| CTRI Number |
CTRI/2024/05/067010 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia
Other (Specify) [Agnikarma] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pain management by Agnikarma. |
|
Scientific Title of Study
|
Clinical efficacy on Agnikarma with Swarna shalaka in the management of Janusandhigata Vata Wsr to Osteoarthritis of knee joint. |
| 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 Satya Narayan Sahani |
| Designation |
MS Scholar |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya Puri Odisha |
| Address |
Post Graduate Department of Shalya Tantra
Gopabandhu Ayurveda Mahavidyalaya
Puri
ORISSA
752002
India |
| Phone |
9439779151 |
| Fax |
|
| Email |
drsatyasahani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ranjan Kumar Kasta |
| Designation |
Professor and HOD |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri |
| Address |
Post Graduate Department of Shalya Tantra
Gopabandhu Ayurveda Mahavidyalaya Puri Odisha
Puri
ORISSA
752002
India |
| Phone |
9439809240 |
| Fax |
|
| Email |
drrkkasta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Ranjan Kumar Kasta |
| Designation |
Professor and HOD |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri |
| Address |
Post Graduate Department of Shalya Tantra
Gopabandhu Ayurveda Mahavidyalaya Puri Odisha
Puri
ORISSA
752002
India |
| Phone |
9439809240 |
| Fax |
|
| Email |
drrkkasta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gopabandhu Ayurveda Mahavidyalaya Puri Odisha |
|
|
Primary Sponsor
|
| Name |
Dr Satya Narayan Sahani |
| Address |
Post Graduate Department of Shalya Tanta
Gopbandhu Ayurveda Mahavidyalaya Puri Odisha 752002 |
| 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 |
| Prof Dr Ranjan Kumar Kasta |
Gopabandhu Ayurveda Mahavidyalaya Puri Odisha 752002 |
Opd and Ipd of Post Graduate Department of Shalya Tantra Puri
752002
Puri
ORISSA |
9439809240
drrkkasta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Gopabandhu Ayurveda Mahavidyalaya and Hospital Puri Odisha- 752002 |
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 | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Samhita, Procedure details: Agnikarma in Janu sandhigatavata in maximum tender point in every 7 days gap for 28 days for reduction of pain.)
|
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Janu Sandhigata Vata
Age from 45 to 70 yeas
Patients of either group
Patients without any anatomical deformity |
|
| ExclusionCriteria |
| Details |
Patient below 45yr and above 70 yrs.
Patient suffering from disease like Diabetes Carcinoma Rheumatoid arthritis and Tuberculosis.
Pregnant Women.
AIDS Hepatitis B |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess pain management in Janusandhigata Vata. |
Four sitting in a gap of 7days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess day by day reduction of pain by the application of Agnikarma. |
30 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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="0"
Days="28" |
|
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
|
Total 40 patients will be selected for the study. It will be Single group clinical study. The procedure will be performed in three stages as Purva Karma, Pradhan Karma and Paschat Karma mentioned by Acharya Sushrut. |