| CTRI Number |
CTRI/2024/12/078572 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy comparison study of Jalaukavachara and modified raktamokshana in Knee joint pain |
|
Scientific Title of Study
|
A Clinical Study of Efficacy of Jalaukavacharana in Comparison to Modified Method of Raktamokshana in the management of knee Joint pain of 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 |
Jignesha T Charel |
| Designation |
PhD Scholar,Assistant Professor |
| Affiliation |
Krishna Ayurved Medical College |
| Address |
Krishna Ayurveda Medical College Panchakarma Department,OPD NO:15 Bits Education Campus Vadodara Mumbai NH#8 Varnama Vadodara 391243
Panchakarma Department,OPD NO:15 Bits Education Campus Vadodara
Vadodara
GUJARAT
391243
India |
| Phone |
9664644707 |
| Fax |
|
| Email |
jigicharel504@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalapi Bhogilal Patel |
| Designation |
Principal |
| Affiliation |
J S Ayurved Mahavidyalaya |
| Address |
J S Ayurveda Mahavidyalaya, HOD Panchakarma department Nadiad Gujarat,
HOD Panchakarma department
Vadodara
GUJARAT
387001
India |
| Phone |
09428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalapi Bhogilal Patel |
| Designation |
Principal |
| Affiliation |
J S Ayurved Mahavidyalaya |
| Address |
J S Ayurveda Mahavidyalaya Nadiad Gujarat
HOD Department of Panchakarma
Vadodara
GUJARAT
387001
India |
| Phone |
09428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna Ayurveda Medical College, Davalba Ayurveda Hospital Vadodara |
|
|
Primary Sponsor
|
| Name |
Dr Jignesha Charel |
| Address |
Krishna Ayurveda Medical College Bits Education Campus Vadodara |
| Type of Sponsor |
Other [] |
|
|
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 Jignesha Charel |
Matrusri Davalba Ayurvedic Hospital |
Krishna Ayurvedic Medical College Bits Education Campus Vadodara NH#8 Varnama
Vadodara
GUJARAT |
9664644707
jigicharel504@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethic Committee for Biomedical and Health Research ,Kiran and Pallavi Patel Global University |
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 | - | Modified Raktamokshana | (Procedure Reference: Caraka Sutrasthan 24, Procedure details: Affected area should be done pracchana & negative pressure is given by using cut end of the syringe(0.5ml) Single Time)
| | 2 | Intervention Arm | Procedure | - | JalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Susruta Samhita, Procedure details: Jalaukavacharana - Single time )
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Osteoarthritis of knee joint having pain in affected knee joint |
|
| ExclusionCriteria |
| Details |
1.Patients who are under anticoagulant treatment, suffering from hemophilia or having bleeding tendencies.
2.Patients having increased prothrombin time than normal.
3.Patient having Hb less than 10gm%
4.Patients having other co morbidities like malignancy, uncontrolled diabetes mellitus etc.
5.Patients contraindicated for Raktamokshana
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome will be relief in pain which will be evident by Visual Analogue Scale for Pain. |
single time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms of osteoarthritis and disease in elevated values of blood parameters. ESR etc. |
2 Weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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="1"
Months="0"
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 - NO
|
|
Brief Summary
|
This study is aimed to establish the effectiveness of comparison in between Jaloukavacharana and modified method of raktamokshana on knee joint pain.Trying to find out which procedure is more effective in Knee joint pain.
|