| CTRI Number |
CTRI/2013/08/003891 [Registered on: 12/08/2013] Trial Registered Prospectively |
| Last Modified On: |
17/09/2014 |
| 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 double blind clinical Study to Evaluate Efficacy and Safety of a novel formulation on Weight Management in Healthy Volunteers |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Control Study to Evaluate Efficacy and Safety of a novel formulation on Weight Management in Healthy Volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LPPL/IV/CURLA/13 Version No.01 Dated 28 May 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjib Kumar Panda |
| Designation |
Manager overall trial coordinator |
| Affiliation |
Laila Pharmaceuticals Pvt Ltd |
| Address |
Laila Pharmaceuticals Pvt. Ltd.
C/o LailaNutraceuticals Research Center,
Survey No.181/2, JRD Tata Industrial Estate,
Kanuru, Vijayawada,India
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
04443831333 |
| Fax |
04426540581 |
| Email |
sanjib@lailapharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Somashekara |
| Designation |
Senior manager |
| Affiliation |
Laila Pharmaceuticals Pvt Ltd |
| Address |
Laila Pharmaceuticals Pvt. Ltd.
C/o LailaNutraceuticals Research Center,
Survey No.181/2, JRD Tata Industrial Estate,
Kanuru, Vijayawada,India
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666636666 |
| Fax |
|
| Email |
somu@lailapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjib Kumar Panda |
| Designation |
Manager overall trial coordinator |
| Affiliation |
Laila Pharmaceuticals Pvt Ltd |
| Address |
Laila Pharmaceuticals Pvt. Ltd.
C/o LailaNutraceuticals Research Center,
Survey No.181/2, JRD Tata Industrial Estate,
Kanuru, Vijayawada,India
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
04443831333 |
| Fax |
|
| Email |
sanjib@lailapharma.com |
|
|
Source of Monetary or Material Support
|
| Iovate Health Sciences International Inc. 381 North Service Road West Oakville, ON Canada L6M 0H4 |
|
|
Primary Sponsor
|
| Name |
Iovate Health Sciences International Inc |
| Address |
Iovate Health Sciences International Inc. 381 North Service Road West Oakville, ON Canada L6M 0H4 |
| Type of Sponsor |
Other [Nutritional supplement company ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Laila Pharmaceuticals pvt ltd |
Laila Pharmaceuticals Pvt. Ltd.
C/o LailaNutraceuticals Research Center, Survey No.181/2, JRD Tata Industrial Estate,
Kanuru, Vijayawada-520007, Andhra Pradesh. India
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Kumaravel |
Alpha Hospital & Research Centre |
Institute of Diabetes and Endocrinology, 2-B, Gate Lock road, Mela Anuppannady, Madurai-625009.
Madurai
TAMIL NADU |
0452-2312223
0452-2312227
drvkumaravel@gmail.com |
| Dr Sivarama subramanian Shanmugam |
Karpagam Hospital |
Karpagam Hospital,100,Vakkil New Street, Simmakkal,Madurai-62500l
Madurai
TAMIL NADU |
9843939681
drsivaramasubramanian@gmail.com |
| Dr G Eswar |
R.K.HOSPITAL |
R.K Hospital, # 29-28-73, Dasari Vari street, Surya Rao pet, Vijayawada-520 002
Krishna
ANDHRA PRADESH |
9963302067
rkhospital.satya@gmail.com |
| Dr K Manikyeswara Rao |
Suraksha Health Village |
Suraksha Health Village, 121, SBH complex, Gurunanak Nagar Road, Vijayawada-520008
Krishna
ANDHRA PRADESH |
8662488188
surakshahealthvillage@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Bezawada Central Ethics Committee_Vijayawada_Dr.G.Eswar |
Submittted/Under Review |
| Bezawada Central Ethics Committee_Vijayawada_Dr.K Manikyeswar Rao |
Submittted/Under Review |
| GRAM Ethics Committee_Madurai_Dr.Sivaramasubramanian |
Approved |
| GRAM Ethics Committee_Madurai_Dr.V.Kumaravel |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Over weight |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alpha lipoic acid and Curcumin combination |
one capsule of Curcumin 150 mg and Alpha lipoic acid 400 mg, twice daily before break fast and lunch for 16 weeks |
| Comparator Agent |
Placebo |
one capsule twice daily before break fast and lunch for 16 weeks |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1 Male or female subjects between 21 to 45 years of age
2 Subject with BMI range (28-32)
3 Ability to understand the risks/benefits of the protocol
4 Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera ®, or double-barrier and have a negative pregnancy test at the Screening Visit. Female subjects of non-childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy
5 Willingness to participate in a walking-exercise program of 30 minutes of walking per day, in additional to their currently daily activity routine, during the course of the study.
