| CTRI Number |
CTRI/2022/03/040987 [Registered on: 10/03/2022] Trial Registered Prospectively |
| Last Modified On: |
08/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
This is a study to evaluate the efficacy and safety of Slimilyn® Capsules verses placebo in overweight and obese adult subjects. |
|
Scientific Title of Study
|
A double-blind, randomised, placebo controlled, parallel study to evaluate the efficacy of Slimilyn® Capsules in weight loss and to evaluate its safety in overweight and obese adult subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| iVRS-CD-20-010 Version 01 Dated 03 Feb 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MEGHANA MURTHY |
| Designation |
Principal Investigator |
| Affiliation |
Narayana Super Speciality Hospitals |
| Address |
General Medicine Department Room No 03 Ground floor No 6 7 and 8 18th Cross 4th Main Malleshwaram West
Bangalore
KARNATAKA
560055
India |
| Phone |
7259214727 |
| Fax |
|
| Email |
meggydoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Channabasavanna G Halasagi |
| Designation |
Medical Monitor |
| Affiliation |
In Vitro Research Solutions Pvt. Ltd. |
| Address |
No 22 and 23 Kodigehalli Main Road Sahakar Nagar Hebbal
Bengaluru 560092 KARNATAKA India
Bangalore
KARNATAKA
560092
India |
| Phone |
6366947473 |
| Fax |
|
| Email |
channa@ivrs.org.in |
|
Details of Contact Person
Public Query
|
| Name |
T Vijay Bhaskar |
| Designation |
Director - Clinical Development |
| Affiliation |
In Vitro Research Solutions Pvt. Ltd. |
| Address |
No 22 and 23 Kodigehalli Main Road Sahakar Nagar Hebbal
Bengaluru 560092 KARNATAKA India
Bangalore
KARNATAKA
560092
India |
| Phone |
636675282 |
| Fax |
|
| Email |
vijay@ivrs.org.in |
|
|
Source of Monetary or Material Support
|
| Narayana Super Speciality Hospitals 6 7 and 8 18th Cross 4th Main Malleshwaram West Bengaluru 560055 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Herbalyn Lifesciences Inc |
| Address |
Bayside Technology Park 46500 Fremont Blvd#706 Fremont, CA
94538, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| In Vitro Research Solutions iVRS Pvt Ltd |
22 & 23, Kodigehalli Main Road, Sahakar Nagar, Hebbal, Bengaluru. India. 560092 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MEGHANA MURTHY |
Narayana Super Speciality Hospitals |
General Medicine Department Room No 03 Ground floor No 6 7 and 8 18th Cross 4th Main Malleshwaram West
Bangalore
KARNATAKA |
7259214727
meggydoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vagus Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Slimilyn (Herbal Supplement), Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 200(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: NA |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. Adult males and non-pregnant females aged 18 to 60 years.
b. Have a BMI of 25.0 kg/m2and above, along with body fat of >25%.
c. Stable body weight during the previous 3 months (less than 5 kg self-reported weight change)
d. Not one of the following eating disorders by subjects declaration anorexia nervosa, bulimia nervosa.
e. Generally considered healthy according to medical history, physical examination, electrocardiogram (ECG), and laboratory evaluation with a special emphasis on metabolic parameters (fasting glucose concentration < 100 mg, normal blood pressure) as per principal investigator’s judgment.
f. Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
g. Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study. |
|
| ExclusionCriteria |
| Details |
a. Diagnosis of type 1 or type 2 diabetes
b. Visit 1 thyroid-stimulating hormone (TSH) outside of the range of 0.4- 4.5
μIU/mL
c. History of chronic pancreatitis or idiopathic acute pancreatitis and other
chronic gastroenterological disease
d. Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome)
e. Current or history of treatment with medications that may cause significant
weight gain for at least 3 months before this trial
f. Current participation in an organized diet reduction program (or within the
last 3 months)
g. Previous surgical treatment for obesity (excluding liposuction if performed
more than one year before trial)
h. Subjects on prescription and non-prescription appetite or weight modifying
drugs including herbal products
i. Used of any investigational drug or device during the study or within 30
days prior to 1st dosing of study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in body weight from baseline to end of the treatment (Day 90) (along with the percentage of participants who achieve a minimum of 10% weight loss |
day 0 to day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Change in Body Fat, Waist Circumference and Body Mass Index (BMI) From
Baseline to end of the treatment (Day 90)
• Change in lipid profile From Baseline to end of the treatment (Day 90)
• Change from Baseline for Obesity Weight Loss Quality of Life Instrument
(OWL-QoL) and Weight-Related Symptom Measure (WRSM).
• Treatment-emergent adverse events (including laboratory abnormality) |
day 0 to day 90 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/03/2022 |
| Date of Study Completion (India) |
20/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Overweight and obesity are growing health problems all over the world. It is a direct result of food-intake in excess of body energy expenditure. An alternative strategy for the induction of increased energy expenditure is via the activation of thermogenic cells that utilize fat to produce heat with the help of herbal supplements. It is a safe and cost-effective method of weight reduction for many overweight and obese individuals. Slimilyn consists of various herbal extracts in combination with minerals and amino acids. As per pre-clinical and clinical studies reported earlier, it was found to be safe for consumption. It has been postulated, Slimilyn helps in the management of weight loss. This is a double blind, randomized, placebo controlled clinical trial for the evaluation of weight loss, safety, and tolerability of Slimilyn® in overweight and obese volunteers. |