| CTRI Number |
CTRI/2015/11/006366 [Registered on: 17/11/2015] Trial Registered Prospectively |
| Last Modified On: |
05/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and Safety of Flabonoid in subjects with Metabolic syndrome |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Parallel Group Clinical Study to evaluate Efficacy and Safety of a Novel herbal composition Flabonoid in subject with metabolic syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GL OCL FN 15 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Kiran Kumar |
| Designation |
Prinncipal Innvestigator |
| Affiliation |
Rajiv Gandhi Institute of Medical Sciences and RIMS Govt General Hospital |
| Address |
Department of Medicine
Rajiv Gandhi Institute of Medical Sciences and RIMS Govt General Hospital
Srikakulam
Andhra pradesh
India
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
91-8179547084 |
| Fax |
91-8942-279033 |
| Email |
rimsresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Sanjib Kumar Panda |
| Designation |
Head Operation |
| Affiliation |
Ocius Life Sciences Pvt Ltd |
| Address |
Ocius Life Sciences Pvt Ltd
No 325
P H Road
Aminjikarai
Chennai
TAMIL NADU
600029
India |
| Phone |
9003580729 |
| Fax |
|
| Email |
sanjib@ociuslife.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sanjib Kumar Panda |
| Designation |
Head Operation |
| Affiliation |
Ocius Life Sciences Pvt Ltd |
| Address |
Ocius Life Sciences Pvt Ltd
No 325
P H Road
Aminjikarai
Chennai
TAMIL NADU
600029
India |
| Phone |
9003580729 |
| Fax |
|
| Email |
sanjib@ociuslife.com |
|
|
Source of Monetary or Material Support
|
| Generix Lifesciences Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Generix Lifesciences Pvt Ltd |
| Address |
1223(12th Floor)Devika Towers 6 Nehru Place New Delhi 110019(India) |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 V Kiran Kumar |
Rajiv Gandhi Institute of Medical Sciences and RIMS Govt General Hospital |
Department of medicine
Srikakulam
ANDHRA PRADESH |
91-8179547084
91-8942-279033
rimsresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional of ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Metabolic Syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Flabonoid |
One capsule Once Daily to be taken orally for 84 Days |
| Comparator Agent |
Placebo |
One capsule Once Daily to be taken orally for 84 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Male or female subjects between 18 to 75 years of age
2 Ability to understand the risks/benefits of the protocol
3 Female subjects of childbearing potential must be using a medically acceptable form of birth control Female subjects of non-childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy
4 Confirmed diagnosis of metabolic syndrome as per ATP-III guidelines
This includes the presence of at least 3 or more of the following 5 factors (As per modified NCEP ATP III guidelines-specific for South Asia)
Including
Abdominal waist circumference > 90(males) >80 cm (females) And
Increased blood pressure (>130/85 Hg)
Serum triglycerides ≥ 150 mg/dL
Serum HDL cholesterol < 40 mg/dL (males) < 50 mg/dL (females)
Elevated fasting blood glucose ≥ 100 mg/dL
5 Subjects agree to maintain the activity dairy
6 If Former smoker (previously smoked ≥10 cigarettes/day for at least 1 year, cessation for at least 6 months
7 Willing to give written informed consent and willing to comply with trial protocol
|
|
| ExclusionCriteria |
| Details |
1 Pregnant or breast feeding women
2 Uncontrolled hypertension and Diabetes
3 Other cardiovascular disease or previous cardiovascular event These include
a history of angina pectoris
b history of heart failure
c Presence of a cardiac pacemaker
d History of myocardial infraction
e Previous revascularization procedure
4 History of cerebrovascular disease including stroke and ischemic attack
5 Subjects having abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of normal elevated Creatinine males > 125 μmol/L females > 110 μmol/L renal insufficiency thyroid or other endocrine disease
6 Currently being treated for cancer (i e chemotherapy radiation therapy)
7 Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent
8 Any other condition that in the opinion of the investigator would adversely affect the subjects ability to complete the study or its measures
9 Patient on any medication which is known to modify signs and other parameters of metabolic syndrome
10 Hypersensitivity to any of the ingredient used in the study supplements
11 Alcohol consumption exceeding the definition of moderate drinking (2 drinks/day for men or 1 drink/day for women)
12 Subjects participated in any investigational study medication within thirty (30) days prior to screening
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change from Baseline to End of the study in Metabolic syndrome symptoms
Blood Pressure
Serum triglycerides
Serum HDL
Abdominal waist circumference
Fasting blood glucose
|
Day 0 Day 28 Day 56 Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from Baseline to End of the study in
Serum LDL
Total Cholesterol
Change in Body weight
Assessment of body composition
Change in Glycosylated haemoglobin ( HbA1c)
|
Day 0 Day 28 Day 56 Day 84 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
17/11/2015 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study under trial is to investigate the efficacy of a novel herbal composition flabonoid which believed to be providing a solution for a condition known as metabolic syndrome. Flabonoid is a plant extract containing natural thrapeutic component known as Glabridin, a major polyphenolic flavonoid of G. glabra. The active igredient present in flabonoid is Kaneka glavonoid, which has different effect on humaan body like anti- oxidative, anti- H. pylori , anti- nephritic, radical scavenging activity, anti diabetic, anti-hypertensive, anti- hyperlipidemia anti-artherosclerotic and anti-obese effect. All these effects are essential to control the disorder called metabolic syndrome. So the aim of this study is to evaluate the clinical effectiveness of the flabonoid versus placebo in patient with metabolic syndrome having age relaxation between 18 to 75 , with satisfying the NCEP ATP III criteria. Enrolled subject will receive either flabonoid or placebo for 84 days.At last the effectiveness of flabonoid will be compared with placebo.
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