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CTRI Number  CTRI/2013/02/003348 [Registered on: 05/02/2013] 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 Randomized, Double-blind, Placebo-Controlled trial to Assess the Efficacy and Tolerability of UC-II® in Modulating Knee Joint Function  
Scientific Title of Study   A Randomized, Double-blind, Placebo-Controlled trial to Assess the Efficacy and Tolerability of UC-II® in Modulating Knee Joint Function as Measured by Levels of Serum and Synovial Fluid Biomarkers 
Secondary IDs if Any  
Secondary ID  Identifier 
LPPL/IH/OA/002/12,Version no.2.0 Dated: 30 Oct 2012   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjib Kumar Panda 
Designation  Overall Trial Coordinator  
Affiliation  Laila Pharmaceuticals Pvt Ltd 
Address  Laila Pharmaceuticals Pvt Ltd No 7, Arudra Street, TS Krishna Nagar, Mogappair, Chennai

Chennai
TAMIL NADU
600 037
India 
Phone  04426565923  
Fax  04426565924  
Email  sanjib@lailapharma.com  
 
Details of Contact Person
Scientific Query
 
Name  Somashekara  
Designation  Manager R & D 
Affiliation  Laila Pharmaceuticals Pvt Ltd 
Address  Laila Pharmaceuticals Pvt Ltd No 7, Arudra Street, TS Krishna Nagar, Mogappair, Chennai

Chennai
TAMIL NADU
600 037
India 
Phone  04426565923  
Fax  04426565924  
Email  somu@lailapharma.com  
 
Details of Contact Person
Public Query
 
Name  Sanjib Kumar Panda 
Designation  Overall Trial Coordinator  
Affiliation  Laila Pharmaceuticals Pvt Ltd 
Address  Laila Pharmaceuticals Pvt Ltd No 7, Arudra Street, TS Krishna Nagar, Mogappair, Chennai

Chennai
TAMIL NADU
600 037
India 
Phone  04426565923  
Fax  04426565924  
Email  sanjib@lailapharma.com  
 
Source of Monetary or Material Support  
InterHealth Nutraceuticals 5451 Industrial Way Benicia, California 94510 
 
Primary Sponsor  
Name  InterHealth Nutraceuticals 
Address  5451 Industrial Way Benicia, California 94510 
Type of Sponsor  Other [Nutraceutical Company] 
 
Details of Secondary Sponsor  
Name  Address 
Laila Pharmaceuticals Pvt Ltd  No 7, Arudra Street, TS Krishna Nagar, Mogappair, Chennai 600 037 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Balakondiah  Bollineni Superspeciality Hospital   Dargamitta,Nellore
Nellore
ANDHRA PRADESH 
08612312777

bakolaxmi@rediffmail.com 
Dr GM Bharat Kumar  Gram Clinical Research Karpagam Hospital  100 Vakkil New Street,Simmakkal, Madurai-625001
Madurai
TAMIL NADU 
0452-4243614
0452-4353614
gayathri@gramclin.com 
Dr Saji PO Thomas  Little Flower Hospital & Research Centre  Post Box 23,Angamaly-683572
Ernakulam
KERALA 
04843096666

spotsmsa4@hotmail.com 
Dr Meenakshi Sundaram  Vinayaka Mission Hospital  NH-47,Sankari Main Road, Veerapandi Post, Salem - 636 308,Tamil Nadu
Salem
TAMIL NADU 
04273982000

