| CTRI Number |
CTRI/2024/02/063276 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2024 |
| 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
|
Sun gazing and acupuncture for myopia |
|
Scientific Title of Study
|
Combination of Sun Gazing and Acupuncture for Myopia - A Pilot Randomized Controlled Trial |
| Trial Acronym |
A Randomized Controlled Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyothi KV |
| Designation |
MD Scholar |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Alvas College of Naturopathy and Yogic Sciences Room Number 9,
Department of Clinical Naturopathy
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9995333677 |
| Fax |
|
| Email |
drjyothikv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmeesh DR |
| Designation |
Associate Professor |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Alvas College of Naturopathy and Yogic Sciences Room Number 9,
Department of Clinical Naturopathy
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
7674872784 |
| Fax |
|
| Email |
drlakshmeesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajna |
| Designation |
Associate Professor |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Alvas College of Naturopathy and Yogic Sciences Room Number 9,
Department of Clinical Naturopathy
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
8151824315 |
| Fax |
|
| Email |
prajnamruth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College of Naturopathy and Yogic Sciences, Shobhavana Campus, Mijar, Moodbidri 574225 |
|
|
Primary Sponsor
|
| Name |
Dr Jyothi KV |
| Address |
Alvas college of
Naturopathy and Yogic
sciences, Room 3, Department of
Clinical Naturopathy.
Dakshina Kannada
KARNATAKA
|
| 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 Jyothi KV |
Alvas College of Naturopathy and Yogic Sciences |
Room 3, Department of
Clinical Naturopathy.
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9995333677
drjyothikv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Human Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H542||Low vision, both eyes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
acupuncture |
Control group will be receiving acupuncture for 15 days for 20 minutes.
. Acupuncture session the following points will be used GB 37, St 2, St 36, St 8, Sp 6, GB 16, LI 4, UB2, SJ 23.
the needles used here are sterile and disposable needles |
| Intervention |
sun gazing and acupuncture |
. Experiment group will be receiving sun gazing for 30 days and acupuncture for 15 days for 20 minutes.
.Sun gazing is at sun set time
.for Acupuncture session the following points will be used GB 37, St 2, St 36, St 8, Sp 6, GB 16, LI 4, UB2, SJ 23.
the needles used here are sterile and disposable needles |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Age -18 to 25 years.
2. Both Male and Female patients who are pre-diagnosed mild to moderate myopia (0 D to −6.0 D)
3. Subjects who are willing to participate in the study by signing an appraised consent form.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who have known allergic reactions to sun exposure
2. subjects with diopter measurement less than -0.6 D
3. Subjects with pathologic myopia related fundus changes or significant vision loss
4. subjects with any other eye related diseases other than myopia
5. those who have history of psychiatric lenses
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. measure the changes in the diopter
|
assessment done at two time points
1. Pre assessment: Day 0 before intervention
2. Post assessment : Day 30
after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To measure visual acuity |
assessment done at two time points
1. Pre assessment: Day 0 before intervention
2. Post assessment : Day 30
after intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="8"
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
|
- Myopia is defined as a “refractive error in which rays of light entering the eye parallel to the optic axis are brought to a focus in front of the retina when ocular accommodation is relaxed.
- Myopia is commonly seen in younger population with an estimated global prevalence of myopia is increasing by nearly 25%
- Naturopathic medicine is defined “as a drugless, non-invasive, rational and evidence-based system of medicine imparting treatments with natural elements based on the theories of vitality, toxemia and the self-healing capacity of the body, as well as the principles of healthy living.
- Heliotherapy is one of the important treatment modalities used in naturopathic medicine. Sun therapy, also known as heliotherapy is a process of exposing the body to sun light.
- Sun gazing is a technique where the individual is gazing at the non harmful rays of the sun for a specified time.
- Acupuncture a form of complementary medicine in which fine needles are inserted in the skin at specific points along what are considered to be lines of energy, used in the treatment of various physical and mental conditions.
- A Pilot Randomized Controlled Trail for a period of 30 days with a sample size 60 subjects 30 participants in each group.
- Grouping will be randomized in to experimental and control group with an allocation ration of 1:1
- The experimental group will be receiving the intervention i.e., sun gazing and acupuncture for 15 days each respectively while the control group will be receiving acupuncture as intervention for 15 days
- Pre and post assessment of the subjects using Auto refractometer for diopter measurement and Snellens chart for visual acuity will be done.
|