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CTRI Number  CTRI/2024/06/068625 [Registered on: 10/06/2024] Trial Registered Prospectively
Last Modified On: 07/06/2024
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 Clinical Study to assess efficacy and safety of Green-Lipped Mussel Oil on joint health in older adults. 
Scientific Title of Study   A Prospective, Randomized, Double-Blind, Parallel Group, Three Arm, Study to Evaluate the Effectiveness and Safety of Green-Lipped Mussel Oil (GLMO) on Joint Health in Older Adults. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
LCBS-GHW-115 Version 1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raju KP 
Designation  Professor and HOD 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of Orthopedics, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  8792516793  
Fax    
Email  drrajukp.bgsgims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jestin VThomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd 
Address  No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jestin VThomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd 
Address  No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
Great HealthWorks, Inc. 4150 SW 28th Way Fort Lauderdale, FL 33312 United States of America 
 
Primary Sponsor  
Name  Great HealthWorks, Inc. 
Address  4150 SW 28th Way Fort Lauderdale, FL 33312 United States of America 
Type of Sponsor  Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raju KP  BGS Global Institute of Medical Sciences  Room No.02, Ground Floor, Department of Orthopaeidcs No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA 		 8792516793

drrajukp.bgsgims@gmail.com 
Dr Pulkit Prafulchandra Maniar  Parikh Multispecialty Health Care Pvt Ltd  Room No.05, Department of Orthapedics,A 4, Bhagvati Park Soceity, Opposite Tube Company Near Apollo Clinic ,Old Padra Road
Vadodara
GUJARAT 		 9913970010

drpulkitpm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, BGS Global Institute of Medical Sciences  Approved 
Parikh Institutional Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M15-M19||Osteoarthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GLMO-A  Oral Administration of 4 GLMO-A capsules once a day for 8 weeks  
Intervention  GLMO-B  Oral Administration of 2 GLMO-B capsules once a day for 4 weeks 
Comparator Agent  Placebo  Oral Administration of 2 Soybean Oil capsules once a day for 4 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Subject with Osteoarthritis (OA) (Class I-III), according to Kellgren and Lawrence system and confirmed by X-ray, who have been completely withdrawn from their previous analgesics or anti-inflammatory medications or have been newly diagnosed with mild to moderate OA, and who are not currently taking any analgesics or anti-inflammatory medications
2.Subjects with a body mass index (BMI) ≤ 29.9 kg/m2
3.Subjects willing to and able to perform the treadmill walking test
4.Subject willing to and able to complete the questionnaires required for the study
5.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
6.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study. 
 
ExclusionCriteria 
Details  1. Subjects with any history of fracture involving the study joint or with any other type of arthritis or OA secondary to a known disorder such as rheumatoid arthritis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, and psoriasis.
2. Subjects who had surgery, or arthroscopy within three months prior to inclusion
3. Subjects with severe bone or joint deformation or condition
4. Subjects who have been administered hyaluronic acid injections within six months prior to screening and
glucosamine and/or chondroitin containing compounds within seven days prior to the screening visit
5. Subjects who have used medications with MMP-inhibitory properties or took corticosteroids within 28 days of Screening Visit.
6. Subjects with history of Any chronic health condition,Psychiatric illness, Drug abuse, smoking, abuse or addiction to alcohol, Bariatric surgery or eating disorder such as bulimia or binge eating, Cardiovascular surgery, History of any other major surgery
7. Subjects on any medical treatment either systemic or topical which may interfere with the performance of
the study treatment
8. Subjects who have experienced a known stressful event within the last 6 months such as death in family,
accident, hospitalization
9. Subjects with a known allergy to herbal products
10. Subjects who are pregnant or lactating or nursing
11. Known HIV or Hepatitis B positive or any other immuno-compromised state
12. Currently participating or having participated in another clinical trial during the last 3 months prior to the
beginning of this study

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean Change in questionnaire based assessments, scale and performance evaluation  Day 0, Day 2, Day 28, Day 30,Day 56, Day 58, Day 84, Day 86 
 
Secondary Outcome  
Outcome  TimePoints 
Change in biomarker levels  Day 0, Day 28, Day 56, Day 84 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   18/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a double blind, randomized (1:1:1), controlled, parallel group, three arm study. Adult individuals meeting all inclusion and no exclusion criteria, after signing a written informed consent will be enrolled in the study. During recruitment, assessments will be performed for patient selection as a means of standardizing the extent of pain and immobility. After confirmation of the eligibility criteria, subjects will be randomized into one of the three treatment arms. The treatment duration will be 84 days. The efficiency of supplementation on the subject’s OA symptoms will be evaluated. Efficacy assessments will be done during all the site visits. The subjects will be contacted to obtain the details of analgesic use and complete the symptom assessment questionnaires. 
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