| CTRI Number |
CTRI/2024/03/064500 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of cold mud pack on eye pressure among healthy individuals |
|
Scientific Title of Study
|
Effect of cold mud pack to eyes on intraocular pressure among healthy individuals- A randomized control 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 |
Dr Nikhil Dilip Patil |
| Designation |
PG Scholar |
| Affiliation |
SDM college of naturopathy and yogic sciences |
| Address |
Room number 2, Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital, Shanthivana, Dharmasthala
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
08762339152 |
| Fax |
|
| Email |
nikhilpats007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujatha K J |
| Designation |
Professor, Dean |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Room number 2, Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences, Ujire, Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
07349424672 |
| Fax |
|
| Email |
drsujathadinesh2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil Dilip Patil |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Room number 2, Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital, Shanthivana, Dharmasthala
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
08762339152 |
| Fax |
|
| Email |
nikhilpats007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara Yoga and Naturecure
hospital Shanthivana, Dharmasthala, Dakshina kannada, karnataka,574216 |
|
|
Primary Sponsor
|
| Name |
Dr. Nikhil D Patil |
| Address |
Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital, Shanthivana, Dharmasthala |
| Type of Sponsor |
Other [SELF] |
|
|
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 Nikhil Dilip Patil |
Siddharth Netralaya |
CTS 4830/1A, 3rd Floor, Dr. B. R. Ambedkar Road, Civil Hospital Rd, Belagavi, Karnataka 590001
Belgaum
KARNATAKA |
08762339152
nikhilpats007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Naturopathy and Yogic sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cold compress |
A wet muslin cloth of rectangular size will be applied over the closed eyes
Duration: 20 minutes |
| Intervention |
Cold mud pack to eyes |
Brown coloured virgin mud was collected from 3 feet below the ground level. The
collected mud was freed from impurities, composts, or pebbles. The mud was
finely sieved. It was stored under direct sunlight. Sufficient quantity of cold water
was added to the mud to make it a pasty like substance. The pasty like mud was
applied up to one inch thickness in the middle of a flannel of wet muslin cloth of
suitable rectangular size and wrapped on all sides and kept ready in a tray.
the entire mud pack is in contact with the skin and
over the closed eyes.
Duration: 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1) Those willing to provide written informed consent to participate in the study
2) All cases who had no previous exposure to the mud packs and
3) Those who were under nourished |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intra ocular pressure |
Baseline and immediately after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
29/03/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Naturopathy is a rational and evidence-based system of medicine imparting
treatment to natural elements based on the theories of vitality, toxaemia, and the
self-healing capacity of the body and the principles of healthy living. Indian
Naturopathy includes Yoga along with some ancient Indian concepts like –
‘Panchabhuta based understanding of health and disease.[1] Among these five
elements, the earth is an integral component of the human body and has a
specific effect on health and disease.
Mud pack is used to treat conditions like fever, diarrhea, pile, dysentery,
constipation, anxiety, conjunctivitis, headache, allergy, and errors of refraction in
the eyes.
The beneficial results are brought about because the cool moisture in and under
the pack relaxes the pores of the skin, draws the blood to the surface, relieves
inner congestion, pain, and promotes heat, radiation and elimination of morbid
matter. Although mud pack have been used extensively for various conditions, the
actual mechanism of how a mud bath works remains unclear. The aim of the
study is to examine the influence of simultaneous application of cold mud pack
on the abdomen and eyes on the cardiac autonomic regulation. The objectives of
the study are to study the influence of cold mud pack on the change of intraocular pressure |