6 Subject agrees to consume a vegetarian/non-vegetarian dietof approximately 1800 kcal/day (17% protein, 25% Fat and
58% carbohydrate).
7 Subject should be available for duration of study period (6-8 months)
8 Subjects agree to come to site in fasting state for their weight measurement and other laboratory parameters examination in all the scheduled visits.
9 Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue these therapies during this study.
10 Subject agrees not to start any new therapies for weight loss during the course of the study.
11 Subjects willing to go for DEXA analysis during the course of study.
12 Subjects agree to maintain the activity dairy
13 Willing to give written informed consent and willing to comply with trial protocol.
|
|
| ExclusionCriteria |
| Details |
1 Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain
2 Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudogout, Pagets disease, joint fracture, acromegaly, fibromyalgia, Wilsons disease, ochronosi, haemochromatosis, heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis
3 Subjects having history of asthma
4 Subjects having history of cardiovascular diseases
5 Subjects having history of diabetes (Type I or Type II) except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose ≥ 140-199 mg/dl.
6 Subject with hyperuricemia (males 480 µmol/L, females 450 µmol/L)
7 Subjects having thyroid disease
8 Subjects having abnormal liver or kidney function test (ALT or AST 2 times the upper limit of normal; elevated creatinine, male 125 µmol/L, female 110 µmol/L)
9 Subjects having abnormal findings on complete blood count
10 Subjects having history of coagulopathies
11 Subjects with hypertension
12 Subjects with HIV Positive
13 Subjects having history of congestive heart failure
14 Subjects having history high alcohol intake (2 standard drinks per day)
15 Pregnant, breast feeding or planning to become pregnant during the study
16 Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent
17 Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures
18 Subjects participated in any investigational study medication within thirty (30) days prior to screening
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from the baseline to the end of the treatment period in body weight, BMI, Wasit Hip Ratio, Body fat and body composition |
Change from the baseline to the end of the treatment period in body weight, BMI, Wasit Hip Ratio, Body fat and body composition |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from the baseline to the end of the treatment period in LDL, HDL and total cholesterol |
Visit-1,4,5 and 7 |
Change from the baseline to the end of the treatment period in Visual Analog Scale (VAS) and Profile of Mood States-Short Form (POMS-SF) questionnaire.
|
Visit-2,5 and 7 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/08/2013 |
| 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="0"
Months="9"
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
|
The study under trial is to investigate the efficacy of novel formulation containing two Natural bioactive compound curcumin and Alpha lipoic acid which helps in providing a solution to a problem of increasing body weight to the over-weight subjects. Curcumin is a polyphenol extracted from the rhizomes of turmeric (Curcuma longa L). It is known for its beneficial health effects attributed to anti-inflammatory, anti-oxidant and hypolipidemic properties. Alpha lipoic acid is an organo-sulfur compound derived from caprylic acid that acts as a co-factor of mitochondrial enzymes. It is synthesized in the human body, but is also widely distributed in foods and has attracted much interest because of its anti-oxidant effects and therapeutic potential. In several human studies for weight management using curcumin and Alpha lipoic acid has demonstrated to be both safe and effective for long-term use. Body weight, BMI, body composition and Waist hip ratio will be assessed in the present study to check the efficacy of study medication. The purpose of this study is to assess the clinical effectiveness of Alpha lipoic acid in combination with curcumin versus placebo in over-weight subjects whose BMI falls within the range of 28-32. Enrolled subjects will receive alphalipoic acid in combination with curcumin or a placebo as Study medication |