| CTRI Number |
CTRI/2023/05/053146 [Registered on: 26/05/2023] Trial Registered Prospectively |
| Last Modified On: |
10/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare the effect of Agnikarma done by different types of metal Shalaka in Janusandhigatavata |
|
Scientific Title of Study
|
A randomized comparative trial to assess the effect of Agnikarma done by different Lauha Shalaka in Janusandhigatavata (knee osteoarthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrFarista |
| Designation |
PG Scholar |
| Affiliation |
National institute of Ayurveda Jaipur |
| Address |
Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan – 302002
Jaipur
RAJASTHAN 302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
8949379148 |
| Fax |
|
| Email |
Farishtagodara7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Sharma |
| Designation |
Associate Professor |
| Affiliation |
National institute of Ayurveda Jaipur |
| Address |
Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan – 302002
Jaipur
RAJASTHAN 302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9418159666 |
| Fax |
|
| Email |
Sumanhp2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Sharma |
| Designation |
Associate Professor |
| Affiliation |
National institute of Ayurveda Jaipur |
| Address |
Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan – 302002
Jaipur
RAJASTHAN 302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9418159666 |
| Fax |
|
| Email |
Sumanhp2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
Dr Farista |
| Address |
National Institute of Ayurveda Deemed To Be University (De-Novo) Jorawar Singh Gate Amer Road Jaipur Rajasthan – 302002 |
| 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 Farista |
National institute of Ayurveda,Jaipur |
OPD NUMBER - 32 National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan – 302002 Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
8949379148
farishtagodara7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Sutra Sthan 12, Procedure details: Agnikarma with Rajata Shalaka once a week for 3 weeks))
(1) Medicine Name: Placebo, Reference: None, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Duration: 3 Weeks | | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Sutra Sthan 12, Procedure details: Agnikarma with Suwarna Shalaka once a week for 3 weeks)
(1) Medicine Name: Placebo, Reference: none, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Duration: 3 Weeks | | 3 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Sutra Sthan 12, Procedure details: Agnikarma with Panchlauha Shalaka once a week for 3 weeks)
(1) Medicine Name: Placebo, Reference: None, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Duration: 3 Weeks | | 4 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Sutra Sthan 12, Procedure details: Agnikarma with Tamra Shalaka once a week for 3 weeks)
(1) Medicine Name: Placebo, Reference: None, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Duration: 3 Weeks | | 5 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Sutra Sthan 12, Procedure details: Agnikarma with Lauha Shalaka once a week for 3 weeks)
(1) Medicine Name: Placebo, Reference: None, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Duration: 3 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-Patients of either sex with the age group between 50yrs. to 70 yrs.
• Clinical features of Sandhigatavata for more than 6 months with the X-ray findings of Grade 1st, 2nd and 3rd on the basis of Kellgren-Lawrence score. |
|
| ExclusionCriteria |
| Details |
-Above 70 years of age
• Below 50 years age of patients.
• Rheumatoid arthritis, Gouty arthritis.
• Patients with local infection or skin diseases, on the proposed site of Agnikarma.
• Patient suffering from diabetes mellitus, cardiovascular diseases, HIV, hepatitis, endocrinal disorders, hypertension, infective arthritis, malignancy.
• Pregnant and lactating mother.
• Within 6 months of surgery or injury.
• Contraindications for Agnikarma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of effective Lauha Shalaka for Agnikarma in Janu Sandhigatavata. on the basis of Change in WOMAC scale.
|
At baseline, 1st week, 2nd week, 3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To validate the effect of Agnikarma in the management of Janu Sandhigatavata. |
At 5th week |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/06/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Participants attending the OPD and IPD of the NIA hospital and satisfying the selection criteria will be selected. All the participants who voluntarily agree to participate and provide informed written consent for participation will be recruited in the study. Total 75 participants will be selected after detailed examination and divided in 5 group of 15 patients each as per study protocol. All Procedures will be executed done under aseptic condition . Patient will be taken for follow-up initially 7 th day ,14th day , 21 st day ,follow up for next 4 weeks ( 2 weekly interval ). |