| CTRI Number |
CTRI/2025/10/096204 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M255||Pain in joint. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/10/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Brief Summary and Purpose of the Study This clinical study is designed to evaluate the safety and effectiveness of a combination of Boswellia Curcumin and Joint Aid Plus in people suffering from joint pain due to knee osteoarthritis. Osteoarthritis is a common age-related condition that causes pain, stiffness, and difficulty in joint movement. Both Boswellia serrata (Shallaki) and Curcuma longa (Turmeric) are known in Ayurveda for their natural anti-inflammatory and pain-relieving properties. Joint Aid Plus is a polyherbal Ayurvedic formulation containing herbs like Shallaki, Nirgundi, and Ashwagandha, which help reduce joint pain and improve flexibility. The purpose of this study is to see how well the combination therapy works in improving pain, joint function, and overall quality of life over a period of 90 days using standard tools like WOMAC, VAS, and SF-36 questionnaires. This is a Phase III, open-label, single-arm, single-center study involving 60 participants who will receive the investigational products for 90 days. The study will also assess the safety and tolerability of the herbal formulations through regular health checks and monitoring of any side effects. |