| CTRI Number |
CTRI/2018/09/015837 [Registered on: 26/09/2018] Trial Registered Prospectively |
| Last Modified On: |
27/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [Varmam] |
| Study Design |
Other |
|
Public Title of Study
|
Treatment for Knee joint ligament injury through Siddha system of medicine. |
|
Scientific Title of Study
|
Comparative clinical trial of Siddha drugs Vithu Rasa Mezhugu internally and Murivu Ennai externally in the treatment of Muzhangal Mootu Savvu Kayangal
(Ligament Injury)with and without Varmam therapy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monika M |
| Designation |
Pg scholar |
| Affiliation |
National Institute of Siddha. |
| Address |
National Institute of Siddha,
Tambaram sanatorium,
Chennai-47,
Tamil Nadu.
Raja silks,
Uranipuram(po),
Orathanadu(tk),
Tanjavur(dt)
614614
Chennai
TAMIL NADU
600047
India |
| Phone |
8056367363 |
| Fax |
|
| Email |
text2moni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mahalakshmi MDs |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha,
Tambaram sanatorium,
Chennai-47,
Tamil Nadu.
-
Chennai
TAMIL NADU
600047
India |
| Phone |
9444519975 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Mahalakshmi MDs |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha,
Tambaram sanatorium,
Chennai-47,
Tamil Nadu.
-
Chennai
TAMIL NADU
600047
India |
| Phone |
9444519975 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,
Tambaram sanatorium,
Chennai-47 |
|
|
Primary Sponsor
|
| Name |
Dr Monika M |
| Address |
National Institute of Siddha,
Tambaram sanatorium,
Chennai-47 |
| 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 |
| DrMonikaM |
Department of Sirappu Maruthuvam |
Ayothidoss pandithar hospital,
National Institute of Siddha,
Tambaram sanatorium.
Kancheepuram
TAMIL NADU |
8056367363
text2moni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B108||Other human herpesvirus infection, (2) ICD-10 Condition: M70-M79||Other soft tissue disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vithu Rasa Mezhugu
Murivu Ennai
Varmam |
Vithu Rasa Mezhugu (Internally)
Murivu Ennai (Externally)
Varmam external therapy |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Pain and tenderness, often sudden and severe in the knee joints
Pain get worse while walking
swelling present in the knee joints
a feeling of looseness in the knee joints
patient willing to undergo radiological investigations and laboratory investigations
|
|
| ExclusionCriteria |
| Details |
Complete ligament tear of the knee joint
Posterior cruciate ligament tear
Evidence of bony fractures in X-rays
H/o Cardiac diseases
H/o Diabetes mellitus
H/o Rheumatoid arthritis
H/o Chronic kidney disease
Pregnancy and lactation
Septic arthritis
Gonococcal arthritis
Psoriatic arthritis
Patient with 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 |
| To relieve the pain nd it will be assessed by Koos knee survey. |
1-48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/09/2018 |
| 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="5"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primary objective of this study is to evaluate the therapeutic efficacy of siddha drugs Vithu Rasa Mezhugu (internal) and Murivu Ennai (external) in reducing the pain and restricted movements n the treatment of Muzhangal Mootu Savvu Kayangal (Ligament injury-knee joint) with and without varmam through clinical study. |