| CTRI Number |
CTRI/2025/03/081850 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can Acupuncture on the Back Help Nearsightedness? A Study with Young Adults: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Efficacy of Urinary Bladder (UB 2, 9, 10) acupuncture points on myopia in young adults: 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 Yogapriya R |
| Designation |
PG Scholar |
| Affiliation |
International Institute Of Yoga And Naturopathy Medical Sciences |
| Address |
Department of Acupuncture and Energy Medicine International Institute Of Yoga And Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Ammanambakkam, Tamil Nadu 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8940687449 |
| Fax |
|
| Email |
dryogapriyar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geethanjali Shankar |
| Designation |
Head of Department |
| Affiliation |
International Institute Of Yoga And Naturopathy Medical Sciences |
| Address |
Department of Acupuncture and Energy Medicine 184/4 Kamarajar Nagar Chengalpattu Ammanambakkam Tamil Nadu India 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6379377297 |
| Fax |
|
| Email |
drgeethu.nat007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geethanjali Shankar |
| Designation |
Head of Department |
| Affiliation |
International Institute Of Yoga And Naturopathy Medical Sciences |
| Address |
Department of Acupuncture and Energy Medicine 184/4 Kamarajar Nagar Chengalpattu Ammanambakkam Tamil Nadu India 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6379377297 |
| Fax |
|
| Email |
drgeethu.nat007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Naturopathy and Yoga branch 3 Department of Acupuncture and Energy Medicine International Institute Of Yoga And Naturopathy Medical Sciences 184/4, Kamarajar Nagar, Chengalpattu, Ammanambakkam, Tamil Nadu 603001 |
|
|
Primary Sponsor
|
| Name |
International Institute Of Yoga And Naturopathy Medical Sciences |
| Address |
Naturopathy and Yoga Branch3 Department of Acupuncture and Energy Medicine 184/4 Kamarajar Nagar Ammanambakkam Chengalpattu Tamil Nadu India 603001 |
| Type of Sponsor |
Government medical college |
|
|
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 Yogapriya R |
International Institute Of Yoga And Naturopathy Medical Sciences |
Naturopathy and Yoga Branch 3 Acupuncture and Energy medicine 184/4 Kamarajar Nagar Chengalpattu Ammanambakkam Tamil Nadu India 603001
Kancheepuram
TAMIL NADU |
8940687449
dryogapriyar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee International Institute of Yoga and Naturopathy medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupuncture |
Intervention, twice a week with an interval of 3 days for about 8 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
The study included 10 subjects aged 18 to 24 years diagnosed with myopia with a refractive error ranging between –0.5D and –6D (dioptres) Both male and female participants were included, all presenting with symptoms of blurred vision |
|
| ExclusionCriteria |
| Details |
Participants with myopia associated with other ocular diseases (except astigmatism) high myopia or eye infections were excluded Additionally individuals unwilling to participate or those with lesions or scars at the selected acupuncture points were not included in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Refraction is measured using 2 methods
1. Phoropter – subjective method
2. Auto refractor – objective method |
Baseline 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ocular discomforts measured using ocular discomfort analog scale |
Baseline 8 weeks |
|
|
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)
|
28/01/2026 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dryogapriyar@gmail.com].
- For how long will this data be available start date provided 15-12-2026 and end date provided 31-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Myopia is a visual impairment caused by excessive axial elongation or refraction, resulting in parallel rays focusing in front of the retina.The international myopia institute classifies it into low myopia (-0.50 D to >-6.00D), high myopia (> 6.00D) and pre-myopia (+0.75 to >-0.50D in children). Its prevalence is rising, with WHO estimating 314 million cases globally, potentially reaching by 50% by 2050. High myopia increases the risk of glaucoma, retinal detachment and chorioretinal atrophy. Cognitive demands exacerbate refractive errors with many developing myopia by age 25. Acupuncture, targeting specific body points, regulates qi flow reduces pain and enhances muscle strength by stimulating the somatosensory system. Sustained accomodation strains neck and shoulder muscles, causing fatique, headaches and blurred vision. Dry eyes, linked to meibomian gland dysfunction also impair visual acuity. Acupuncture has proven effective in mitigating these symptoms. This study aims to enhance visual acuity using bilateral acupuncture at UB2, UB9 and UB10, addressing challenges faced by young individuals with myopia.
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