| CTRI Number |
CTRI/2025/10/096034 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the Effect of Ostikot Forte Tablet in Knee Joint Pain due to Osteoarthritis |
|
Scientific Title of Study
|
Effectiveness of Ostikot Forte Tablet in Osteoarthritis of Knee joint -A Quasi- Experimental Study |
| 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 Anoop AK |
| Designation |
Medical officer |
| Affiliation |
Vaidyaratnam P S Variers Aryavaidyasala Kottakkal |
| Address |
Vaidyaratnam P S Variers Aryavaidyasala Kottakkal
Malappuram
KERALA
676503
India |
| Phone |
04832806520 |
| Fax |
|
| Email |
researchmarketing@aryavaidyasala.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anoop AK |
| Designation |
Medical officer |
| Affiliation |
Vaidyaratnam P S Variers Aryavaidyasala Kottakkal |
| Address |
Vaidyaratnam P S Variers Aryavaidyasala Kottakkal
Malappuram
KERALA
676503
India |
| Phone |
04832806520 |
| Fax |
|
| Email |
researchmarketing@aryavaidyasala.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anoop AK |
| Designation |
Medical officer |
| Affiliation |
Vaidyaratnam P S Variers Aryavaidyasala Kottakkal |
| Address |
Vaidyaratnam P S Variers Aryavaidyasala Kottakkal
Malappuram
KERALA
676503
India |
| Phone |
04832806520 |
| Fax |
|
| Email |
researchmarketing@aryavaidyasala.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam P.S Varier Aryavaidyasala Kottakkal P.O Malappuram Kerala 676503 |
|
|
Primary Sponsor
|
| Name |
The managing trustee |
| Address |
Department of Clinical Research and marketing Vaidyaratnam P S Variers Aryavaidysala Kottakkal Malappuram
KERALA
676503
India |
| Type of Sponsor |
Other [Charitable institution] |
|
|
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 Anoop AK |
Arya Vaidya Sala Hospital, Kottakkal |
Special OPD
Malappuram
KERALA |
04832806520
researchmarketing@aryavaidyasala.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Aryavaidyasala |
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: Ostikot Forte, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
51.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Participants with knee joint pain satisfying the diagnostic criteria |
|
| ExclusionCriteria |
| Details |
1.History of rheumatoid arthritis or other inflammatory joint diseases
2.Known case of Malignancy
3. Known Cardiovascular disorders (such as Coronary artery disease, Rheumatic heart disease, congenital heart disease and Cardiac myopathy)
4. Known Hepatic disorders and Endocrinal disorders
5. Pregnant and lactating females
6. Any other condition that may jeopardize the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Reduction: Measured using the Visual Analog Scale (VAS) for pain at baseline & after 2 weeks, 1 month and 3months |
90days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Joint Function & Mobility: Assessed using the WOMAC Index 9(Western Ontario & McMaster Universities Osteoarthritis Index)- at baseline & after 2 weeks, 1 month & after 3 months
Blood test – Calcium blood test, blood vitamin D TEST - at baseline & after 1 month
BMD test - at baseline & after 3 months
|
14days |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
11/12/2025 |
| 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="8"
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 quasi-experimental study evaluates the effectiveness of Ostikot Forte Tablet in knee osteoarthritis. Thirty-two patients (aged 51–80 years) will receive 2 tablets twice daily for 90 days. Outcomes include pain reduction (VAS), joint function (WOMAC), and bone health (calcium, vitamin D, BMD). The study aims to provide evidence on its role in improving pain, mobility, and bone strength. |