| CTRI Number |
CTRI/2016/04/006848 [Registered on: 19/04/2016] Trial Registered Retrospectively |
| Last Modified On: |
19/04/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [External application] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
External application of Siddha medicine- Moosambara patru on Mootu veekam (Swollen Knee joint) – Short term Clinical Trial |
|
Scientific Title of Study
|
External application of Siddha medicine- Moosambara patru on Mootu veekam (Swollen Knee joint) – Short term Clinical Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAKanagarajan |
| Designation |
Research Officer(Siddha) |
| Affiliation |
SiddhaClinicalResearchUnit |
| Address |
SiddhaClinicalResearchUnit
GovernmentSiddhaMedicalCollege campus
Palayamkottai
Tirunelveli District
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442178440 |
| Fax |
04622573736 |
| Email |
crusiddha.palay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrHMubarak |
| Designation |
Senior Research Fellow(Siddha) |
| Affiliation |
SiddhaClinicalResearchUnit |
| Address |
SiddhaClinicalResearchUnit
GovernmentSiddha Medical Collegecampus
Palayamkottai
Tirunelveli District
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9994133214 |
| Fax |
04622573736 |
| Email |
mubarak.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrHMubarak |
| Designation |
Senior Research Fellow(Siddha) |
| Affiliation |
SiddhaClinicalResearchUnit |
| Address |
SiddhaClinicalResearchUnit
GovernmentSiddha Medical Collegecampus
Palayamkottai
Tirunelveli District
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9994133214 |
| Fax |
04622573736 |
| Email |
mubarak.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Siddha |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Siddha |
| Address |
Central Council for Research in Siddha,
Ministry of AYUSH,
Government Anna Hospital, SCRI Campus,
Arumbakkam,
Chennai 106
|
| Type of Sponsor |
Research institution |
|
|
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 |
| DrAKanagarajan |
Siddha Clinical Research Unit |
Siddha Clinical Research Unit,
Government Siddha Medical College campus,
Palayamkottai,
Tirunelveli 627002
Fax: 0462 2573736
Tirunelveli
TAMIL NADU |
9442178440
04622573736
crusiddha.palay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe of SCRU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Swollen Knee joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Moosambara patru(Siddha Medicine) |
Powder form drug mixed with egg white and applied over the affected knee joints |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 40 years to 65 years
2. Patients with knee joint swelling
(Single or Both knees)
3. Pain
4. Joint tenderness
5. Patients willing to give consent to participate in the trial
|
|
| ExclusionCriteria |
| Details |
1. Age less than 40 years or more than 65 years
2. Patients with Diabetes mellitus/ Hepatic failure/
Renal failure,
3. Any serious underlying infectious conditions and
Hematoma
4. History of surgical interventions
5. Patients not willing to give consent to participate in the trial
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the changes in the swelling of the subjects by measuring the circumference of the affected joint before and after treatment
|
To assess the changes in the swelling of the subjects by measuring the circumference of the affected joint before and after treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety of the trial drug while applying externally
|
To assess the safety of the trial drug while applying externally
|
|
|
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)
|
28/02/2015 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Based on the Case sheet proforma the trial subjects were
recruited for the trial. At first they were sent for screening whether to confirm
the diagnosis. The consent forms signed by the patients were collected and the
Patient information sheet was given as per the ethical guidelines. They were
asked to report to the Investigators every 5days once for a consecutive period
of 15days. The recruited patients were enrolled in the register. The
investigations were advised as per the protocol. The Moosambara patru25 g of
medicine was given to the patients with subject I.D
nos. They were asked to Applied the medicine in swollen joint for 5 days mixed
with White Egg yolk as a External therapy .And every visit measuring the swollen knee joints with help
of non elastic inch tap, before and after treatments. Every five days once
Measurements were done consecutively for a period of 15days treatment.
The data generated maintained in the excel sheet.
|