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CTRI Number  CTRI/2025/10/096204 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 01/06/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Phase 3 Ayurvedic clinical study to assess the safety and benefits of using Boswellia Curcumin and Joint Aid Plus together in people having joint pain. 
Scientific Title of Study   A Phase III, Open-Label, Single-Arm, Single-Centered Clinical Study To Evaluate The Safety And Efficacy Of Combination Therapy Of Boswellia Curcumin And Joint Aid Plus In Subjects With Joint Pain. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CTSRS/2517 Version No 1.0 Dated 10 Jun 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr BN Satish 
Designation  Principal Investigator 
Affiliation  RVS Ayurvedic Medical College Hospital and Research Centre 
Address  Ground Floor, Room No.1, OPD Department, Srigandhadakavalu, Vishwaneedam Post, Outer Ring Road

Bangalore
KARNATAKA
560091
India 
Phone  789292914197  
Fax    
Email  drbnsatish@yahoo.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr. Vikram Chauhan  
Designation  Managing Director 
Affiliation  Planet Ayurveda Private Limited  
Address  Plot No. 627, JLPL, Industrial Area, Sector-82, Mohali, Punjab (India) PUNJAB 160055 India

Rupnagar
PUNJAB
160055
India 
Phone  8578888111  
Fax    
Email  trade@planetayurveda.com   
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr. Vikram Chauhan 
Designation  Managing Director  
Affiliation  Planet Ayurveda Private Limited  
Address  Plot No. 627, JLPL, Industrial Area, Sector-82, Mohali, Punjab (India) PUNJAB 160055 India

Rupnagar
PUNJAB
160055
India 
Phone  8578888111  
Fax    
Email  trade@planetayurveda.com   
 
Source of Monetary or Material Support  
Planet Ayurveda Private Limited, Plot No. 627, JLPL, Industrial Area, Sector-82, Mohali - 160055, Punjab (India). 
 
Primary Sponsor  
Name  Planet Ayurveda Private Limited 
Address  Plot No. 627, JLPL, Industrial Area, Sector-82, Mohali - 160055, Punjab (India) 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr BN Satish  RVS Ayurvedic Medical College, Hospital and Research Centre  Ground Floor, Room No.1, OPD Department, Srigandhadakavalu, Vishwaneedam Post, Outer Ring Road,
Bangalore
KARNATAKA 
7892914197

drbnsatish@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pranav Diabetes Center Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M255||Pain in joint. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Boswellia Curcumin & Joint Aid Plus, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -Each participant will receive both investigational products, taking a total of two capsules per day of each formulation, administered together for 90 consecutive days.
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age between 40 and 70 years (inclusive), of either sex.
2.Written informed consent obtained voluntarily prior to initiation of study-related procedures.
3.Clinical diagnosis of unilateral or bilateral knee osteoarthritis for more than 3 months, as determined by a physician based on clinical symptoms and physical examination.
4.Willingness and ability to comply with all scheduled visits, treatment regimen, study procedures, and completion of questionnaires (WOMAC, VAS, SF-36).
5.Stable general health condition with no major planned changes to existing medications during the study period. 
 
ExclusionCriteria 
Details  1.History of knee or hip joint replacement surgery, or significant hip or lower back pain that interferes with ambulation or could confound study assessments.
2.Anticipated requirement for orthopedic surgery during the 90 days treatment period.
3.Pregnant or lactating women, or women planning to conceive during the study period.
4.Participation in another clinical trial or use of any investigational drug within 30 days prior to screening.
5.Uncontrolled diabetes mellitus, defined as fasting blood glucose greater than 140 mg per dL or HbA1c greater than 7.5 percentage at last available assessment.
6.Chronic respiratory illnesses such as chronic obstructive pulmonary disease (COPD), or history of breathing disorders that may impact physical activity tolerance.
7.Current or recent (within 6 months) use of immunosuppressive medications, or diagnosis of an autoimmune disorder (e.g., rheumatoid arthritis, lupus).
8.Known allergy or hypersensitivity to Boswellia, curcumin, or any herbal ingredients in the investigational products.
9.Any other medical or psychiatric condition which, in the opinion of the investigator, may compromise Subject Safety or interfere with the objectives of the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in total WOMAC score from Baseline to Day 30 ± 3, Day 60 ± 3, and Day 90 ± 3 days. WOMAC assesses pain, stiffness, and physical function. Total score: 0–96 (higher = worse symptoms). Primary efficacy is the reduction in total WOMAC score from Baseline to Day 90 ± 3 days.
 
Day 0, Day 30 ±3 days, Day 60 ±3 days, Day 90 ±3 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in Visual Analogue Scale (VAS) Score for Joint Pain
2.Change in Quality of Life Score as measured by SF-36 from Baseline to Day 90
3.Incidence and Nature of Adverse Events (AEs)
4.Physical Examination and Vital Signs Monitoring 
Day 0, Day 30 ±3 days, Day 60 ±3 days, Day 90 ±3 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   28/10/2025 
Date of Study Completion (India) 10/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Brief Summary and Purpose of the Study

This Phase III, open-label, single-arm, single-centre clinical study demonstrated that the combination therapy of Boswellia Curcumin and Joint Aid Plus is a safe, well-tolerated, and effective intervention for the management of knee osteoarthritis–associated joint pain in adult participants over a 90-day treatment period. The study successfully met its primary efficacy objective, with the total WOMAC score showing a consistent and clinically meaningful reduction from Baseline to Day 90, indicating significant improvement in pain, stiffness, and physical function. The progressive decline in WOMAC scores across all visits reflects sustained symptomatic relief and enhanced joint mobility among participants. Secondary efficacy outcomes further supported the therapeutic benefit of the intervention. Participants demonstrated a notable reduction in joint pain intensity, as evidenced by the decrease in VAS scores over time. Additionally, a significant improvement in quality of life, as measured by the SF-36 questionnaire, was observed, indicating enhanced physical well-being, functional capacity, and overall health perception. High subject satisfaction scores further reinforce the positive clinical response and acceptability of the treatment. From a safety perspective, the combination therapy exhibited a favourable tolerability profile throughout the study duration. No serious adverse events (SAEs) were reported. All observed adverse events, including mild dizziness, headache, and nausea, were transient, non-serious in nature, and resolved without medical intervention. Furthermore, vital signs and physical examination findings remained stable, with no clinically significant changes observed, supporting the systemic safety of the intervention. High treatment compliance and the absence of major safety concerns further strengthen the reliability of the study outcomes. In summary, the findings of this study indicate that the combination of Boswellia Curcumin and Joint Aid Plus provides clinically meaningful improvements in osteoarthritis symptoms, pain reduction, and quality of life, while maintaining an excellent safety and tolerability profile. These results support its potential as an effective therapeutic option for the management of knee osteoarthritis. However, given the open-label and single-arm design, further randomized, controlled, and long-term studies are recommended to confirm these findings and to establish the comparative efficacy and durability of treatment outcomes.

 
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