| CTRI Number |
CTRI/2023/05/052418 [Registered on: 09/05/2023] Trial Registered Prospectively |
| Last Modified On: |
07/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Comparative Trial On Agnikarma And Jalaukavacharana in Sandhigata Vata With special Reference To Knee Osteoarthritis |
|
Scientific Title of Study
|
A Randomised Comparative Trial On Agnikarma And Jalaukavacharana In Janu Sandhigata Vata With Specail Reference To 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 |
Dr Suman Kumari |
| 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
Jaipur
RAJASTHAN
302002
India |
| Phone |
6375063226 |
| Fax |
|
| Email |
dr.meenasuman08294@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrManorma SIngh |
| Designation |
Assistant 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
Jaipur
RAJASTHAN
302002
India |
| Phone |
7414810997 |
| Fax |
|
| Email |
docmanorma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrManorma SIngh |
| Designation |
Assistant 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
RAJASTHAN
302002
India |
| Phone |
7414810997 |
| Fax |
|
| Email |
docmanorma@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda ,Jaipur |
|
|
Primary Sponsor
|
| Name |
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 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSuman Kumari |
NIA Hospital |
Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be University (De-Novo),Jorawar Singh Gate,Amer Road,Jaipur,Rajasthan
Jaipur
RAJASTHAN |
06375063226
dr.meenasuman08294@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma अिfकम | (Procedure Reference: 5.Sushruta Samhita, edited with Ayurved Tattva-Sandipika hindi commentary of Kaviraj Ambikadatt Shastri, Sutran Sthan 28/37. Chaukhamba Sanskrit Sansthan Varanasi edition reprint 2017; page nकà¥à¤°à¥à¤¯à¤¾à¤¤à¥à¤¸à¤¨à¥à¤§à¤¿à¤—ते वाते दाहसà¥à¤¨à¥‡à¤¹à¥‹à¤ªà¤¨à¤¾à¤¹à¤¨à¤®à¥. || (B.P.Chi.24/259)o. 52, Procedure details: Procedure of Agnikarma done once a day
Patient will be advised to take Pichhila Anna prior to the procedure.
After taking patient in a suitable position, Agnikarma will be done with thermal cautery, after making it red hot. Bindu type of Dagdha will be done on the most tender spots till Samyak Twak Dagdha Lakshanas are achieved.
Immediately after completion of the procedure, Ghrit Kumari Pulp will be applied over the Vrana followed by topical application of Madhuyasti Churna mixed with Ghrut)
| | 2 | Comparator Arm | Procedure | - | jalaukAvacaraNam जलौकावचरणम | (Procedure Reference: BHAVPRAKASHA, Edited with Vidyotini Hindi Commentry of PandiT Sri Brahma Sankara Misra,Chikitsa Sthana,Chaukhamba Sanskrit Sansthan Varanasi edition ;page no. 265 ï¬à¤°à¥à¤—à¥à¤¦à¤¾à¤¹à¤¶à¥‚लतोदारà¥à¤¤à¤¾à¤¦à¤¸à¥ƒà¤•à¥ सà¥à¤°à¤¾à¤µà¥à¤¯à¤‚ जलौकसा | (च.चि. 29/37), Procedure details: Jalauka should be activated by keeping them in water mixed with Haridra paste. The site of application should be cleaned and rubbed with Gomaya Churna. After detachment, a topical application of honey and sterile bandage should be applied. Jalauka will be made to vomit blood by applying Saindhav Lavana on its mouth and by squeezing it gently from tail towards head. This procedure is done once a day at an interval of 7 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age : Patients of either gender between age 50 -70 yrs.
1. Grade 0 to Grade 3 as per Kellgren and lawrence classification system.
2. Positive Radio-logical findings upto grade 3.
3. With typical clinical classical features of Janu Sandhigata Vata and OA Knee |
|
| ExclusionCriteria |
| Details |
Rheumatoid arthritis, Gouty arthritis, osteomyelitis and septic arthritis of knee joints.
1. Patients with local infection or skin diseases on the proposed site of Agnikarma or Jalauka Avcharana.
2. Patients suffering from cardiovascular diseases, HIV, hepatitis, hypertension, anemia and bleeding disorders.
3. Contraindications for Agnikarma.
4. Contraindications for Raktamokshana Karma.
5. History of trauma to knee joint.
6. History of surgical intervention on knee joint. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in WOMAC scale. |
51days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of patient satisfaction criteria after the intervention. |
51 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/05/2023 |
| 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 any |
|
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 30 participants will be selected after details examination and divided in 2 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 ,14 th day , 21 st day ,follow up for next 4 weeks ( 15 days interval ). |