| CTRI Number |
CTRI/2024/05/067234 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Traditional Chinese Medicine and Palming Techniques in Alleviating Digital Eye Strain |
|
Scientific Title of Study
|
Effectiveness of TCM and Palming Techniques in Alleviating Digital Eye Strain Among Young Female Adults: A Randomized Controlled 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 Dhara Dave |
| Designation |
MD Scholar |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Room number 5, Department of Acupuncture, Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Bairagarh, Bhopal, Madhya Pradesh, 462030.
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9265024915 |
| Fax |
|
| Email |
drdharadave7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavit Bansal |
| Designation |
Assistant Professor, Department of Research |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Research Department, 2nd Floor, Sant Hirdaram Medical College Of Naturopathy and Yogic Sciences, Bairagarh, Bhopal, Madhya Pradesh, 462030.
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7597733931 |
| Fax |
|
| Email |
shmcnys.bhavit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavit Bansal |
| Designation |
Assistant Professor, Department of Research |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Research Department, 2nd Floor, Sant Hirdaram Medical College Of Naturopathy and Yogic Sciences, Bairagarh, Bhopal, Madhya Pradesh, 462030.
MADHYA PRADESH
462030
India |
| Phone |
7597733931 |
| Fax |
|
| Email |
shmcnys.bhavit@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Dhara Dave |
| Address |
A-38, Sant Hirdaram Girls Hostel, Bairagarh, Bhopal, Madhya Pradesh, 462030. |
| 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 Bhavit Bansal |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
Room Number 5, Department of Acupuncture, Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Bairagarh, Bhopal, Madhya Pradesh, 462030.
Bhopal
MADHYA PRADESH |
9265024915
drdharadave7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Sant Hirdaram Medical College of Naturopathy and Yogic Sciencese Sa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Palming Group |
•Group 2, will solely participate in Palming. Palming sessions will be repeated this prescribed Palming procedure every 3 hours for 5 minutes with 6 rounds, upon waking up till before bedtime, consistently for the duration of the 30-day study period.
• Group 3, the control group, will not receive any intervention but they will be fulfilling the inclusion and exclusion criteria.
|
| Intervention |
Traditional Chinese Medicine and Palming Techniques |
• Screening: The Visual Analog Scale (VAS) comprising symptoms associated with digital eye strain will be utilized as the screening tool for participant enrolment and randomization.
• In this study, we have three groups: the TCM and Palming group (Group 1), the Palming group (Group 2), and the control group (Group 3), each consisting of 20 individuals.
• Group 1 will undergo Traditional Chinese Medicine (TCM) treatment in two sessions, each lasting 10 days. During the first session, participants will receive daily 30-minute acupuncture sessions. After a 10-day break, the second session of TCM treatment will commence.
• Additionally, participants in Group 1 will engage in Palming throughout the study period. Palming sessions will be conducted daily for one month, procedure every 3 hours for 5 minutes with 6 rounds, upon waking up till before bedtime, consistently for the duration of the 30-day study period.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Female |
| Details |
1) Participants use digital screens for over 4 hours daily.
2) They experience digital eye strain symptoms ≥ 5 days/week.
3) Participants must consent to participate
|
|
| ExclusionCriteria |
| Details |
1) Exclusion of individuals with diagnosed chronic ocular conditions or recent eye surgery.
2) Pregnant or breastfeeding women are excluded due to hormonal variations.
3) Participants using medication affecting vision within 3 months are excluded.
4) Exclusion of individuals with conditions affecting ocular health or adherence.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To evaluate the effectiveness of TCM therapies in conjunction with palming techniques in reducing symptoms of digital eye strain among young female adults. |
One month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To assess the efficacy of palming techniques alone in mitigating symptoms of digital eye strain among young female adults. |
One month |
|
|
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)
|
25/05/2024 |
| 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
|
- Screening:
The Visual Analog Scale (VAS) comprising symptoms associated with digital
eye strain will be utilized as the screening tool for participant
enrolment and randomization.
·
In this study, we
have three groups: the TCM and Palming group (Group 1), the Palming group
(Group 2), and the control group (Group 3), each consisting of 20 individuals.
·
Group 1 will undergo
Traditional Chinese Medicine (TCM) treatment in two sessions, each lasting 10
days. During the first session, participants will receive daily 30-minute
acupuncture sessions. After a 10-day break, the second session of TCM treatment
will commence.
·
Additionally,
participants in Group 1 will engage in Palming throughout the study period.
Palming sessions will be conducted daily for one month, procedure every 3 hours
for 5 minutes with 6 rounds, upon waking up till before bedtime, consistently
for the duration of the 30-day study period.
·
Group 2, will solely
participate in Palming. Palming sessions will be repeated this prescribed
Palming procedure every 3 hours for 5 minutes with 6 rounds, upon waking up
till before bedtime, consistently for the duration of the 30-day study period.
Group
3, the control group, will not receive any intervention but they will be
fulfilling the inclusion and exclusion criteria. |