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CTRI Number  CTRI/2012/10/003064 [Registered on: 17/10/2012] Trial Registered Prospectively
Last Modified On: 21/07/2014
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 Enoki Mushroom (Flammulina Velutipes Sing, Chitoglucan Extract) 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 Enoki Mushroom (Flammulina Velutipes Sing, Chitoglucan Extract) on Weight Management in Healthy Volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
LPPL/IV/OW/12 Version No.01 Dated 24 May 2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjib Kumar Panda 
Designation  Asst manager overall trial coordinator 
Affiliation  Laila Pharmaceuticals Pvt Ltd 
Address  No 7, Arudra Street, TS Krishna Nagar, Mogappair, Chennai 600037. Tamilnadu, India

Chennai
TAMIL NADU
600037
India 
Phone  04426565923  
Fax  04426565924  
Email  sanjib@lailapharma.com  
 
Details of Contact Person
Scientific Query  
Name  Somashekara 
Designation  Manager 
Affiliation  Laila Pharmaceuticals Pvt Ltd 
Address  No 7, Arudra Street, TS Krishna Nagar, Mogappair, Chennai 600037. Tamilnadu, India

Chennai
TAMIL NADU
600037
India 
Phone  04426565923  
Fax  04426565924  
Email  somu@lailapharma.com  
 
Details of Contact Person
Public Query  
Name  Sanjib Kumar Panda 
Designation  Asst manager overall trial coordinator 
Affiliation  Laila Pharmaceuticals Pvt Ltd 
Address  No 7, Arudra Street, TS Krishna Nagar, Mogappair, Chennai 600037. Tamilnadu, India

Chennai
TAMIL NADU
600037
India 
Phone  04426565923  
Fax  04426565924  
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, No.7 Arudra Street, T.S Krishna Nagar, Mogappair, Chennai - 600037, Tamilnadu, chennai 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
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, Tamilnadu, India
Madurai
TAMIL NADU 		 0452-2312223
0452-2312227
drvkumaravel@gmail.com 
Dr Sivaramasubramanian Shanmugam  GRAM Clinical Research  Karpagam Hospital, No.100, Vakkil New Street, Simmakkal, Madurai-625001, Tamilnadu, india
Madurai
TAMIL NADU 		 0452-4243614
0452-4353614
arun@gramclin.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
GRAM Ethics Committee, Madurai for Dr.Kumaravel  Approved 
GRAM Ethics Committee,Madurai for Dr.Sivaramasubramaniam  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Over Weight 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chitoglucan  150mg Capsule Twice daily prior to lunch and dinner for 120 days  
Comparator Agent  Placebo  150mg Capsule Twice daily prior to lunch and dinner for 120 days  
 
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 (26-32).
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 (5 days a week, 30 min per day) with the scheduled timing per week during the course of the study
6 Subject agrees to consume a vegetarian/non-vegetarian diet of approximately 2,000 kcal/day (17% protein, 25% Fat and 58% carbohydrate)
Subject should be available for duration of study period (6-8 months)
7 Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue these therapies during this study
8 Subject agrees not to start any new therapies for weight loss during the course of the study
9 Subjects agree to maintain the activity dairy
10 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  Day 0 Day 15 Day 30 Day 60 Day 90 and Day 120 
 
Secondary Outcome  
Outcome  TimePoints 
Change from the baseline to the end of the treatment period in LDL, HDL, VLDL, triglycerides, total cholesterol  Day 0 Day 30 Day 60 and Day 120 
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.
Body-fat composition analysis by DEXA 		 Day 0, Day 60 and Day 120 
 
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 3 
Date of First Enrollment (India)   17/10/2012 
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 enokitake mushroom (chitoglucan extract) in providing a solution to a problem of increasing body weight to the over-weight subjects. Chitoglucan is a plant extract of edible enokitake mushroom (Flammulina velutipes Sing) containing natural therapeutic components (vegetal chitosan, beta-glucan and fatty acid complex). Chitoglucan has an anti-obesity property that is believed to be based on two of its natural components. chitoglucan is a safe and effective means of decreasing body fat and cardiovascular disease risk factors at a much lower dosage than regular crustacean-derived chitosan. The purpose of this study is to assess the clinical effectiveness of chitoglucan extracted from edible enokitake mushrooms versus placebo in over-weight subjects whose BMI falls within the range of 26-32. Enrolled subjects will receive chitoglucan or a placebo as Study medication. 
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