCOSTIM/DM /2019, Version 1.0, 4th Feb 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vyankatesh K Shivane 
Designation  Chief Diabetologist  
Affiliation  Sadhana Diabesity Clinic 
Address  Sadhana Diabesity Clinic B-6 New Bhavana Building, SVS Rd, Above Rajashree Productions & Marshalls Showroom, Prabhadevi, Mumbai

Mumbai
MAHARASHTRA
400025
India 
Phone  9820084780   
Fax    
Email  drvkshivane@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Tamoli 
Designation  Director  
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400064
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Tamoli 
Designation  Director  
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai


MAHARASHTRA
400064
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Source of Monetary or Material Support  
Aquatic Remedies Ltd. 1208-1211, Cabin B, 12th Floor, Universal Majestic, P.L. Lokhande Marg, Behind RBK International School, Ghatkopar-Mankhurd Link Road,Chembur (W), Mumbai 400043 
 
Primary Sponsor  
Name  Aquatic Remedies Ltd 
Address  1208-1211, Cabin B, 12th Floor, Universal Majestic, P.L. Lokhande Marg, Behind RBK International School, Ghatkopar-Mankhurd Link Road,Chembur (W), Mumbai 400043  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pranita Joshi Deshmukh  MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra Malwadi Hadapsar Pune  Department of Kayachikitsa, OPD No.1, Ground Floor MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028
Pune
MAHARASHTRA 		 9822229579

pranitaj@gmail.com 
Dr Raman Ghungarlekar  R A Podar Medical College (Ayu) & M.A. Podar Hospital Worli, Mumbai  OPD No 16, Ground Floor, Department of Kayachikitsa, R A Podar Medical College (Ayu) & M.A. Podar Hospital Worli, Mumbai, Maharashtra
Mumbai
MAHARASHTRA 		 9221100630

ghungralekar@gmail.com 
Dr Vyankatesh K Shivane   Sadhana Diabesity Clinic   OPD Department, Room No.1, B-6 New Bhavana Building, SVS Rd, Above Rajashree Productions & Marshalls Showroom, Prabhadevi, Mumbai, Maharashtra 400025
Mumbai
MAHARASHTRA 		 9820084780

drvkshivane@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee R A Podar Medical College (Ayu) & M.A. Podar Hospital Worli, Mumbai, Maharashtra  Approved 
Institutional Review Board For Research, MAMs SS Ayurveda Mahavidyalaya & Sane Guruji Aarogya Kendra, Malwadi, Hadapsar, Pune, 411028  Approved 
Inter System Biomedica Ethics Committee, c/o Kasturba Health Society, Sthanakwasi Jain Aradhana Dham, Khandubhai Desai Road, Vile Parle (West), Mumbai, Maharashtra 400056  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Airborne Low Intensity Multi frequency Ultrasound instrument  Airborne Low Intensity Multi frequency Ultrasound instrument that emits sound energy by using the quartz crystal technology. Frequency range of ALIMFUS is between 20 Khz to 65 Khz. Airborne Low Intensity Multi frequency Ultrasound instrument works on thermal and non-thermal principle of ultrasound physics known as Cavitations, Acoustic streaming, Sonoporation and sonophoresis. Dosage and Treatment Duration: OHAs (daily) + Exposure to low frequency airborne ultrasound for 10 minutes (alternate day) for 3 months  
Comparator Agent  Matching Placebo device not emitting any sound waves   Matching Placebo device not emitting any sound waves Dosage and Treatment Duration: OHAs (daily) + Exposure to placebo device not emitting any sound waves for 10 minutes (alternate day) for 3 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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).
 		 Day -7, Day 0, Day 30, Day 60, Day 90  
 
Secondary Outcome  
Outcome  TimePoints 
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-α, Homocysteine, Vitamin D, Serum Leptin, Serum Adiponectin
8. Tolerability of study treatments
9. Laboratory investigations and vitals
 		 Day -7, Day 0, Day 30, Day 60, Day 90  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   08/04/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   It is 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. The study will be conducted at three sites in India. As per computer generated randomization list, Subjects will be randomized to either of the two groups i.e. OHAs (daily) + Exposure to low frequency airborne ultrasound for 10 minutes (alternate day) for 3 months or OHAs (daily) + Exposure to placebo waves for 10 minutes (alternate day) for 3 months. The primary objectives of the study will be to compare change in QOL (diabetes) over three months of the study treatment between the groups and to compare change in HbA1C% (Glycosylated Hemoglobin) value between the groups (Before and after treatment). The secondary objectives of the study will be to compare monthly changes in fasting and postprandial plasma glucose levels over three months of study treatment between the groups,.monthly assessment of changes in the clinical symptoms of Diabetes Mellitus (Poly urea, Polyphagia, Polydipsia and Fatigue), to compare change in HOMA IR score between the two groups (Before and after treatment), to compare change in fasting serum Insulin level between the groups (Before and after treatment), to compare monthly change in dose and type of OHAs between the groups, to compare monthly changes in weight, BMI, waist circumference, Hip Circumference, waist: Hip ratio Basal Metabolic Rate (BMR), Body fat percentage (Instrumental evaluation), total body water, lean body mass (LBM), Neck circumference, Upper mid arm circumference, calf circumference between the groups, to compare change in Hs-CRP, Interleukin-6, TNF-α, Homocysteine, Vitamin D, Serum Leptin, Serum Adiponectin between the groups (before and after treatment) and to assess tolerability of study treatments by assessing ADRs and assessment of safety laboratory investigations.  
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