| CTRI Number |
CTRI/2024/04/066271 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of acupuncture on dry eye disease |
|
Scientific Title of Study
|
A Randomised Controlled Trial To Evaluate the efficacy of Scalp Acupuncture on Keratoconjunctivitis Sicca |
| 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 V Madhumitha |
| Designation |
PG Scholar |
| Affiliation |
TN Dr. M.G.R Medical University, Chennai |
| Address |
Faculty Block, First Floor,International Institute of Yoga and Naturopathy Medical Sciences
184/4, Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8110032272 |
| Fax |
|
| Email |
mmitha598@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Prabu |
| Designation |
AMO |
| Affiliation |
TN Dr. M.G.R Medical University, Chennai |
| Address |
Faculty block, first Floor, International Institute of Yoga and Naturopathy Medical Sciences
184/4, Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9566351891 |
| Fax |
|
| Email |
drprabubnys91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Madhumitha |
| Designation |
PG SCHOLAR |
| Affiliation |
TN Dr. M.G.R Medical University, Chennai |
| Address |
International Institute of Yoga and Naturopathy Medical Sciences
184/4, Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8110032272 |
| Fax |
|
| Email |
mmitha598@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Tamilnadu -603001, India |
|
|
Primary Sponsor
|
| Name |
Dr V Madhumitha |
| Address |
184/4, International Institute of Naturopathy and Yoga Medical Sciences, Kamarajar Nagar, Chengalpattu, Tamilnadu - 603001 |
| 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 V Madhumitha |
International Institute of Naturopathy and Yoga Medical Sciences |
OPD department, Ground Floor,184/4 , Kamarajar Nagar, Chengalpattu - 603001
Kancheepuram
TAMIL NADU |
8110032272
mmitha598@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpttu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H162||Keratoconjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Scalp Acupuncture |
patient undergoes scalp acupuncture needling at MS-13 bilaterally for 30 minutes in a session, thrice a week for a month |
| Comparator Agent |
WAITLIST |
Patient will take rest for a period of one month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to give consent |
|
| ExclusionCriteria |
| Details |
1. Patients with defect of eyelid/eyelashes.
2. Past history of surgical eye operations in the last 3months.
3. Pregnancy, lactation or women planning pregnancy.
4. Eye ball or ocular appendage injuries.
5. Active ocular infections.
6. Diabetic retinopathy, cataract, or glaucoma.
7. Taking systemic corticosteroids or immunosuppressant treatment.
8. Needle phobia.
9. Any injuries on the scalp where needle would be inserted.
10. Others considered ineligible by investigator. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of tear production by Schirmer tear test |
baseline, 4weeks, 8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Ocular Surface Disease Index |
baseline, 4weeks, 8weeks |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
03/06/2024 |
| 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="1"
Days="30" |
|
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-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - online
- For how long will this data be available start date provided 17-06-2024 and end date provided 17-08-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Keratoconjunctivitis sicca (KS), or dry eye syndrome is a disorder affecting the homeostasis of tear film, causing symptoms in eyes that may affect the quality of life in people. The prevalence of KS in India is approximated to be 5% to 35%. The study group will undergo scalp acupuncture needling at MS-13 bilaterally with stainless steel, sterile needles of length 1tsun and diameter of 28-30 gauge will be used for 12times, thrice a week for a month, while the control group would be waitlisted without any intervention until the study is completed. MS -13 points has been selected as this corresponds to the visual area in scalp acupuncture. The primary outcome is The Schirmers tear test (SIT) is used to assess tear production. The Secondary outcome is Ocular Surface Disease Index (OSDI) for the assessment of symptoms related to dry eye disease and their effect on vision. The assessment will be checked on baseline, after 4weeks and 8 weeks.
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