Department of Naturopathy: Govt. Yoga and Naturopathy Medical College Chennai 600 106

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DEPARTMENT OF NATUROPATHY

Govt. Yoga and Naturopathy Medical College


Chennai 600 106

From

Dr.V.Arumugaraj,
Second Year, M.D. Naturopathy,
Government Yoga and Naturopathy Medical College,
Chennai – 600106

To

The Chairman,
Institutional Ethics Committee (IEC),
Government Yoga and Naturopathy Medical College,
Chennai – 600106

Through Proper Channel

Sub: Request for approval from the Institutional Ethics Committee to conduct a
study Title “To evaluate the effectiveness of hot mud application
among chronic periarthritis of shoulder” at Government Yoga and
Naturopathy Medical College Hospital, Chennai.

Respected Sir/ Madam,

As I have proposed to conduct a study “To evaluate the effectiveness


of hot mud application among chronic periarthritis of shoulder” at
Government Yoga and Naturopathy Medical College Hospital - Chennai, I request
for an approval from the Institutional Ethics Committee (IEC). I am herewith
enclosing the details of the project work.
I submit the following undertaking:
 I will start the study after obtaining approval of the Institutional Ethics
Committee (IEC).
 I will get informed consent from patients & maintain confidentiality of details.
 I will carry out the work without detrimental to regular activities as well as
without extra expenditure to the Institution or the Government.
 I will inform the committee in the occurrence of any change in the study
procedure, site, investigation or guide.
 I will not deviate from the area of work for which I have applied for ethical
clearance.
 I will inform the Institutional Ethics Committee immediately, in the occurrence
of any adverse events or serious adverse reactions.
 I will abide by the rules and regulations of the institution.
 I will complete the work within the specified period I have applied for and if
any extension of time is required, I shall apply for permission again and
continue the work.
 I will submit the summary / report of the study / project to the Institutional
Ethics Committee (IEC) on completion.
 I will not claim funds from the institution while doing the work or on
completion.
 I understand that the members of the Institutional Ethics Committee (IEC) have
the right to monitor the study / project without prior intimation.
 I have paid a sum of Rs. 200 towards processing fee.
Thanking You,
Yours Obediently,

Date:
Place: Dr.V.Arumugaraj
Forwarded by:
Guide:
Dr.N.MANAVALAN, N.D.,(OSM), M.A.,(G.T), M.Sc.,(Y&N), P.G.D.Y.,
P.G.D.H.M., P.G.D.H.H.,
H.O.D – Dept. of Naturopathy,
Government Yoga and Naturopathy Medical College,
Chennai – 106.
RECOMMENDATION OF THE HOD

The dissertation / study titled “To evaluate the effectiveness of hot mud

application among chronic periarthritis of shoulder” by

Dr.V.Arumugaraj at Government Yoga and Naturopathy Medical College

Hospital, Chennai will be done according to the regulations of the Institutional

Ethics Committee and I recommend it for acceptance.

Dr. N.MANAVALAN,

N.D.,(OSM), M.A.,(G.T), M.Sc.,(Y&N), P.G.D.Y.,

P.G.D.H.M., P.G.D.H.H.,

HOD-Dept of Naturopathy,
Government Yoga and Naturopathy Medical College,
Chennai – 106

Date:
DETAILS OF THE PROJECT TO BE SUBMITTED BY THE
INDIVIDUAL DESIROUS FOR CLEARANCE FROM
INSTITUTIONAL ETHICS COMMITTEE

SYNOPSIS / SUMMARY

“To evaluate the effectiveness of hot mud


Title application among chronic periarthritis of
shoulder”
To evaluate the effectiveness of hot mud
application on pain and range of motion in
Aim patients with chronic periarthritis of shoulder

To assess the pre test level shoulder pain and


Objectives of the study range of motion among the patients with
periarthritis of shoulder before application of
Hot mud
Primary objective:
To assess the post test level of shoulder pain and
range of motion of the shoulder among patient
with periarthritis of shoulder after application of
Hot mud

To correlate and document the effectiveness of


Hot mud application by pre test and post test level
of shoulder pain among patient with Periarthritis
of shoulders

Study Centre Subjects will be recruited from


Government Yoga and Naturopathy Medical
College Hospital,
Chennai – 600 106

Duration of the Study December 2017 – December 2018

Pre and post Experimental study


Study Design

Methodology Materials:
 Visual analogue scale (SPADI)
 ROM measured by Goniometry

Inclusion Criteria  Age group: 40 to 65 years


 Both sexes
 People who are ready to give their written
consent
 Patients who are having periarthritis of
shoulders
 Receiving no treatments in the last 4 weeks
Participants will be excluded if they have
Exclusion Criteria  History of major shoulder injury or surgery
 Patients with evidence of cervical
radiculopathy, paresis or other neurological
changes in the upper limb on the involved side
 Presence of underlying fracture and
malignancy any mental disorders likely to
interfere with the course or assessment of the
disease process
 HIV infection
 Severe cardiac disease
 Pregnant and lactation

Sample Size  40
Product / Procedure /  Primary investigation of Visual analogue scale
Plan and Goniometer.
 Intervention: Hot mud application to
periarthritis of shoulder daily 20 mints
alternatively for 30 days.
 After 15 days treatment Final investigation of
Visual analogue scale and Goniometer.
Analysis Plan  SPSS method
Sponsorship (Yes/ No)  No
If Yes details
Dr.V.Arumugaraj,
Principle Investigator Post Graduate Student,
Government Yoga and Naturopathy Medical
College,
Chennai – 106
Dr. N MANAVALAN,
N.D.,(OSM), M.A.,(G.T), M.Sc.,(Y&N),
Supervisor and Guide
P.G.D.Y., P.G.D.H.M., P.G.D.H.H.,
H.O.D - Department of Naturopathy,
Government Yoga and Naturopathy Medical
College,
Chennai – 106

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