| CTRI Number |
CTRI/2026/02/103909 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Osteocare bar on reducing inflammation in patients with knee osteoarthritis |
|
Scientific Title of Study
|
Evaluation of the anti-inflammatory effect of osteocare bar for knee osteoarthritis management: a double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srushti Sunil Deshpande |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul institute of Ayurved and Research |
| Address |
Department Of Kayachikitsa, Parul Institute of Ayurveda and Research,P.O.. Limda, Tal. Waghodia-391760 Dist. Vadodara, Gujrat(India)
Department Of Kayachikitsa, Parul Institute of Ayurveda and Research,P.O.. Limda, Tal. Waghodia-391760 Dist. Vadodara, Gujrat(India)
Vadodara
GUJARAT
391760
India |
| Phone |
8888638821 |
| Fax |
|
| Email |
srushtideshpande01091999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Kore |
| Designation |
Guide (Professor) |
| Affiliation |
Parul Institute Of Ayurved And Research |
| Address |
Department Of Kayachikitsa, Parul Institute of Ayurveda and Research,P.O.. Limda, Tal. Waghodia-391760 Dist. Vadodara, Gujrat(India)
Department Of Kayachikitsa, Parul Institute of Ayurveda and Research,P.O.. Limda, Tal. Waghodia-391760 Dist. Vadodara, Gujrat(India)
Vadodara
GUJARAT
391760
India |
| Phone |
8275174598 |
| Fax |
|
| Email |
drnareshkore46@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srushti Sunil Deshpande |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul Institute Of Ayurved And Research |
| Address |
Department Of Kayachikitsa, Parul Institute of Ayurveda and Research,P.O.. Limda, Tal. Waghodia-391760 Dist. Vadodara, Gujrat(India)
Department Of Kayachikitsa, Parul Institute of Ayurveda and Research,P.O.. Limda, Tal. Waghodia-391760 Dist. Vadodara, Gujrat(India)
Vadodara
GUJARAT
391760
India |
| Phone |
8888638821 |
| Fax |
|
| Email |
srushtideshpande01091999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved and research Department of kayachikitsa 3rd floor room no Parul
university,Ishwarpura, Limda,391760,Vadodara,Gujarat,India |
|
|
Primary Sponsor
|
| Name |
Srushti Sunil Deshpande |
| Address |
Parul Institute of Ayurved and research Department of kayachikitsa 3rd floor room no
Parul university,Ishwarpura, Limda,391760,Vadodara,Gujarat,India |
| Type of Sponsor |
Other [Self] |
|
|
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 Srushti Sunil Deshpande |
Khemdas Hospital |
OPD No. 10 Ground Floor Department of
Kayachikitsa Khemdas Hospital
Ishwarpura P.O Limda Waghodiya
391760 Vadodara Gujrat India
Vadodara
GUJARAT
Vadodara
GUJARAT |
08888638821
srushtideshpande01091999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE IEC-PIAR HR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. 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: Osteocare Bar, Reference: NA, Route: Oral, Dosage Form: , Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: , Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age Group: 35 to 70 years
2.Gender: Both male and female
3.Clinical Diagnosis:
ACR criteria for Osteoarthritis of knee joint will be used as diagnostic criteria.
4.Willingness to Participate:
Able to understand the study protocol
5.Willing to provide written informed consent and comply with study procedures |
|
| ExclusionCriteria |
| Details |
1.Secondary Osteoarthritis (e.g. post-traumatic, post-infectious, or metabolic bone disease)
2.Inflammatory Joint Disorders:
Rheumatoid arthritis
Gout
Psoriatic arthritis or any seronegative arthropathy
3.Systemic Illnesses:
Diabetes mellitus
Cardiac, hepatic, or renal impairment
4.Recent Joint Procedures:
Intra-articular steroid or hyaluronic acid injection within the past 3 months
5.History of knee surgery or arthroscopy within the last 6 months
6.Use of Joint-related Supplements or NSAIDs within 2 weeks before baseline screening
7.Known Allergy or Hypersensitivity to any of the ingredients in Osteocare Bar
8.Pregnant or Lactating Women
9.Participation in another Clinical Trial within the last 3 months
10.Psychiatric or Cognitive Disorders interfering with compliance |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in CRP Value |
day 0, 15, 30, 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved range of motion with Goniometer and pain reduction |
day 0, 15, 30, 60 |
|
|
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 2 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="1"
Months="6"
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
|
Knee osteoarthritis (Sandhigata Vata) leads to pain, stiffness, and limited joint movement, while conventional NSAID therapy has significant side effects. This study evaluates the anti-inflammatory efficacy of an Ayurvedic Osteocare Bar. A randomized double-blind placebo-controlled clinical trial will assess CRP levels, pain, and range of motion. The aim is to determine its safety and effectiveness in improving functional outcomes in mild to moderate knee osteoarthritis. |