| CTRI Number |
CTRI/2022/02/040117 [Registered on: 08/02/2022] Trial Registered Prospectively |
| Last Modified On: |
11/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Para surgical procedure] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Treatment of Osteoarthritis of knee with Agnikarma |
|
Scientific Title of Study
|
Efficacy of Agnikarma with Panchadhatu Shalaka & Agnikarma with Electrocautery in the Management of Janusandhigata Vata (Osteoarthritis of Knee Joint) – An Open Labelled Randomized Comparative Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KRISHNA RAMSINH RATHOD |
| Designation |
MS Ayurveda scholar |
| Affiliation |
ITRA JAMNAGAR |
| Address |
DEPARTMENT OF SHALYA TANTRA, INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA, PN MARG OPPOSITE CITY-B DIVISIION POLICE STATION JAMNAGAR
DEPARTMENT OF SHALYA TANTRA, INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA,PN MARG OPPOSITE CITY-B DIVISION POLICE STATION JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9427300092 |
| Fax |
|
| Email |
krishna.rathod2225@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR T S DUDHAMAL |
| Designation |
ASSOCIATE PROFESSOR,I/C HOD |
| Affiliation |
ITRA JAMNAGAR |
| Address |
DEPARTMENT OF SHALYA TANTRA 6TH FLOOR, INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA, PN MARG OPPOSITE CITY-B DIVISIION POLICE STATION JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR T S DUDHAMAL |
| Designation |
ASSOCIATE PROFESSOR,I/C HOD |
| Affiliation |
ITRA JAMNAGAR |
| Address |
DEPARTMENT OF SHALYA TANTRA 6TH FLOOR, INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA, PN MARG OPPOSITE CITY-B DIVISIION POLICE STATION JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITRA |
| Address |
INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA, PN MARG OPPOSITE CITY-B DIVISIION POLICE STATION JAMNAGAR |
| 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 |
| Krishna Rathod |
ITRA PG HOSPITAL |
DEPARTMENT OF SHALYA TANTRA 6TH FLOOR, INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA, PN MARG OPPOSITE CITY-B DIVISIION POLICE STATION JAMNAGAR
Jamnagar
GUJARAT |
9427300092
krishna.rathod2225@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ITRA JAMNAGAR |
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: JANUSANDHIGATAVATA, |
|
|
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: Bindu dagdha agnikarma will do at affected knee joint with help of panchdhatu shalaka. total 4 sittings of agnikarma do at interval of 7 days.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | electro cautery agnikarma | agnikarma do with help of monopolar electro cautery prob at affected knee joint. total 4 sittings do at interval of 7 days. |
|
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Janusandhigata Vata (O.A. of knee joint)
Patient indicated for Agnikarma as per classics (severe pain at Janusandhi)
|
|
| ExclusionCriteria |
| Details |
Patients of Diabetes mellitus, R.A. (Rheumatoid Arthritis) positive, Gouty arthritis, Gross Knee Joint Effusion.
Other Diseases like Paralysis, Parkinson’s disease, cardiac diseases, pacemaker in situ, renal diseases and endocrine diseases, severe Anemia, and malignancy.
Pregnant and Lactating females.
Known cases of secondary O.A. due to T.B., Syphilis, AIDS, Leprosy etc.
Patients contraindicated for Agnikarma as per classics-Pitta Prakruti Rogi, Durbala (weak), Bheeru (afraid), Sharad and Grishma Ritu.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relief in sign and symptoms |
assess after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase quality of life style |
12 weeks |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/02/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The presenr clinical trial is an open labelled randomized control clinical trial on Janusandhigata Vata (O.A. Knee).In this study total 30 patients will be registered and divided into 2 groups with minimum 15 patients in each group. The interventional group A will receive Agnikarma by Panchadhatu Shalaka and group B will receive Agnikarma by Electrocautery. Total duration of study is 4 weeks with follow up after 8 weeks. |