| CTRI Number |
CTRI/2025/08/092291 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Evaluation of Herbal drug compound for the management of Janu Sandhi- Shoola (Knee joint Pain) w.s.r. to Osteo Artheritis. |
|
Scientific Title of Study
|
An Evaluation of Herbal drug compound for the management of Janu Sandhi- Shoola (Knee joint Pain) w.s.r. to Osteo Artheritis. |
| Trial Acronym |
Ayurvedic Drug |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kuldeep Kumar Pandey |
| Designation |
Professor and Head Dept of Sangyaharan |
| Affiliation |
IMS |
| Address |
Department of Sangyaharan, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09415251556 |
| Fax |
|
| Email |
pandeykk@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Kuldeep Kumar Pandey |
| Designation |
Professor and Head Dept of Sangyaharan |
| Affiliation |
IMS |
| Address |
Department of Sangyaharan, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09415251556 |
| Fax |
|
| Email |
pandeykk@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kuldeep Kumar Pandey |
| Designation |
Professor and Head Dept of Sangyaharan |
| Affiliation |
IMS |
| Address |
Department of Sangyaharan, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415251556 |
| Fax |
|
| Email |
pandeykk@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science |
| Address |
Banaras Hindu University Varanasi 221005 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Kuldeep Kumar Pandey |
IMS Banaras Hindu University |
Department of Sangyaharan, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
BHU
Varanasi
UTTAR PRADESH |
08957055789
pandeykk@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee |
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: SANDHIGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nigundi,parijat,Shigru,Shalaki,Babool and Tendu Nirayas, Reference: Dravyaguna Vigyan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
Knee joint pain, swelling with stiffness,
Redness, warmth to touch, Touching or crackling sound. |
|
| ExclusionCriteria |
| Details |
Trauma to Knee joint,Low backache with disc problem,DM,HTN,Thyroid problem. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain assessment scale Haemodynamics. |
- |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Biomarker Substance-p,TNF Alfa,Beta Endorphin. |
- |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
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
|
An Evaluation of Herbal drug compound for the management of Janu Sandhi- Shoola (Knee joint Pain) w.s.r. to Osteo Artheritis. |