meenakshiortho@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Bezawada Central Ethics Committee for Dr.PavanKumar  Approved 
GRAM Ethics Committee for Dr GM Bharat Kumar  Approved 
Little Flower Hospital Independent Ethics Committee for Dr.Saji Thomas  Approved 
Simhapuri Independent Ethics Committee for Dr.Balakondaiah  Approved 
Vinayaka Mission Hospital Institutional Ethics Committee for Dr.Meenakshi Sundaram  Approved 
Visakha Central Ethics Committee for Dr.P Ashok Kumar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Osteoarthritis of the knee 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Glucosamine hydrochloride + Chondroitin sulfate   2 capsules to be taken every morning with breakfast and every evening before bedtime for 180 days  
Comparator Agent  Placebo  2 capsules to be taken every morning with breakfast and every evening before bedtime for 180 days  
Intervention  UC-II® (Undenatured Type II collagen)  2 capsules to be taken every morning with breakfast and every evening before bedtime for 180 days  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Ambulatory, male and female subjects 40 – 75 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2.
2.Female subjects of childbearing potential must agree to use a medically acceptable form of birth control throughout the duration of the study (e.g., oral or patch contraceptives, intrauterine device, Depo-Provera ®, or double-barrier) and have a negative pregnancy test at all study visits. Female subjects of non childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
3.Unilateral or bilateral OA of the knee for greater than 3 months (ACR criteria) and Kellgren and Lawrence radiographic grading of grade 2 or 3
4.VAS score during the most painful knee movement between 40-70 mm after 7 days withdrawal of excluded medications.
5.Lequesne’s functional index score between 6-10 points after 7 days withdrawal of excluded medications.
6.Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator.
7.Be willing and able to participate in all scheduled visits, dosing plan, tests and other trial procedures according to the clinical protocol.
8.Be willing to refrain from taking ibuprofen, aspirin or other NSAIDS (other than acetaminophen/paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial.
9.Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial.
 
 
ExclusionCriteria 
Details  1.History of hypersensitivity to NSAIDS, or any other similar pharmacological agents or components of the products.
2.History of hypersensitivity to eggs, chicken/fowl, or shellfish.
3.History of underlying inflammatory arthropathy or severe RA or OA (VAS score greater than 70).
4.Hyperuricemia (>440 µmol/L) and/or past history of gout.
5. Expectation of surgery in the next 4 months.
6.Recent injury in the area affected by OA of the knee (past 4 months).
7.Have taken any corticosteroid, indomethacin, glucosamine + chondroitin, within 3 months prior to the Treatment Period, Day 1 (Visit 2) or intra-articular treatment / injections with corticosteroid or hyaluronic acid or Omega-3 Fatty acids dietary supplements within 6 months preceding the treatment period. (A 2-week washout period is allowed for subjects taking omega-3 fatty acid supplements)
8.History of congestive heart failure.
9.Anticipated problems with product consumption.
10.Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies within the last 5 years
11.History of Systemic Lupus Erythematosus (SLE).
12.High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc).
13.Females who are pregnant or lactating or planning to become pregnant.
14.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
15.Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit (Visit 1).
 
 
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 
Mean change in WOMAC,LFI and VAS from baseline to end of the study.   Screening, Day 1, 7, 30, 60, 90, 120, 150 and 180 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in COMP and CRP value in serum.   Day 1, day 90 and day 180. 
Mean change in MMP-3 and IL-6 value in synovial fluid.
 
Day 1 and Day 180. 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   08/02/2013 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Brief Summary  

UC II®  (Undenatured (native) type-II collagen) is dietary supplement obtained from chicken sternum cartilage. Extensive preclinical and clinical studies in large population demonstrates the benefits of UC-II®  for increasing joint comfort, mobility and flexibility. UC-II®   is found to be both effective and safe for long-term usage without adverse events or gross perturbation to liver, kidney or heart biomarkers. Overall, supplementation with UC-II®   improves quality of life by alleviating joint pain thereby enhancing daily activities in osteoarthritic sufferers.

The proposed clinical trial is a Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Tolerability of UC-II® in modulating knee joint function. In this study a total of 66 subjects with age between 40-75 years will be recruited  and randomized in three different groups (UC-II, Glucosamine + Chondroitin and Placebo).The dosing period is for 6 months per subject with the follow up visits from the day 1, 7, 30, 60, 90, 120,150 and 180.The intensity of pain and quality of life will be assessment by using WOMAC, LFI and VAS. Also apart from normal laboratory parameters, the serum biomarkers like  COMP and CRP will be analyzing during day 1,day 90 and day 180 and Synovial fluid biomarkers like MMP-3 and IL-6  will be analyzing during day1 and day180.

 

 
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