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CTRI Number  CTRI/2025/08/093579 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 01/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective non-interventional observational study 
Study Design  Single Arm Study 
Public Title of Study   A Study to Evaluate the Impact of Centrum Joint & Mobility Capsules (Vitamin and Mineral Supplement) in Participants with Knee Joint Pain  
Scientific Title of Study   A Multi-center, Single-arm, Observational Study to Evaluate the Impact of Centrum Joint & Mobility capsules on Knee Joint Comfort and Mobility in Participants with Primary uni/bilateral Knee Osteoarthritis (OA) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shrirang Limaye 
Designation  Coordinating Investigator 
Affiliation  Deoyani Multispeciality Hospital 
Address  Ground floor, Research Room, Orthopedic Department, Plot No, 121, Lane Number 4, Dahanukar Colony, Kothrud, Pune, Maharashtra 411038

Pune
MAHARASHTRA
411038
India 
Phone  9850811722  
Fax    
Email  drshriranglimaye@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Atul Sharma 
Designation  Senior Scientist 
Affiliation  Haleon India 
Address  Medical & Scientific Affairs Department, Haleon India, 10th Floor, DLF One Horizon Center Golf Course Road, DLF Phase 5, Gurgaon, India

Gurgaon
HARYANA
122002
India 
Phone  9820801694  
Fax    
Email  atul.x.sharma@haleon.com  
 
Details of Contact Person
Public Query  
Name  Dr Atul Sharma 
Designation  Senior Scientist 
Affiliation  Haleon India 
Address  Medical & Scientific Affairs Department, Haleon India, 10th Floor, DLF One Horizon Center Golf Course Road, DLF Phase 5, Gurgaon, India

Gurgaon
HARYANA
122002
India 
Phone  9820801694  
Fax    
Email  atul.x.sharma@haleon.com  
 
Source of Monetary or Material Support  
Haleon India, 10th Floor, DLF One Horizon Center Golf Course Road, DLF Phase 5, Gurgaon (Haryana), India, 122002 
 
Primary Sponsor  
Name  Haleon 
Address  10th Floor, DLF One Horizon Center Golf Course Road, DLF Phase 5, Gurgaon (Haryana), 122002, India 
Type of Sponsor  Other [Global Consumer Healthcare] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aashish Chaudhary  Akash Healthcare Super Speciality Hospital   Groud Floor, Room No 04, Department of Orthopaedics, Hospital plot, Road No 201, Sector-3, Dwarka, New Delhi-110075
New Delhi
DELHI 		 9818444333

director@aakashhealthcare.com 
Dr Sunil Shetty  D Y Patil Medical College & Hospital  5th Floor, Research Room, CRU Department, Dr. D Y Patil School of medicine building, Sector-5, Nerul, Navi Mumbai-400706, Maharashtra
Mumbai
MAHARASHTRA 		 9821288076

dr_sunilshetty@yahoo.co.in 
Dr Shrirang Limaye  Deoyani Multispeciality Hospital  Ground floor, Research Room, Orthopedic Department, Plot No, 121, Lane Number 4, Dahanukar Colony, Kothrud, Pune, Maharashtra 411038
Pune
MAHARASHTRA 		 9850811722

drshriranglimaye@gmail.com 
Dr Hrishikesh Patkar  Lifepoint Multispecialty Hospital  3rd Floor, Clinical research department room, Dept of Orthopedics, Sr. No. 145/1, Mumbai- Bangalore highway, Near Hotel Sayaji, Wakad, Pune-411057, Maharashtra
Pune
MAHARASHTRA 		 9011267776

patkarhrishikesh9@gmail.com 
Dr Aniket Gupta  Matis Multispeciality Hospital  1st Floor, Research Room, Department of Orthopedics, IPD Building, Opposite Adani CNG Gas Station, Near Motera BRTS Bus Stop, Cross Roads, Motera, Ahmadabad, Gujarat, 380005
Ahmadabad
GUJARAT 		 9825677971

guptaaniket30794@gmail.com 
Dr Vishal Patil   Medipoint Hospitals Pvt. Ltd  OPD building, Ground floor, Ortho research room, Orthopedic Department, Plot No. 38, Survey No. 49/2, Shivraj Chowk, Off Pune Nagar Road, Near Bhaji Market, Chandan Nagar, Pune - 411014
Pune
MAHARASHTRA 		 9405431728

dr.vishalpatil.pentagen@gmail.com 
Dr Manju Adithya Nayak Sreenivas  Medstar Speciality Hospital  2nd floor, Research Room, Department of Orthopedics, 641/17/1/3, Kodigehalli Main Road, Sahakar Nagar, Bangalore-560092, Karnataka,
Bangalore
KARNATAKA 		 9035302352

