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CTRI Number  CTRI/2023/04/052147 [Registered on: 28/04/2023] Trial Registered Prospectively
Last Modified On: 19/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   “To understand the safety and efficacy of Maxicuma® 100 Capsules and Maxicuma® 250 Capsules in patients suffering from knee pain.” 
Scientific Title of Study   A Randomized, Double Blind, Placebo Controlled, Three Treatment, Parallel Group Study to Evaluate the Safety and Efficacy of Maxicuma® 100 Capsules and Maxicuma® 250 Capsules in patients with Osteoarthritis of Knee 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
iVRS-CD-23-012, Version 01 Dated 27 Mar 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harish G 
Designation  Principal Investigator  
Affiliation  Madhu Ortho Clinic and Hospital 
Address  Madhu Ortho Clinic and Hospital 13, 4th Main, Hesarghatta Rd, 8th mile circle, T. Dasarahalli, Bengaluru, Karnataka 560057

Bangalore
KARNATAKA
560057
India 
Phone  9739019977  
Fax    
Email  drhari22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Channa Basavanna G Halasagi 
Designation  Medical Monitor 
Affiliation  Invitro Research Solutions Pvt. Ltd 
Address  Invitro Research Solutions Pvt. Ltd, Clinical Development Department, Medical Monitoring Divison, Room No 301, 3rd Floor No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal

Bangalore
KARNATAKA
560092
India 
Phone  6366947473  
Fax    
Email  channa@ivrs.org.in  
 
Details of Contact Person
Public Query  
Name  T Vijay Bhaskar 
Designation  Director- Clinical Development 
Affiliation  In Vitro Research Solutions Pvt. Ltd. 
Address  Invitro Research Solutions Pvt. Ltd, Clinical Development Department, Clinical Operations Divison, 2nd Floor No. 22 & 23,Kodigehalli Main Road, Sahakar Nagar Post, Hebbal

Bangalore
KARNATAKA
560092
India 
Phone  636675282  
Fax    
Email  vijay@ivrs.org.in  
 
Source of Monetary or Material Support  
India Glycols Ltd, Plot No-2-5, Pharma city Selaqui – 248011, Dehradun-Uttarakhand, India 
 
Primary Sponsor  
Name  India Glycols Ltd 
Address  Plot No-2-5, Pharma city Selaqui – 248011, Dehradun-Uttarakhand, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Girish H R  Akshaya Nursing Home  #33/34 Near to concord School, Balaji Avenue,2nd stage, Attur main road, Yelahanka new town, Bangalore – 560064 Department-Ortho floor-Ground floor, Room No 02(Consultation Room)
Bangalore
KARNATAKA 		 8028393392

girirudra@yahoo.co.in 
Dr Harish G  Madhu Ortho Clinic and Hospital  13, 4th Main, Hesarghatta Rd, 8th mile circle, T. Dasarahalli, Bengaluru, Karnataka 560057 Department - Ortho Floor- Ground Floor, Room - 01(Consultation Room)
Bangalore
KARNATAKA 		 9739019977

drhari22@gmail.com 
Dr Ashok Kumar P  Rajalakshmi Hospital and Research Centre  #21/1 Lakshmi Pura Main Road, Vidhyaranyapura Main Road,Department-ortho Floor-Ground floor- Room No 02(Consultation Room) Bangalore-560097 Karnataka, India
Bangalore
KARNATAKA 		 9986046906

ashok.p@gmail.com 
Dr Harshith N  Sunshine Healthcare  #2345, MIG, 16th B Main, 3rd Stage, B Sector, Yelahanka New Town,Department-ortho Floor-Ground floor- Room No 03(Consultation Room) Bengaluru, Karnataka 560064
Bangalore
KARNATAKA 		 9844141315

harshithortho@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
ACE Independent Ethics Committee  Approved 
ACE Independent Ethics Committee  Approved 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Maxicuma 100 capsule  2 capsules of Maxicuma equivalent to 100 to be orally administered with water once daily after the breakfast for the treatment duration of 90 Days 
Intervention  Maxicuma 250 capsule  2 capsules of Maxicuma equivalent to 250 to be orally administered with water once daily after the breakfast for the treatment duration of 90 Days 
Comparator Agent  Placebo Capsule  2 capsules of Placebo to be orally administered with water once daily after the breakfast for the treatment duration of 90 Days. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and female subjects 45-65 years (both inclusive) of age with a Body Mass Index (BMI)
of approximately 18 to 30 kg/m2.

