| CTRI Number |
CTRI/2014/05/004635 [Registered on: 29/05/2014] Trial Registered Retrospectively |
| Last Modified On: |
31/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GREEN SLIM IN PATIENTS WITH OBESITY, DIABETES AND HIGH CHOLESTEROL |
|
Scientific Title of Study
|
A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GREEN SLIM IN PATIENTS WITH OBESITY, DIABETES AND HIGH CHOLESTEROL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No: ICBio/CR/GC/0214/36 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Venkateshwarlu BAMS MD Ayurveda |
| Designation |
Family Physician |
| Affiliation |
ANASUYA AYURVEDIC CLINIC |
| Address |
ANASUYA AYURVEDIC CLINIC
Healthcare from Ayurveda
#366/A,
Opp.Nanda Gokula/Mediplus,
50 Ft road,
Hanumanthanagar,Bangalore
Bangalore
KARNATAKA
560050
India |
| Phone |
|
| Fax |
|
| Email |
drvenkatesh64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha S |
| Designation |
Director-Operations |
| Affiliation |
ICBio Clinical research Pvt Ltd |
| Address |
ICBio Clinical Research Pvt.Ltd.
#16,
ICBioTower,
Chikkabettahalli,
Yelhanka Main Road,Vidyaranyapura Post,Bangalore.
Bangalore
KARNATAKA
560097
India |
| Phone |
|
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha S |
| Designation |
Director-Operations |
| Affiliation |
ICBio Clinical research Pvt Ltd |
| Address |
ICBio Clinical Research Pvt.Ltd.
#16,
ICBioTower,
Chikkabettahalli,
Yelhanka Main Road,Vidyaranyapura Post,Bangalore.
Bangalore
KARNATAKA
560097
India |
| Phone |
|
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Green Chem
5-BDA, 2nd stage,
3rdphase, Domlur Village,
Bangalore,Karnataka 560071
|
|
|
Primary Sponsor
|
| Name |
Green Chem |
| Address |
5-BDA, 2nd stage, 3rd phase,
Domlur Village,
Bangalore,
Karnataka 560071
|
| Type of Sponsor |
Other [Other [Herbal Company]] |
|
|
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 K Venkateshwarlu BAMS MD Ayurveda |
ANASUYA AYURVEDIC CLINIC |
#366/A,Opp.Nanda Gokula/Mediplus,
50 Ft Road,Hanumanthanagar,Bangalore-560050
Bangalore
KARNATAKA |
9945232107
drvenkatesh64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical IEC Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E65-E68||Overweight, obesity and other hyperalimentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
green slim |
4 lozenges a day- two in the morning & two in the night before food for 112 days |
| Comparator Agent |
Placebo |
4 lozenges a day- two in the morning & two in the night before food for 112 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Male and female subjects aged 18 to 60 years
• Obese subjects with Body mass index 25 to 35 kg/m2
• Diabetic subjects with HbA1C ≥ 7%
• Moderately elevated Total serum cholesterol level
• Subjects must understand risks and benefits of the protocol and be able to give informed consent along with audio video visual
• Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result
|
|
| ExclusionCriteria |
| Details |
• Any other clinically significant disorder
• Have a history of hypertension, Angina, stroke, thyroid diseases
• Presently using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss
• Recent, unexplained weight loss or gain
• History of HIV positive patients
• History of hepatitis, pancreatitis, lactic acidosis or hepatomegaly with steatosis.
• History of motor weakness or peripheral sensory neuropathy
• Are currently participating in any clinical trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes
• Reduction in body weight and BMI, from Baseline to End of treatment
• Changes in lipid profile, blood glucose levels & HbA1C
• Changes in Waist circumference (anthropometric measurements)
• Changes in CRP, Cortisol & Liver enzymes.
• Changes in body fat percentage and lean muscle/body mass percentage
Secondary outcomes
• Safety and Tolerability assessed by Adverse Events
• Subject QOL questionnaire
|
At Screening ,day 112
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes
•Safety and Tolerability assessed by Adverse Events
•Subject QOL |
At Screening ,day 112 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2014 |
| Date of Study Completion (India) |
05/12/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
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 Prospective, Randomized, Double blind, Placebo controlled, clinical Study to evaluate the Efficacy and Safety of GREEN
SLIM in patients with Obesity,
Diabetes and High Cholesterol Primary outcomes
·
Reduction in body
weight and BMI, from Baseline to End of treatment
·
Changes in lipid profile, blood
glucose levels & HbA1C
·
Changes in Waist circumference (anthropometric
measurements)
·
Changes in CRP, Cortisol & Liver
enzymes.
·
Changes in body fat percentage and
lean muscle/body mass percentage
Secondary outcomes
·
Safety and Tolerability assessed by
Adverse Events,Subject QOL questionnaire
Drug Composition Green Slim which contains CARALLUMA FIMBRIATA List of excipients The key constituents of Caralluma fimbriata are pregnane
glycosides, saponin glycosides, and bitter principles Extract Solvents Used: Ethyl
alcohol
Excipients: 10% Maltodextrin
maximum
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