| CTRI Number |
CTRI/2013/06/003740 [Registered on: 12/06/2013] Trial Registered Retrospectively |
| Last Modified On: |
04/02/2019 |
| 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 trial to evaluate efficacy and safety of Slimferin tablets in reducing the bodyweight in obese patients. |
|
Scientific Title of Study
|
A Prospective, Randomized, Double blind, Placebo controlled clinical trial to evaluate efficacy and safety of Slimferin tablets in reducing the bodyweight in obese patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/ VH/1129/18 Version 01 Dated 13/12/2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jagadeesh TV BAMS |
| Designation |
Family Physician |
| Affiliation |
Amruth Poly Clinic, |
| Address |
Amruth Poly Clinic,
Near Jana Priya Apartments,
Allalasandra,
Yelahanka, Bangalore – 64
Bangalore
KARNATAKA
560064
India |
| Phone |
9880134660 |
| Fax |
|
| Email |
drjagadeeshtemkar@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Harisha S |
| Designation |
Director-Operations |
| Affiliation |
ICBio Clinical research Pvt Ltd |
| Address |
ICBio Clinical Research Pvt. Ltd. #16, ICBio Tower, Yelahanka Main Road Chikkabetahalli,
Vidyaranyapura,
Bangalore - 560 097
INDIA
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Harisha S |
| Designation |
Director-Operations |
| Affiliation |
ICBio Clinical research Pvt Ltd |
| Address |
ICBio Clinical Research Pvt. Ltd. #16, ICBio Tower, Yelahanka Main Road Chikkabetahalli,
Vidyaranyapura,
Bangalore - 560 097
INDIA
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vidya herbs |
| Address |
#30, 33rd Main
J P Nagar 6th Phase,
Bangalore 560078 India.
Tel: +91 80 4172 2212 / 2653 1133
|
| Type of Sponsor |
Other [Indian 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 Jagadeesh |
Amruth Poly Clinic |
Near Jana Priya Apartments,
Allalasandra,
Yelahanka, Bangalore – 64
Bangalore
KARNATAKA |
9880134660
drjagadeeshtemkar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Twice daily taken orally |
| Intervention |
Slimferin Tablets-Twice daily
|
Composition
Mangifera Indica extract tablets, Twice daily for 2 months taken orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
• Age between 18 and 50 years.
• Able to sign voluntarily informed consent.
• Obese subjects with Body mass index 30 to 40 kg/m2
• Subjects must understand risks and benefits of the protocol
• Willingness to participate in the exercise walking program
• If female, should be negative in pregnancy test. Female of child bearing potential, should agree to follow an acceptable method of birth control for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
• Have a history of major problems such as heart disease, thyroid disease or diabetes in the last five years.
• Any other clinically significant disorder
• Abnormal fibrinogen levels
• Non-obese (BMI <30) & morbidity obese (>40).
• 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
• Have orthopedic joint problems that would be barrier to physical activity such as walking.
• Are currently participating in any weight loss clinical trial.
• Women who are pregnant and nursing mothers
• People with major psychiatric illness
• Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations
|
|
|
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 |
| • Reduction in body weight and BMI |
At Baseline, week 2, 4 and week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Changes in lipid profile (Baseline and Week 8)
• Changes in anthropometric measurements-Waist circumference and waist to hip ratio reduction.
• Quality of life of the subjects (SF-36) before and after.
• Random blood Glucose and Hb1Ac concentration (Baseline and Week 56)
• Incidence and rate of adverse events
• Selected Laboratory Investigations (Hematology & Biochemistry) at baseline and week 8.
|
At baseline and week 8 |
|
|
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)
|
14/01/2013 |
| Date of Study Completion (India) |
19/05/2013 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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 trial to evaluate efficacy and safety of Slimferin tablets in reducing the bodyweight in obese patients.The drug which is been used in the study is a composition of an herbal product called Mangifera Indica. Mangifera Indica is a Mango Peel Extract. The extract contains good amount of pharmacologically active flavonoid, a natural xanthone C-glycoside
Primary objectives: · To evaluate the safety and efficacy of Slimferin for treating obesity in obese patients Secondary objectives: · To evaluate the safety and role of Slimferin in improving the quality of life of the subjects Primary outcomes - Reduction in body weight and BMI (Baseline, Week 2, Week 4 and Week 8)
Secondary outcomes - Changes in lipid profile (Baseline and Week 8)
- Changes in anthropometric measurements-Waist circumference and waist to hip ratio reduction.
- Quality of life of the subjects (SF-36) before and after.
- Random blood Glucose and Hb1Ac concentration (Baseline and Week 56)
- Incidence and rate of adverse events
- Selected Laboratory Investigations (Hematology & Biochemistry) at baseline and week 8.
|