| CTRI Number |
CTRI/2026/01/101273 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of BBETTER OrthoUrja for Knee and Joint Pain |
|
Scientific Title of Study
|
Efficacy and Safety of BBETTER OrthoUrja in Knee and Joint Pain Management: A Randomized, Double-Blind, Placebo-Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BBETTER/Ortho/Urja/25/01, Version 1.0; dt. 25th Feb 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeev Kumar Kare |
| Designation |
Site Manager |
| Affiliation |
Government Medical College & Govt. General Hospital |
| Address |
Department of Orthopaedics, OPD No:04 , Ground Floor, Government Medical College & Govt. General Hospital, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9912320517 |
| Fax |
08942-279000 |
| Email |
drsanjeevkumarkare@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Kumar Kare |
| Designation |
Site Manager |
| Affiliation |
Government Medical College & Govt. General Hospital |
| Address |
Department of Orthopaedics, OPD No:04 , Ground Floor, Government Medical College & Govt. General Hospital, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9912320517 |
| Fax |
08942-279000 |
| Email |
drsanjeevkumarkare@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Kumar Kare |
| Designation |
Site Manager |
| Affiliation |
Government Medical College & Govt. General Hospital |
| Address |
Department of Orthopaedics, OPD No:04 , Ground Floor, Government Medical College & Govt. General Hospital, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9912320517 |
| Fax |
08942-279000 |
| Email |
drsanjeevkumarkare@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MONKSAYS SUPERFOODS PVT. LYD. |
|
|
Primary Sponsor
|
| Name |
MONKSAYS SUPERFOODS PVT. LYD. |
| Address |
Plot no. 31, Sagar Society, Rd. no. 2, Banjara Hills,
Hyderabad, Telangana- 500034, India.
|
| Type of Sponsor |
Other [Private Limited Company (Nutraceutical / Wellness Products Company)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjeev Kumar Kare |
Government Medical College & Govt. General Hospital |
Department of Orthopaedics, OPD No:04 , Ground Floor, Government Medical College & Govt. General Hospital, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH |
9912320517
drsanjeevkumarkare@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Knee and Joint Pain Management |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BBETTER OrthoUrja Capsule 650 mg
|
One capsule after breakfast and dinner (twice daily) with ambient temperature water for 8 weeks. |
| Comparator Agent |
Placebo Capsule |
One capsule after breakfast and dinner (twice daily) with ambient temperature water for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants aged 30 to 70 years.
2. Mild to moderate knee/joint pain (VAS score 3 to 7).
3. Diagnosis of mild to moderate osteoarthritis (Kellgren-Lawrence Grade 1 to 3).
4. Pain duration of at least 3 months.
5. BMI between 18.5 and 30 kg/m².
6. Ambulatory and capable of performing basic physical activities.
7. Willingness to discontinue other joint health supplements or anti-inflammatory medications (except rescue acetaminophen).
8. No significant comorbidities or surgeries in the past 6 months.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in knee pain intensity using the Visual Analog Scale (VAS) from baseline. |
Baseline, Week 4, Week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores from baseline. |
Baseline, Week 4, Week 8 |
| Change in Timed Up and Go Test (TUG- Functional test assessing the time taken to rise from a chair, walk a short distance, and return) from baseline. |
Baseline, Week 4, Week 8 |
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) from baseline. |
Baseline, Week 4, Week 8 |
| Change in Numeric Pain Rating Scale (NPRS) score from baseline. |
Baseline, Week 4, Week 8 |
| Change in Short Form-12 (SF-12) for Quality of Life score from baseline. |
Baseline, Week 4, Week 8 |
| Change in Inflammatory Biomarkers (IL-6, TNF-a, CRP) from baseline. |
Baseline, Week 8 |
| Change in Cartilage and Joint Health Biomarkers (Cartilage Oligomeric Matrix Protein (COMP) and other factors) from baseline. |
Baseline, Week 8 |
| Change in Treatment-Emergent Adverse Events (TEAEs) from baseline. |
Baseline, Week 4, Week 8 |
| Change in Treatment-Emergent Serious Adverse Events (TESAE) from baseline. |
Baseline, Week 4, Week 8 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
22/01/2026 |
| 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="2"
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 study is designed to evaluate the efficacy and safety of BBETTER OrthoUrja in adults with mild to moderate knee and joint pain or osteoarthritis. The study will be conducted as a randomized double blind placebo controlled clinical trial. Eligible participants aged 30 to 70 years will be randomly assigned to receive either BBETTER OrthoUrja capsules or placebo capsules twice daily for a period of eight weeks.
The primary objective of the study is to assess the effect of BBETTER OrthoUrja on knee and joint pain as measured by the Visual Analog Scale. Secondary objectives include evaluation of physical function mobility quality of life and overall joint health using validated assessment tools such as WOMAC KOOS TUG NPRS and SF 12. Safety will be assessed through monitoring of adverse events vital signs and laboratory parameters including inflammatory and cartilage related biomarkers.
The hypothesis of this study is that BBETTER OrthoUrja will significantly reduce knee and joint pain improve functional outcomes and enhance quality of life compared to placebo while being safe and well tolerated. |