CTRI/2026/04/108650 [Registered on: 20/04/2026] Trial Registered Prospectively
Last Modified On:
31/08/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Nutraceutical
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A Study to Compare How Well Xtagen Solo™ Works and How Safe It Is for Treating Knee Osteoarthritis in People in India
Scientific Title of Study
A Prospective, Randomized, Open Label, Parallel GroupComparative Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Xtagen SoloTM in Subjects with Osteoarthritis of Knee Joints in Indian Population.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT-CE-XT-2025, Version 1.0 Dated 09-Feb-2026
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Veena RM
Designation
Head - Medical Affairs
Affiliation
CliniExperts Research Services Pvt. Ltd.
Address
RMZ Galleria, 1st floor, Ambedkar Colony, Yelahanka, Bengaluru, Karnataka, India Bangalore KARNATAKA 560064 India
Bangalore KARNATAKA 560064 India
Phone
9880902005
Fax
Email
veena.rm@cliniexpertsresearch.com
Details of Contact Person Scientific Query
Name
Dr Ashwini Kumar
Designation
CEO
Affiliation
CliniExperts Research Services Pvt Ltd
Address
Unit No. 324-325, City Centre Mall, Plot No. 5, Pocket 8, Block B, Sector 12 Dwarka
West DELHI 110075 India
Phone
9999219448
Fax
Email
ashwini.kumar@cliniexpertsresearch.com
Details of Contact Person Public Query
Name
Dr Ashwini Kumar
Designation
CEO
Affiliation
CliniExperts Research Services Pvt Ltd
Address
Unit No. 324-325, City Centre Mall, Plot No. 5, Pocket 8, Block B, Sector 12 Dwarka
West DELHI 110075 India
Phone
9999219448
Fax
Email
ashwini.kumar@cliniexpertsresearch.com
Source of Monetary or Material Support
Xania International DGMR LLC FZ Dubai UAE
Primary Sponsor
Name
Xania International DGMR LLC FZ
Address
Meydan Grandstand, 6th floor, Meydan Road, Nad Al Sheba, Dubai, U.A.E.
Pin Code- 00000
Room No-02, Ground Floor, Orthopedic OPD
C-8/9,Om Vihar Phase 1 RD. opp. Metro Pillar No-709,Uttam Nagar West, Phase 1A, Om Vihar, Uttam Nagar, Delhi, New Delhi, Delhi 110059 West DELHI
9212488886
drpramod7@gmail.com
Dr Sharath Kumar M
Navya Multispeciality Hospital
Room No-04, Ground Floor, Orthopedic Unit,
366/319, Beside RR GOLD Palace, Bangalore Bellary Road, Old town Yelhanka, Bangalore 560064 Bangalore KARNATAKA
9731445638
sharathortho333@gmail.com
Dr P K Raju
Sushruta Orthopaedic, and Eye Care Center and Skin Care Center
Orthopedic Unit, Ground Floor, Division Orthopedic Surgery
Sushruta Orthopaedic, and Eye Care Center and Skin Care Center, 1/1,1st Temple Road, 15th Cross, Malleshwaram, Bangalore 560003 Bangalore KARNATAKA
Good Society for Ethical Research Independent Ethical Committee
Approved
Good Society for Ethical Research Independent Ethical Committee
Approved
Infinity Care Hospital Ethics Committee
Approved
Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: M17||Osteoarthritis of knee,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
SOC
Oral NSAIDs for the first 10 days and Physical
Therapy for 45 days
Intervention
Xtagen SoloTM + SOC
Xtagen SoloTM administered for 45 days + SOC (Oral NSAIDs for the first 10 days and Physical Therapy for the 45 days)
Inclusion Criteria
Age From
30.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Men and women aged more than or equal to 30 to less than or equal to 75 years (both inclusive).
2. Diagnosis: Diagnosis of osteoarthritis of the knee joint established in accordance with the classification criteria of the American College of Rheumatology (ACR) and with X-ray signs of grade II or III according to the Kellgren-Lawrence classification.
3. Disease Activity: The WOMAC pain subscale score greater than or equal to 2 in the index knee or a VAS pain score between 40 mm and 90 mm in the index knee (with less than or equal to 30 mm in the contralateral knee).
4. Regular use of oral NSAIDs for knee pain on greater than or equal to 15 days per month in the 3 months prior to screening.
5. Consent: Able and willing to provide written informed consent.
6. Compliance: Willing to comply with study visits, treatment, and procedure.
7. Women patients willing to use effective methods of contraception throughout the study duration.
ExclusionCriteria
Details
1. Subjects will be excluded if CRP is more than 10 mg/L and/or ESR more than 30 mm/hr at screening, unless the principal investigator determines that these elevated values are due to a temporary, non-inflammatory condition and not related to an underlying rheumatologic disorder.
2. Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2.
3. Concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis etc.).
4. Significant (requiring surgical treatment) valgus or varus deformity of the knee joint, ligamentous laxity, or destruction of the meniscus.
5. Concomitant osteoarthritis of the hip and/or ankle joints, of severe grade, which may make it difficult to assess the pain in the target knee joint.
