| CTRI Number |
CTRI/2024/06/068801 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effectiveness of Varmam manipulation technique with Murivu Ennai (External medicine) for the management of Anterior Cruciate Ligament Injury |
|
Scientific Title of Study
|
An open clinical trial to evaluate the therapeutic effectiveness of Murivu Ennai (External) for the management of Muzhangal Mootu Savvu Kaayam (Anterior Cruciate Ligament Injury) along with Varmam Therapeutic Manipulation
|
| 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 M Fouziya Thasim |
| Designation |
Post graduate scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of varma maruthuvam
National institute of siddha
Tambaram sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
8525824319 |
| Fax |
|
| Email |
fouziyathasim@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr N J Muthukumar |
| Designation |
Director General of CCRS |
| Affiliation |
National Institute of Siddha |
| Address |
Central council for research in siddha
Tambaram sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
7358481734 |
| Fax |
|
| Email |
njmuthukumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr N J Muthukumar |
| Designation |
Director General of CCRS |
| Affiliation |
National Institute of Siddha |
| Address |
Central council for research in siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
7358481734 |
| Fax |
|
| Email |
njmuthukumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram Sanatorium
Chennai 600047
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha Tambaram sanatorium Chennai Tamilnadu |
| 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 M Fouziya Thasim |
National institute of siddha |
Room no: 15
Department of varma maruthuvam
Chennai
TAMIL NADU |
8525824319
fouziyathasim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF SIDDHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Varmam Manipulation With Murivu Ennai |
Varmam Manipulation With Murivu Ennai Weekly once for 70 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ACL Injury Grade 1 and 2 in MRI
Patients willing to undergo radiological investigation.
Patients willing to sign the informed consent form
KOOS score in the range of 0 to 40% |
|
| ExclusionCriteria |
| Details |
Complete Anterior Cruciate ligament tear
Severe Co-morbidities
Pregnant and Lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The reduction in pain and improvement in range of motion of the affected knee after
the treatment with trial drugs will be assessed by KOOS Score. The expected outcome will be
above 60% with KOOS Score. |
At baseline, 10th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="1"
Months="6"
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
|
An
open clinical trial which will be carried out for 18 months in the OPD of
Varmam Maruthuvam, Ayothidoss Pandithar Hospital, National Institute of Siddha
with 20 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 Varma thadaval (Varma manipulation technique) with Murivu
Ennai for the management of Muzhangal Mootu Savvu Kaayam weekly once for 70
days. Prognosis will be documented in the appropriate forms enclosed with the
protocol. Primary outcome of the study is assessed clinically and by the KOOS
survey score and the results will be statiscally analysed |