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CTRI Number  CTRI/2014/08/004901 [Registered on: 21/08/2014] Trial Registered Prospectively
Last Modified On: 01/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Study to check the effectiveness and safety of KiOnutrime-CsG capsules, for weight reduction. 
Scientific Title of Study   A Phase IV, Multicenter, Randomized, Single Blind, Placebo-Controlled clinical study to evaluate the efficacy and safety of KiOnutrime-CsG capsules manufactured by KitoZyme for the treatment of excess weight, weight control. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ECTS/14/001, Version No. 00, Dated 04 JUL 2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  410 to 412, G - Block, Titanium City Centre, 100 Feet Road, Nr. Sachin Tower, Satellite

Ahmadabad
GUJARAT
380015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  410 to 412, G - Block, Titanium City Centre, 100 Feet Road, Nr. Sachin Tower, Satellite


GUJARAT
380015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Public Query
 
Name  Mr Tejas Kothari 
Designation  AGM, Marketing 
Affiliation  Corona Remedies Pvt. Ltd. 
Address  Corona House, "C", Mondeal Business Park, Nr. Gurudwara, S.G. Highway, Thaltej

Ahmadabad
GUJARAT
380059
India 
Phone    
Fax    
Email  tejask@coronaremedies.com  
 
Source of Monetary or Material Support  
Corona remedies & KitoZyme 
 
Primary Sponsor  
Name  Corona Remedies Pvt Ltd 
Address  Corona House, "C", Mondeal Business Park, Nr. Gurudwara, S.G. Highway, Thaltej, Ahmedabad-380059. Gujarat, INDIA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
KitoZyme  Parc Industriel des Hauts-Sarts, Herstal-Belgium 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Padmanabh H Zinzuwadia  DHL Research Centre  1st Floor, Sushri Jasumatiben Shantilal Surti Charitable General Hospital (Run by Thakershy Charitable Trust), Opposite Vimanagar, Near Shivranjani Cross Road, Satellite
Ahmadabad
GUJARAT 
917926741177

drpadmanabh@rediffmail.com 
Dr Ronak Shah  Poojan Multispeciality Hospital  1st Floor, Navnidhi Avenue, Gurukul Road, Subhash Chowk, Memnagar
Ahmadabad
GUJARAT 
09898783040

poojan.research@gmail.com 
Dr Jayesh Trivedi  SAL Hospital  118, 1st floor, SAL Hospital, Opp. Doordarshan Tower, Drive-in Road
Ahmadabad
GUJARAT 
09824076530

drjvtrivedi@rediffmail.com 
Dr Chandrahas P T  Sapthagiri Institute of Medical Sciences and Research Center  No. 15, Chikkasandra, Hesaraghatta Main Road
Bangalore
KARNATAKA 
09980757342

drchandrahas1973@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Rathi Institutional Ethics Committee for Dr Padmanabham H Zinzuwadia  Approved 
Rathi Institutional Ethics Committee for Dr Ronak Shah  Approved 
SAL hospital Institutional Ethics Committee for Dr Jayesh Trivedi  Submittted/Under Review 
Sapthagiri Institute of Medical Science & Rearch Centre Institutional Ethics Committee for Dr Chandrahas PT  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  treatment of excess weight, weight control 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KiOnutrime- CsG capsules  One capsule of KiOnutrime- CsG capsules 15 minutes before breakfast and two capsules of KiOnutrime- CsG capsules 15 minutes before lunch and dinner, each time with a large glass of liquid (water) for 90 days. 
Comparator Agent  Placebo  One capsule of placebo 15 minutes before breakfast and two capsules of placebo 15 minutes before lunch and dinner, each time with a large glass of liquid (water) for 90 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male or female subjects with 18 – 65 years of age (both inclusive).
2.Subject/legally acceptable representative (LAR) of subject willing to sign and date written informed consent to participate in the study. However, if the subject/LAR of subject is illiterate, the impartial witness will sign the ICF.
3.Subjects with BMI of 26 to 35 (both inclusive).
4.Subject has clearly visible fat on intended treatment area(s), which in the investigators opinion, may benefit from the treatment(s).
5.Willingness to comply with the study schedule and procedures. 
 
ExclusionCriteria 
Details  1.Subject has history of surgical procedure(s) in the area of intended treatment in the past 6 months.
2.Subject has history of invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past one year.
3.Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past one month.
4.Subject on stable dose of metformine, pioglitazone or on glucagon-like peptide analogues.
5.Subject has a history of bleeding disorder or is taking any medication that in the investigators opinion may increase the subjects risk of bruising.
6.Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
7. Subjects with the history of allergy to chitosan or other similar molecule.
8. Subject with treatment of fat soluble vitamins and minerals or other dietary aids.
9.Subjects with uncontrolled Diabetes Mellitus (HbA1c > 10%)
10. Subjects with uncontrolled Hypertension ( > 160 / 100 mm Hg)
11. Subjects on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, anticoagulants or any other drugs that may have an influence on the outcome of the study.
12. Subject have inflammatory diseases of the gastrointestinal tract (e.g. acid reflux disease, gastritis, ventricular or duodenal ulcers, Crohn’s disease, ulcerative colitis, diverticulitis), signs of intestinal obstruction (impending or existing mechanical or paralytic ileus), gastroparesis in diabetics with neuropathy, intestinal polyps and existing severe digestive disorders (constipation).
13. Subject is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period, or is breast feeding or in preparations used in the treatment of menopause disorders.
14. Participation in any other clinical trial during last 30 days.
15. Subject is taking or has taken diet pills or supplements within the past 30 days.
16. Alcoholics and/or drug abusers.
17. Smoking or Consumption of tobacco products. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction of body weight on day 45 and 90 versus baseline.  Day 45 to 90  
 
Secondary Outcome  
Outcome  TimePoints 
• Mean change in body fat, muscle mass, bone mass, BMI, visceral Fat.
• Mean change in lipid profile.
• Mean change in HbA1c level
• Change in upper abdominal circumference, hip circumference, waist circumference and waist: hip ratio.
• Change in quality of life – SF-36 scale. 
Day 45 to 90 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   21/08/2014 
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    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   A Phase IV, Multicenter, Randomized, Single Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy And Safety of KiOnutrime-CsG capsules for the treatment of excess weight, weight control. eligible subjects will be enrolled into study as per 2:1 randomization ratios.  Total of 90 male or female subjects will be enrolled in the study. Out of 90 subjects, 60 subjects will be enrolled into treatment group and 30 in placebo group. Subjects should take one capsule of Investigational product (KiOnutrime- CsG capsules) or placebo 15 minutes before breakfast and two capsules of Investigational product (KiOnutrime- CsG capsules) or placebo 15 minutes before lunch and dinner, each time with a large glass of liquid (water) for 90 days. Subjects will be evaluated for physical examinations including vital signs, body weight measurements and upper abdominal circumference, hip circumference, waist circumference and waist:hip ratio, body composition (body fat, muscle mass, bone mass, BMI, visceral fat). Questionnaire for quality of life measurement as per SF-36 scale. Blood sample will also be collected to measure safety parameters HbA1c level, safety parameters (SGPT, SGOT, creatinine and urea) and lipid Profile (TG, HDL, LDL and VLDL).
KiOnutrime-CsG Active ingredient: 500 mg chitosan (biopolymer N-acetyl-D-glucosamine and D-glucosamine) from Aspergillus niger mycelium and other components: magnesium stearate, silica
 
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