6. History of septic arthritis of any joint or suspected subacute infectious inflammation in the target knee joint.
7. History of surgery of the targeted knee joint.
8. Planned surgery on any joint of the lower extremities during the study.
9. Lymphovenous insufficiency of the lower limbs, grade III.
10. Diseases and concomitant conditions affecting the structure and density of bone tissue (osteodystrophy due to hyperparathyroidism, malabsorption syndrome, osteomalacia, osteogenesis imperfecta, etc.).
11. History or current severe cardiovascular diseases, including: NYHA Class III or IV chronic heart failure, clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction, heart and coronary vessel surgery, significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure more than 180 mm Hg and diastolic blood pressure more than 110 mm Hg, pulmonary embolism or deep vein thrombosis.
12. History of Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus (HbA1c more than 8.5 percent and/or fasting plasma glucose more than 180 mg/dl at screening or episodes of severe hypoglycaemia 1 month); HbA1c report within 60 days is acceptable.
13. Subjects with BMI more than or equal to 40 kg/m2.
14. Severe diseases of the central nervous system, including seizures in history or conditions that may lead to their development; stroke or transient ischemic attack within 12 months prior to screening; head injuries or loss of consciousness within 12 months prior to screening; a brain tumor.
15. Diseases manifested by increased bleeding (hemorrhagic diathesis, haemophilia, thrombocytopenia, etc.), or conditions with a high risk of bleeding.
16. Significant uncontrolled concomitant disease, such as neurological, renal, hepatic, endocrine and gastrointestinal which according to the Investigator, could prevent the patient from participating in the study.
17. Participation in other clinical studies or administration of investigational products within 4 weeks prior to screening.
18. HIV, active viral (hepatitis B and C) or a cirrhotic liver disease in medical history.
19. Malignancies within the last 5 years (except for basal cell carcinoma of the skin and cervical cancer in situ that had undergone surgical removal or treatment).
20. History or current use of Drug of abuse, excessive alcohol intake, which in the opinion of the Investigator, makes the patient unsuitable for participation in the study.
21. Pregnant or lactating women or women planning a pregnancy during the clinical study.
22. Hypersensitivity to any of the components of the investigational product in medical history.
23. Prior therapy with the following drugs: • Intra-articular administration of any medicinal products within 4 weeks prior to screening. • Administration of oral slow-acting products, including dietary supplements for the treatment of osteoarthritis of the knee joint (chondroitin sulfate, glucosamine sulphate, piascledine, diacerein) within 3 months prior to screening.
• Administration of bisphosphonates, strontium ranelate, hormone replacement therapy, parathyroid hormone preparations, preparations of monoclonal antibodies to RANKL, active metabolites of vitamin D within 12 months prior to screening.
• Administration of other products that can affect the metabolism of bone tissue (antiepileptic preparations, anabolic steroids, etc.) 4 weeks (28 days) prior to screening.
24. Inability to read or write, unwillingness to understand and follow procedures of study protocol, as well as any other concomitant medical or serious mental conditions that make the patient unfit to participate in the study, limit the legality of obtaining informed consent or can affect patient’s ability to participate in the study
25. Allergy/Intolerance: Known hypersensitivity to Xtagen SoloTM or any investigational products ingredients.
26. Other conditions: Any psychiatric, neurological, or systemic condition that in the investigator’s opinion may interfere with study participation or data interpretation.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change in WOMAC scores between treatment groups (Xtagen SoloTM for 45 days + 10 days SOC vs 10 days SOC alone) from baseline to Week 6 (Day 45±2) in patients with osteoarthritis of knee joints in Indian population.
Day 1 Week 0, Day 21 Week 3 and Day 45 Week 6
Secondary Outcome
Outcome
TimePoints
1.Change in WOMAC scores with Xtagen SoloTM therapy administered for 45 days in conjunction with a 10 days regimen from baseline to Week 3 Day 21
2. Proportion of patients classified as responders according to the OMERACT OARSI responder criteria at Week 3 Day 21 & Week 6 Day 45
3. Change in the Patient Global Pain Assessment (VAS) score from baseline to Week 3 Day 21 & Week 6 Day 45
4. The Change in EQ 5D scores from baseline to Week 3 & Week 6 Day 45
Day 1 Week 0, Day 21 Week 3 & Day 45 Week 6
Target Sample Size
Total Sample Size="150" Sample Size from India="150" Final Enrollment numbers achieved (Total)= "150" Final Enrollment numbers achieved (India)="150"
This is a randomized, open-label, parallel-group, active-controlled, multicentric clinical study in India to evaluate the efficacy and safety of Xtagen Solo administered for 45 days as an add-on to standard of care in adult patients with mild to moderate osteoarthritis of the knee. Standard of care includes oral NSAIDs for 10 days and physical therapy for 45 days. Eligible patients aged 30 to 75 years with osteoarthritis of the knee diagnosed as per American College of Rheumatology criteria and Kellgren-Lawrence Grade II or III will be randomized in a 1:1 ratio to receive either Xtagen Solo plus standard of care or standard of care alone for 45 days. The total study duration per subject will be 6 weeks. Study visits include screening, baseline and randomization, Week 3 assessment, and Week 6 end-of-study assessment. Efficacy will be assessed primarily using WOMAC scores. Safety will be evaluated through adverse event monitoring, vital signs, laboratory investigations, and assessment of gastrointestinal tolerability.