| CTRI Number |
CTRI/2026/01/100021 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Ajaasthibhasma and Panchtiktaghrita in the Management of JanusandhigataVata (Knee joint pain) by assesing the improvement in WOMAC Score. |
|
Scientific Title of Study
|
Clinical Efficacy of Ajaasthibhasma and Panchtiktaghrita in the Management of JanusandhigataVata (Osteoarthritis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajendra Kumar Soni |
| Designation |
Associate Professor Department of Kayachikitsa |
| Affiliation |
Choudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room Number 147 1st floor Instiute Block Department of Kayachikitsa Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi
South West
DELHI
110073
India |
| Phone |
8506964826 |
| Fax |
|
| Email |
dr.rajendrasoni@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Vd Rakesh sharma |
| Designation |
Professor |
| Affiliation |
Guru Ravidas Ayurveda University |
| Address |
Room Number 01 Second Floor PhD Section Board Of Ayurvedic and Unani System of Medicine Punjab Medical Education Bhawan Sector 69 Mohali Punjab
Rupnagar
PUNJAB
160062
India |
| Phone |
9814779242 |
| Fax |
|
| Email |
vaidyaras03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Vd Rakesh sharma |
| Designation |
Professor |
| Affiliation |
Guru Ravidas Ayurveda University |
| Address |
Room Number 01 Second Floor PhD Section Board Of Ayurvedic and Unani System of Medicine Punjab Medical Education Bhawan Sector 69 Mohali Punjab
Rupnagar
PUNJAB
160062
India |
| Phone |
9814779242 |
| Fax |
|
| Email |
vaidyaras03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Kumar Soni |
| Address |
Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi |
| 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 Rajendra Kumar Soni |
Kayachikitsa OPD Ground Floor Choudhary Brahm Prakash Ayurved Charak Sansthan |
Room Number 147 Department of Kayachikitsa Choudhary Brahm Prakash Ayurved Charak Sansthan
South West
DELHI |
8506964826
dr.rajendrasoni@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee GRAUP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M17||Osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ajaasthi bhasma, Reference: siddhi nandan mishra page 566 567, Route: Oral, Dosage Form: Bhasma, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm milk), Additional Information: -(2) Medicine Name: panchtikta ghrita, Reference: bhaisajya ratnavali visphot adhyay 58/20, Route: Oral, Dosage Form: Ghrita, Dose: 6(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Ambulatory patients
Patients with Primary Osteoarthritis (knee) fulfilling the diagnostic criteria of osteoarthritis recommended by the American College of Rheumatology. ACR clinical classification criteria
|
|
| ExclusionCriteria |
| Details |
Age below 40 years and above 70 years.
Patients suffering from osteoarthritis for more than 5 years’ duration.
Patients with ligamental injury or in other surrounding tissues of knee joint.
Patients having severe Osteoarthritic changes. hypertension 160/100 diabetes mellitus 7%
Patients with bony deformity.
Pregnant women and complicated cases of OA.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain, joint stiffness and improvement in joint function and mobility, assessed through standardized functional tests (e.g., Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC score]. |
Patients will be assessed at every 2 weeks for 75 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in the following clinical features:-
1] Sandhishool [Pain in joints]
2] Sparshasahyata [Tenderness in joints]
3] Sandhishotha [Swelling in joints]
4] Sandhigraha [Stiffness in joints] |
Patients will be assessed at every 2 weeks for 75 days. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
02/02/2026 |
| 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="0"
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 single arm, open label, no parallel group, trial to evaluate the Clinical Efficacy of Ajaasthibhasma and Panchtiktaghrita in the Management of JanusandhigataVata (Osteoarthritis). It will have one group of 40 patients with drugs ajaashthi Bhasma 500mg and Panchtikta Ghrita 6ml two times in a day. Duration will be 60 Days. Primary outcome being reduction in pain, joint stiffness and improvement in joint function and mobility, assessed through standardized functional tests- Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC score] as a standardized scientific tool to evaluate the efficacy of ayurvedic treatments for Knee Osteoarhritis by CCRAS |