2. Unilateral or bilateral OA of the knee for greater than 3 months (NICE criteria)
Note: According to the criteria from NICE, patients can be diagnosed with knee OA if they are 45 years or older, have movement-related joint pain and either no morning knee joint related stiffness or stiffness of 30 min or less.
3. Subjects with radiographic evidence by Kellgren - Lawrence grade 2 or 3
4. Female subjects of childbearing potential must be using a medically acceptable and reliable
form of birth control. (Hormonal pills and intra-uterine devices are not considered as a reliable method of contraception). Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
5. VAS score during the most painful knee movement between 40-70 mm
6. Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs.
7. Screening parameters are within normal range or considered not clinically significant by the
Principal Investigator
8. Drug naive subjects or subjects willing to refrain from using ibuprofen, aspirin or other
NSAIDS (other than acetaminophen/paracetamol as rescue) or any other pain reliever including topical application (OTC or prescription) and Omega 3 fatty acids during the entire
trial.
9. Willing to sign the informed consent and comply with study procedure. 
 
ExclusionCriteria 
Details  1. Female subjects, who are pregnant, breast feeding or planning to become pregnant.
2. Subjects with radiographic evidence by Kellgren - Lawrence grade 4.
3. Subject has known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including
aspirin).
4. Patients who are allergic or hypersensitive to turmeric or turmeric supplements.
5. History or presence of underlying inflammatory arthropathy, RA, severe OA, gout, Systemic Lupus Erythematosus (SLE), any disorders related to bleeding/clotting or any other systemic disorder affecting joints.
6. Subjects scheduled for surgery within 3 months of completing the study.
7. Recent injury in the area affected by OA of the knee (past 4 months)
8. History or presence of congestive heart failure.
9. Evidence or history of clinically significant (in the judgment of the Investigator)
hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,
neurologic diseases, or malignancies
10. High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as
cocaine, methamphetamine, marijuana, etc.)
11. History or presence of psychiatric disorder that may impair the ability of subjects to provide
written informed consent.
12. Participation in any other trials involving investigational or marketed products within 30
days prior to the Screening Visit
13. Have taken any corticosteroid, indomethacin, Glucosamine + chondroitin, within 3 months
prior to the Treatment Period, Day 0 (Visit 1) or intra-articular treatment / injections with
corticosteroid or hyaluronic acid or Omega-3 Fatty acids dietary supplements within 6 months preceding the treatment period. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Change in Pain Visual Analogue Scale (VAS) [100 mm].
2. Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) domain scores. 		 Timepoints: Baseline- Prior Randomization, End of Study- Day 90
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in Pain Visual Analogue Scale (VAS) [100 mm].
2. Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) domain scores.
3. Change in Physical performance (assessed by treadmill walk test).
4. Comparison of proportion of subjects using rescue medication.
5. Comparison of Patients and physicians global assessment of therapy.
6. Comparison of treatment emergent Adverse events (AEs). 		 1. Baseline to Day 30, Day 45 & Day 60.
2. Baseline to Day 30, Day 45, & Day 60.
3. Baseline to Day 30, Day 45, Day 60 & Day 90.
5. Baseline to End of Study- Day 90 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="180" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   08/05/2023 
Date of Study Completion (India) 10/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Osteoarthritis is a degenerative disease of the joint affecting aging populations worldwide. It has an underlying inflammatory cause, which contributes to the loss of chondrocytes, leading to diminished cartilage layer at the affected joints.The study is a Randomized, Double Blind, Placebo Controlled, Three Treatment, Parallel Group Study to Evaluate the Safety and Efficacy of Maxicuma® 100 Capsules and Maxicuma® 250 Capsules in patients with Osteoarthritis of Knee. The product curcumin possesses both anti-inflammatory and antioxidative activities. The anti-inflammatory effect of the curcumin is also realized through its potential to inhibit the production of inflammatory and catabolic mediators by chondrocytes4 . Maxicuma® Capsules are nutraceutical supplements with turmeric extracts rich in curcumin which is one of the potential anti-osteoarthritic agents under limelight. All the modulatory effects exerted by curcumin could be salvaged to provide an efficient therapeutic option in the management of osteoarthritis of knee. 
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