| CTRI Number |
CTRI/2025/05/086886 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate efficacy of an ayurvedic formulation in the treatment of joint disease. |
|
Scientific Title of Study
|
Experimental and Clinical evaluation of Antiarthritic activity of an Ayurvedic formulation for the treatment of Sandhigata vata w.s.r.to 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 |
Dr Suresh Kumar Jaiswara |
| Designation |
Reader, Department of Dravyaguna Vijnana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital
294/3/1 A.P.C Road, Kolkata
Department of Dravyaguna Vijnana ,
room no t11
Kolkata
WEST BENGAL
700009
India |
| Phone |
9681098261 |
| Fax |
|
| Email |
dr.sureshkjaiswara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Kumar Jaiswara |
| Designation |
Reader, Department of Dravyaguna Vijnana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital
294/3/1 A.P.C Road, Kolkata, Department of Dravyaguna Vijnana,Room no t11
Kolkata
WEST BENGAL
700009
India |
| Phone |
9681098261 |
| Fax |
|
| Email |
dr.sureshkjaiswara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayanti Biswas |
| Designation |
M.D. Scholar Dept. of Dravyaguna Vijnana IPGAE&R at S.V.S.P |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Dravyaguna Vijnana Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital
294/3/1 A.P.C Road, Kolkata, Depatment of Dravyaguna Vijnana, Room no t11
Kolkata
WEST BENGAL
700009
India |
| Phone |
9153694870 |
| Fax |
|
| Email |
jayanti.jbroy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital , 294/3/1 ,A.P.C. Road, Kolkata, West Bengal-700009 , India |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospita, Govt. of West Bengal |
| Address |
294/3/1 A.P.C Road, Kolkata-700009 |
| 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 |
| Dr Jayanti Biswas |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
294/3/1 A.P.C Road, Kolkata-700009,Depatment of Dravyaguna Vijnana , Room no t11
Kolkata
WEST BENGAL |
9153694870
jayanti.jbroy@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Clinical Trial on Human Subject, IPGAER, Kolkata |
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: Gokshura and Sunthi, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 56 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having age between 40-70 years.
2,Patients of both sexes, irrespective of religion, habitat, income status, occupation etc.
3.Patients having symptoms of pain and swelling in the knee joints.
4.Kellgren Lawrence (Radiological scale) of e 2.
5.Patients with primary osteoarthritis-knee joints (single or both knees).
6.Patient willing to include themselves in the study through informed consent form. |
|
| ExclusionCriteria |
| Details |
1.Patients having age bellow 40 and above 70 years.
2.patients suffering with disease like cardiac problem, diabetes mellitus, hepatic disorder, renal disease, malignancies, pregnant mother etc.
3.patients who are currently participating in any other clinical trails. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be measured based on clinical outcome measures, Radiological outcome measures, Bio-chemical outcome measures, safety and tolerability outcome measures to determine the effectiveness and safety of the test drug for the treatment of Sandhigatavata (Osteoarthritis). |
56 days (8 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In the secondary outcome the effects of the test drug changing in the quality life to be assessed after completion of the treatment. |
56 days (8 weeks) |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
09/06/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.sureshkjaiswara@gmail.com].
- For how long will this data be available start date provided 06-01-2026 and end date provided 06-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This clinical study which will take place at OPD and IPD of the IPGAE&R at SVSP Hospital, a single arm open label interventional clinical study of a Ayurvedic formulation for the treatment of Sandhigatavata (Osteoarthritis) on 60 patients for 56 days. The primary outcome will be measured based on clinical outcome measures, radiological outcome measures, bio-chemical outcome measures, safety and tolerability measures to determine the effectiveness and safety of the test drug for the treatment of Sandhigatavata (Osteoarthritis). The secondary outcome is the effects of the test drug in changing of quality of life to be assessed after completion of the treatment. |