| 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
|
|
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
|