| CTRI Number |
CTRI/2024/05/066774 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Odivu kattum pasai for Padangaal enbu murivu |
|
Scientific Title of Study
|
An open single arm clinical trial to determine the therapeutic effectiveness of odivu kattum pasai in the treatment of padangaal enbu murivu (meta tarsal fracture) |
| Trial Acronym |
OKP-odivu kattum pasai |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Menaka |
| Designation |
MD Siddha |
| Affiliation |
National institute of siddha |
| Address |
Room no 14
Department of Puramaruthuvam
National institute of siddha Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7010251672 |
| Fax |
|
| Email |
menakaravi1059@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M V Mahadevan |
| Designation |
Associate Professor |
| Affiliation |
National institute of siddha |
| Address |
Room no 14
Department of Puramaruthuvam
National institute of siddha
Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9840417565 |
| Fax |
|
| Email |
puramaruthuvam@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
M V Mahadevan |
| Designation |
Associate Professor |
| Affiliation |
National institute of siddha |
| Address |
Room no 14
Department of Puramaruthuvam
National institute of siddha
Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9840417565 |
| Fax |
|
| Email |
puramaruthuvam@gmai.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss pandithar hospital
National institute of siddha
tambaram sanatorium- 600047
kancheepuram district
tamilnadu |
|
|
Primary Sponsor
|
| Name |
R Menaka |
| Address |
Room no 14
Department of Pura maruthuvam
National institute of siddha
Tambaram Sanatorium-600047
kanchipuram district |
| 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 R Menaka |
Ayothidoss pandithar hospital |
Room no 14
Department of Pura maruthuvam
National institute of siddha
tambaram sanatorium-600047
Kancheepuram
TAMIL NADU |
7010251672
menakaravi1059@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M843||Stress fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Odivu kattum pasai for Padangaal enbu murivu |
Dose:Sufficient quantity
Frequency:3 days once
Duration:48 days external application |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient reporting with history of Meta tarsal fracture within 15 days of trauma
Patients willing to undergo radiological investigation
Patient willing to sign the informed consent stating that he/she will consciously stick to the treatment but can opt out of the trial of his/her own conscious discretion |
|
| ExclusionCriteria |
| Details |
Open fracture
Comminuted fracture
Foot ulcers
Fracture with malunion
Un Controlled Diabetes Mellitus
K/H/O Hypertension
K/H/O Peripheral Neuritis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the therapeutic effectiveness of odivu kattum pasai in the treatment of Padangaal enbu murivu (Meta tarsal fracture) and assess the prognosis of padangaal enbu murivu (Meta tarsal fracture) through AOFAS scale
|
48 days
|
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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="0"
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
|
BACKGROUND:The Siddha system of medicine is one of the
primitive medical systems in India. The Siddha system treats the diseases with
internal & external medicines. They are as important as internal medicines
in the management of health & diseases. They deal with medications &
treatment procedures used both as a main stream and supportive therapy. This
forms an important part of Siddha system as it ensures good effects.Bone setting is one of the specialities in siddha
system of medicine. Majority of the people suffering from bone fractures are
being treated successfully by this cost- effective and time-tested method.In siddha medicine, Kattu is the application of medicine made of
botanicals, inorganic substances(etc).to the affected area and bandaged. Pasai
is emollient and protective, but stay on the skin longer. This tenacity will
have a warming effect locally. Pasai is applied on the fracture of metatarsal
bone and bandaged. A fracture can be caused by either direct violence or
indirect violence causes a fracture at the site of impact of the force.
Indirect violence is one that is transmitted to a bone away from the site of
impact producing a fracture there. Fracture of the metatarsals are due to
direct violence, the foot being crushed by weighs falling on it.Stress fracture
of metatarsal bone is one of the common forms of stress fracture.The
fracture occurs in new recruits to the army and police due to the unaccustomed
strain on the foot during training.It is also called March fracture or Fatigue
fracture.Jones fracture is caused by severe inversion of the fore foot, when
the foot gets doubled up with the weight falling on it. OBJECTIVE:To determine the
therapeutic effectiveness of odivu kattum pasai in the treatment
of Padangaal enbu murivu (Meta tarsal fracture) and assess the
prognosis of padangaal enbu murivu (Meta tarsal fracture) through AOFAS
scale. STUDY DESIGN:An open randomised clinical trial with a total of 20 diagnosed patients of Padangaal enbu murivu(Meta tarsal fracture) reporting at ayothidoss pandithar hospital national institute of siddha will be enrolled in the study.Patients having history of Open fracture,Comminuted fracture,Foot ulcers,Fracture with malunion,Uncontrolled diabetes mellitus,Hypertension,Peripheral neuritis will be excluded.The trial medicine Odivu kattum pasai as external medicine will be given for 48 days. |