| CTRI Number |
CTRI/2017/06/008903 [Registered on: 22/06/2017] Trial Registered Prospectively |
| Last Modified On: |
26/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to assess the Efficacy and safety of liposomal Curcumin in subjects with metabolic syndrome |
|
Scientific Title of Study
|
A randomized, double blind, controlled clinical trial to assess the Efficacy and safety of liposomal Curcumin compared with Curcumin (non-liposomal) on inflammation in subjects with metabolic syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIAG- CSP-002, version 1.0 dated 20 Mar 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivaraj K K |
| Designation |
General Physician |
| Affiliation |
Pristine Hospital and Research Centre Pvt Ltd. |
| Address |
Pristine Hospital and Research Centre Pvt Ltd.,
877, Modi Hospital Road ,
West of Chord Road IInd stage, Bangalore
Bangalore
KARNATAKA
560086
India |
| Phone |
|
| Fax |
|
| Email |
shivarajkk09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Baburao Vikram |
| Designation |
General Manager |
| Affiliation |
Bio Agile Therapeutics Pvt. Ltd. |
| Address |
Bio Agile Therapeutics Ltd Niran Arcade 563/564 Ground Floor New Bel Road Bangalore INDIA
Bio Agile Therapeutics Ltd
Niran Arcade
563/564 Ground Floor
New Bel Road
Bangalore INDIA
Bangalore
KARNATAKA
560094
India |
| Phone |
9620087715 |
| Fax |
09620087715 |
| Email |
pm@bioagiletherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Chandradhar |
| Designation |
Director |
| Affiliation |
Bio Agile Therapeutics Pvt. Ltd. |
| Address |
Bio Agile Therapeutics Ltd Niran Arcade 563/564 Ground Floor New Bel Road Bangalore INDIA
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
|
Source of Monetary or Material Support
|
| Curesupport BV
Wehryweg 27
Valkenburg a/d Geul |
|
|
Primary Sponsor
|
| Name |
CureSupport |
| Address |
Wehryweg 27
Valkenburg a/d Geul |
| Type of Sponsor |
Other [Nutraceuticals] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivaraj K K |
Pristine Hospital and Research Centre Pvt Ltd. |
877, Modi Hospital Road
West of Chord Road IInd stage-560086
Bangalore
KARNATAKA |
9035209089
shivarajkk09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Pristine Hospital and Research Centre Pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Metabolic syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Curcumin (Non Liposomal Curcumin) |
strength: 100 mg of Curcumin per 5 ml, route: Oral, Frequency: 4 times x 5mL per day; Duration: 6 weeks |
| Intervention |
Liposomal Curcumin |
strength: 100 mg of Curcumin per 5 ml, route: Oral, Frequency: 4 times x 5mL per day; Duration: 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. 18 years of age and above
2. Metabolic abnormalities with or without alcohol consumption and/or smoking
3. Diagnosis of MetS ie. the presence of three or more criteria of the modified National Cholesterol Education Programs Adult Treatment Panel III ( NCEP ATP III):
3.1 Waist circumference 90 cm in men and 80 cm in women
3.2 Hypertriglyceridemia ≥ 150 mg/dl
3.3 High density lipoprotein (HDL) cholesterol 40 mg/dl in males and 50 mg/dl in females
3.4 Blood pressure ≥ 130/85 mm Hg
3.5 Fasting plasma glucose ≥ 110 mg/dl
4.0 Patients willing to provide written informed consent |
|
| ExclusionCriteria |
| Details |
1. Pregnancy or breastfeeding,
2. lack of compliance with the study medication (defined as not using the medication for >1 week),
3. Participation in a concomitant trial,
4. Hypersensitivity to the study medication,
5. Presence of malignancies
6. Impossibility to give informed consent.
7. Intake of drugs or dietary supplements
8. Previous illnesses such as heart attack, cancer or dementia
9. Addiction illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Inflammatory marker C-reactive protein (CRP) at baseline and 6 weeks. |
Inflammatory marker C-reactive protein (CRP) at baseline and 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plasma tumor necrosis factor alpha at baseline and 6 weeks
Plasma interleukine 6 at Baseline and 6 weeks
Body weight, anthropometric assessments,
Biochemistry and lipis profile assessment baseline and 6 weeks
Incidence rates of adverse event and changes in vital signs
Blood Hematology assessment
Quality of life using SF-36 questionnaire |
Baseline (Day 0) and Day 42 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the study is to investigate the liposomal curcumin efficacy and safety on inflammatory markers, lipid profile, blood glucose etc. in patients with metabolic syndrome. Liposomal curcumin product has been encapsulated in
liposomes. Liposomes are small lipid globules that are created naturally when
water is mixed with lecithin, an ingredient of soy beans. Liposomes are readily
absorbed by the body. When Liposomal Cureit curcumin is mixed with lecithin it
is encapsulated by the liposomes. The result is an improved absorption of
curcumin in the blood.
|