| CTRI Number |
CTRI/2024/05/067637 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| 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
|
Comparing Traditional Chinese Medicine Acupuncture and Trataka Yoga Techniques for Managing Myopia in Adult Women |
|
Scientific Title of Study
|
Investigating the Efficacy of TCM based Acupuncture and Trataka (yogic practice) for myopia management in 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 Katakam Bhavana |
| Designation |
PG Student |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Room no 8
2nd floor
Research Department
Manu Makhija Bhawan
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women
Bairagarh
Bhopal
Madhya Pradesh
India
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7337030996 |
| Fax |
|
| Email |
bhavanakatakam1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavit Bansal |
| Designation |
Assistant Professor |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Room number 08
2nd floor
Manu Makhija Block
Sant Hirdaram Medical of Naturopathy and Yogic Sciences for Women
Bairagarh
Bhopal
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 |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Room number 08
2nd floor
Manu Makhija Block
Sant Hirdaram Medical of Naturopathy and Yogic Sciences for Women
Bairagarh
Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7597733931 |
| Fax |
|
| Email |
shmcnys.bhavit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 8
2nd floor
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Bhopal Madhya Pradesh India |
|
|
Primary Sponsor
|
| Name |
Dr Katakam Bhavana |
| Address |
Room number 54
4th floor
Block A
Sant Hirdaram Girls Hostel
Bairagarh
Bhopal
Madhya Pradesh
India |
| 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 Bhavana Katakam |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
Room no 8 2nd floor Research Department Manu Makhija Bhawan Behata Bairagarh Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH |
7337030996
bhavanakatakam1@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 Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H475||Disorders of other visual pathways, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TCM based Acupuncture |
Intervention will be for 30 minutes on alternate days for 2 months
The points are UB 1 UB2 ST1 GB20 GB37 LIV3 LI4 of manual stimulation is given of scalp stainless needles will be used and will be given by BNYS qualified doctor |
| Comparator Agent |
Trataka yogic practice |
Intervention of whole session will be for 30 minutes on alternate days for 2 months which is divided into 3 phases of which the preparatory eye exercises of 10min followed by Jyoti trataka in which two stages that is efforting gazing and intensive gazing will be for 10 minutes and final phase is defocusing and silence will be 10 minutes instructed by BNYS qualified doctor |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Female adults aged between 18 to 45 years
Participants must have been diagnosed with myopia or nearsightedness by a qualified ophthalmologist or optometrist
Participants with mild to moderate myopia up to -6.00 diopters will be included
Participants with no history of previous eye surgery for myopia correction
Participants with stable refractive error over the past six months with no significant changes in prescription
Participants capable of understanding the trial procedures and providing informed consent prior to participation
|
|
| ExclusionCriteria |
| Details |
Individuals without a confirmed diagnosis of myopia
Participants with severe myopia greater than -6.00 diopters or pathological myopia
Individuals incapable of understanding the trial procedures or providing informed consent
Participants with systemic diseases example diabetes autoimmune disorders that may affect ocular health or study outcomes
Participants with a history of previous eye surgery for myopia correction
Individuals with a history of significant changes in refractive error within the past six months
Participants with severe eye conditions example glaucoma, retinal detachment other than myopia that may confound the study results |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Focal length of the refractive error |
Snellen eye chart test and Refractive eye test and National Eye Institute Visual Function Questionnaire will be taken on 0th day and 60th day of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual acuity and ocular health and ocular quality of life |
Snellen eye chart test and Refractive eye test and National Eye Institute Visual Function Questionnaire will be taken on 0th day and 60th day of 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)
|
20/06/2024 |
| 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="0"
Months="2"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
The Randomised Controlled study aims to Investigate the Efficacy of Traditional Chinese Medicine based Acupuncture and Trataka yogic practice for myopia management in female adults The primary objective is to assess the comparison effectiveness of TCM-based acupuncture and Trataka in
reducing the progression of myopia in female adults The secondary objective is to assess the safety and tolerability of both TCM based Acupuncture and
Trataka as therapeutic modalities in female adults The study will be for 2 months with the sample size of 60 participants The intervention involves session of TCM based Acupuncture for 30 minutes on alternate days for 2 months and points are UB1 UB2 ST1 GB20 GB37 LIV3 LI4 with the usage of stainless scalp needles The comparator agent will be Trataka a yogic practice of whole session is for 30 minutes on alternate days for 2 months The asseesment will be done by Snellen chart test and Refractive eye test and National Eye Institute Visual Function Questionnaire for both the groups The participant withdrawal is allowed at anytime and safety and adverse events will be monitered and reported to the institutional ethical committee |