| CTRI Number |
CTRI/2024/07/071109 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Trataka Karma on Eye sight w.s.r. Myopia |
|
Scientific Title of Study
|
Evaluation of Trataka Karma on Improvement of vision w.s.r. to Mild Myopia |
| 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 Umesh Shukla |
| Designation |
HOD of Swasthavritta department |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
Room no 411 Swasthavritta department anatomy block rggpg
ayurvedic college and hospital paprola district kangra
Himachal Pradesh
176115
India
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018242861 |
| Fax |
|
| Email |
dr.umeshshukla1969@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Shukla |
| Designation |
HOD of Swasthavritta department |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
Room no 411 Swasthavritta department anatomy block rggpg
ayurvedic college and hospital paprola district kangra
Himachal Pradesh
176115
India
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018242861 |
| Fax |
|
| Email |
dr.umeshshukla1969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh Shukla |
| Designation |
HOD of Swasthavritta department |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
Room no 411 Swasthavritta department anatomy block rggpg
ayurvedic college and hospital paprola district kangra
Himachal Pradesh
176115
India
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018242861 |
| Fax |
|
| Email |
dr.umeshshukla1969@gmail.com |
|
|
Source of Monetary or Material Support
|
| RGGPG Ayurvedic College and Hospital Paprola distt.Kangra(H.P.)PIN.176115 |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College and hospital Paprola |
| Address |
Department of swasthavritta rggpg ayurvedic college and hospital Paprola Distt Kangra(H.P.)176115
paprola |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Umesh Shukla |
Room no 411 top floor Anatomy Block RGGPG
Ayurvedic College and Hospital Paprola |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ekta Sharma |
RGGPG Ayurvedic College and hospital paprola |
RGGPG Ayurvedic College and hospital paprola Pin.176115 Anatomy block top floor Swasthavritta Dept room no.411
Kangra
HIMACHAL PRADESH |
7657856728
drektash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human RGGPG Ayurvedic College and Hospital Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: DRUSHTIGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Sodhana-karma, षोधन-करà¥à¤® | (Procedure Reference: Hath yoga pradeepika, Procedure details: Trataka will be done for 2 months continuously once a day at dawn and dusk)
|
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
i.Volunteers willing for the trial.
ii.Male and female participants of age between
12-30 years.
iii.Patients with classical symptoms of mild
myopia upto -1.0 D.
|
|
| ExclusionCriteria |
| Details |
i.Volunteers unwilling to participate in the trial.
ii.Volunteers below 12 years and above 30 years.
iii.Patients having myopia more than -1.0 D
iv.Known cases of Diabetes mellitus, Hypertension
any Cardiovascular disorders.
v.Volunteers undergoing treatment for any
medical condition.
vi.Other eye diseases where Trataka is not
feasible.
vii.Pregnant and lactating mother.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vision Improvement |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Eradicates eye diseases,fatigue and reduces strain in the eyes and headache. |
1st follow up will be done on 30th day and 2nd followup will be done on 60th day of the trial(on the completion of the trial).
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2024 |
| 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
|
Effect of Trataka Karma on improvement of vision will be accessed. Purpose of the trail is to improve vision, reduction in eyes strain and headache. The procedure of Trataka Karma will be performed daily once a day for 2 months. |