| CTRI Number |
CTRI/2023/08/056965 [Registered on: 28/08/2023] Trial Registered Prospectively |
| Last Modified On: |
26/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [Therapeutic ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on vasambu patru for Osteoarthritis-knee patients. |
|
Scientific Title of Study
|
Clinical evaluation of vasambu patru(poultice) in the management of Azhal keelvaayu(Osteoarthritis-knee)- A pilot study |
| 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 A Adlin Reshma |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai |
| Address |
Department of pura maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai-106, Tamilnadu.
Chennai
TAMIL NADU
600106
India |
| Phone |
08608778215 |
| Fax |
|
| Email |
adlinreshma2910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Kannan |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai-106. |
| Address |
Department of pura maruthuvam, Government Siddha Medical College, Arumbakkam,Chennai-106, Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9444216514 |
| Fax |
|
| Email |
vmkkannan2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Kannan |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai-106. |
| Address |
Department of pura maruthuvam, Government Siddha Medical College, Arumbakkam,Chennai-106, Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9444216514 |
| Fax |
|
| Email |
vmkkannan2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Arignar Anna Government Siddha Medical College, No-6 Anna Arch Road, Arumbakkam,
Chennai, 600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College, Chennai |
| Address |
No-6 Anna Arch Road,NSK Nagar, Arumbakkam, Chennai-600106 |
| Type of Sponsor |
Government medical college |
|
|
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 A Adlin Reshma |
Government Siddha Medical College, Arumbakkam, Chennai |
Department of pura maruthuvam, Op No 14, Aringar Anna Government Hospital and Homeopathy Medicine,Arumbakkam, Chennai-106.
Chennai
TAMIL NADU |
8608778215
adlinreshma2910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Siddha Medical College,Arumbakkam, Chennai . |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
VASAMBU PATRU (EXTERNAL) |
Vasambu and kaachukatti will be administered externally as Patru (semi-solid poultice)
wherein the mixture of Vasambu, kaachukatti and water will be applied in the affected knee.Therapy duration is 15 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Pain & swelling in the knee joint
Early morning stiffness (less than <15 mins)
Reduced range of motion in the knee joint. |
|
| ExclusionCriteria |
| Details |
Rheumatoid Arthritis
Psoriatic arthropathy
Systemic lupus erythematous
Progressive systemic sclerosis
Gouty Arthritis
Septic Arthritis
Fracture
Any other serious systemic illness
Pregnant & lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess reduction in clinical symptoms after the treatment
and assessing the improvement of the patient through Visual Analogue Scale & Range of Motion evaluation chart. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access range of motion after treatment |
15 days |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
04/09/2023 |
| 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="3"
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 is an open clinical evaluation of Vasambu patru (semisolid poultice) in the management of Azhal keelvaayu (Osteoarthritis-knee)-a pilot study.Vasambu and kaachukatti will be administered externally as Patru (semi-solid poultice) wherein the mixture of Vasambu, kaachukatti and water will be applied in the affected knee joint. Duration of this therapy is 15 days. Sample size for the study is 10.The trial drug Vasambu patru contain certain active herbs that possesses analgesic and anti-inflammatory activities which will be helpful to reduce symptoms of Osteoarthritis-knee. This study is designed to assess reduction in clinical symptoms after the treatment and assessing the improvement of the patient through Visual Analogue Scale and Range of Motion evaluation chart. |