| CTRI Number |
CTRI/2025/02/080903 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial to Determine the Therapeutic effect of Varmam Manipulation Technique with Vasavaathi thailam (External) for The Management of Lateral Epicondylitis-Tennis Elbow) |
|
Scientific Title of Study
|
An Open Single Arm Clinical Trial to Determine the Therapeutic effect of Varmam Manipulation Technique with Vasavaathi thailam (External) for The Management of Puramuli Thaabitham (Lateral Epicondylitis-Tennis Elbow) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayachitra K |
| Designation |
PG scholar |
| Affiliation |
National Institute of Siddha |
| Address |
OP Room no.15,Department of Varma Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Chennai, Kancheepuram,TamilNadu 600047 India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8428620829 |
| Fax |
|
| Email |
jayachitra10041999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M V Mahadevan |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
OP Room no.14, HOD Department of Pura Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Chennai, Kancheepuram,TamilNadu 600047 India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9840417565 |
| Fax |
|
| Email |
puramaruthuvam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M V Mahadevan |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
OP Room no.14, HOD Department of Pura Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Chennai, Kancheepuram,TamilNadu 600047 India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9840417565 |
| Fax |
|
| Email |
puramaruthuvam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital, National institute of Siddha, Tambaram sanatorium kancheepuram district Chennai 600047 |
|
|
Primary Sponsor
|
| Name |
National institute of Siddha |
| Address |
OP Room no.15,Department of Varma Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Chennai, Kancheepuram,TamilNadu 600047 India |
| 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 |
| Dr Jayachitra K |
Ayothidoss Pandithar Hospital |
OP Room no.15,Department of Varma Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Chennai, Kancheepuram,TamilNadu 600047 India
Kancheepuram
TAMIL NADU |
08428620829
jayachitra10041999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF SIDDHA CHENNAI -600 047 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M771||Lateral epicondylitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Varmam manipulation technique with Vasavaathi thailam for the management of Puramuli thaabitham ( Lateral epicondylitis- Tennis elbow) |
Varmam manipulation technique with Vasavaathi thailam for the management of Puramuli thaabitham (Lateral epicondylitis- Tennis elbow) for 14 sittings weekly twice for 7 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants with pain, tenderness, stiffness in the lateral side of elbow joint.
Participants with positive response in the following provocative tests Mills test, Cozens test, Maudsley test. (15)
Participants with the symptoms of lateral epicondylitis for the time period of greater than 4 weeks to 6 months.
Based on PRTEE Questionnaire, participants with score range of 40 to 80 of total score 100.
|
|
| ExclusionCriteria |
| Details |
Musculoskeletal conditions like Inflammatory and Infective arthritis, Dislocations and deformities in upper extremities, Myositis ossificans etc.
Nerve entrapment condition of upper limb.
History of trauma, fracture and surgical procedure in upper limb.
Uncontrolled Diabetes Mellitus.
Pregnant and lactating women.
Any other serious systemic illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of Patient Related Tennis Elbow Evaluation Questionnaire (PRTEE) score from the baseline assessment.
For clinical significance defined as ‘little better’ the MCID of total PRTEE score is 7 points or 22% of baseline score.
For clinical significance defined as ‘completely recovered’ the MCID of total PRTEE score is 11 points or 37% of baseline score.
|
49 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
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 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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="0"
Months="6"
Days="0" |
|
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
|
An open single arm clinical trial to determine the therapeutic effect of varmam manipulation technique with vasavaathi thailam for the management of Puramuli thaabitham (Lateral epicondylitis -Tennis elbow )will be carried out for 49 days in Varma maruthuvam OPD,Ayothidoss pandithar hospital,National institute of siddha with 30 patients as sample size.The patients will be non randomly selected based on inclusion and exclusion criteria for enrollment in the study and treated with 14 sittings of varmam manipulation technique-varma thadaval weekly twice for 7 weeks. Prognosis will be documented in the appropriate forms enclosed in the protocol. The outcome of the study will be assessed by the PRTEE score before and after treatment and the results will be statistically analysed. |