dradithyamedstar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Aakash Healthcare Institutional Ethics Committee  Approved 
Institutional Ethics Committee of Biomedical and Health records, D.Y Patil School of Medicine  Approved 
Lifepoint Research Ethics Committee  Approved 
Lifepoint Research Ethics Committee  Approved 
Medstar Speciality Hospital Ethics Committee  Approved 
Penta-Med Ethics Committee   Approved 
Shakti Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female participant over age of 35 years.
2. A participant prescribed with Centrum Joint & Mobility capsules, (1 capsule daily for at least 3 months).
3. Primary unilateral or bilateral knee mild to moderate OA diagnosed based on American College of Rheumatology criteria and the Kellgren-Lawrence grading system.
4. Symptoms of knee OA present for at least 1 month prior to screening.
5. Knee pain or discomfort visual analog scale (VAS) score more than or equal to 40 millimeter (mm) and less than or equal to 70 mm in the affected knee(s).
6. Participant taking a homemade remedy or over the counter (OTC) medicine, or on a regular dose of Nonsteroidal Anti-Inflammatory Drugs (NSAID) or paracetamol for up to 6 months, or even a participant not on any medication for OA will be included.
7. Willingness to adhere to study protocol and daily supplementation.
8. A signed informed consent.
 
 
ExclusionCriteria 
Details  1. Patient already on Centrum Joint and Mobility capsules.
2. History or presence of active rheumatic disease (example, rheumatoid arthritis), autoimmune disease like Psoriatic arthritis.
3. Serious systemic diseases (example, severe cardiac, renal, or hepatic conditions).
4. Secondary OA or other joint disorders (example, fibromyalgia, bursitis).
5. Use of joint supplements (example, glucosamine, chondroitin) within the last month.
6. Pregnant or lactating female.
7. Use of systemic or topical corticosteroids or other joint medications outside the study protocol in the last 6 months.
8. A participant who has been administered local steroids or other NSAIDs injections or other injectables (hyaluronic acid) to the affected knee(s) within the last 6 months.
9. A participant with a recent history of major knee injury or surgery.
10. A participant with a knee skin area pathological condition, such as open skin wounds, infections, inflammations, or exfoliative dermatitis conditions.
11. Participation in other studies (including nonmedicinal studies) involving investigational product(s) within 1 month before screening.
12. An employee of the site or Contract Research Organization (CRO), or sponsor, or a member of the study team.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change from Baseline in average Knee Injury and Osteoarthritis Outcome Score (KOOS) for Symptoms and Function-daily living at Week 12  Baseline and Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Change from Baseline in average KOOS score for Function-Sport and Recreational activities, and quality of life at Week 12  Baseline and Week 12 
Change from Baseline in average KOOS score for Symptoms, Function-daily living, Function-Sport and recreational activities, Quality of Life at Weeks 4 and 8  Baseline, Weeks 4 and 8 
Change from Baseline in knee pain or discomfort intensity using average VAS scoring at Weeks 4, 8, and 12  Baseline, Weeks 4, 8, and 12 
Change from Baseline in Leg strength as measured by average score from 30-second chair stand test at Weeks 4,8, and 12  Baseline, Weeks 4,8, and 12 
Change from Baseline in health-related quality of life average scores assessed by RAND-36, focusing on physical, emotional, and social well-being at Weeks 4, 8, and 12  Baseline, Weeks 4, 8, and 12 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   N/A 
Date of First Enrollment (India)   02/09/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 will be a prospective study designed to assess the effectiveness of Centrum Joint & Mobility capsules in improving knee joint pain or discomfort, mobility, and functional ability in participants over 35 years of age with primary uni or bilateral knee OA. The study will be conducted at approximately 7-9 sites across India. Participants will be recruited through the investigator’s Outpatient Department (OPD), referrals from healthcare providers, and outreach in clinical settings. Participants with OA who have been prescribed Centrum Joint & Mobility Capsules will be instructed to take one capsule, once daily for three months as advised in the prescription. During baseline assessment, data on participants’ baseline OA symptoms will be collected. To assess changes in knee joint health, mobility, and pain or discomfort over time, the investigator will follow-up with participant at site visits on Weeks 4, 8, and 12, which will include reassessments of knee pain or discomfort, functional ability, joint mobility, scales, and scores, quality of life, and safety. A total of 300 participants will be enrolled into the study to ensure approximately 200 complete the study.

 
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