| CTRI Number |
CTRI/2020/09/027766 [Registered on: 11/09/2020] Trial Registered Prospectively |
| Last Modified On: |
10/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Eye Exercises and a special ayurvedic treatment Anjana (a form of kajal) in Near Sightedness |
|
Scientific Title of Study
|
EVALUATION OF EFFICACY OF EYE EXERCISES AND COMBINATION OF EYE EXERCISES AND GUDUCHYADI RASANJANA IN PRATHAMA PATALAGATA TIMIRA WITH SPECIAL REFERENCE TO SIMPLE MYOPIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sapna |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Shalakya tantra Department
Parul Institute of Ayurved
Parul University
Limda
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7988012524 |
| Fax |
|
| Email |
456sapna.sy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjiri Keskar |
| Designation |
Proffessor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Shalakya tantra Department
Parul Institute of Ayurved
Parul University
Limda
Vadodara
Shalakya tantra Department
Parul Institute of Ayurved
Parul University
Limda
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9822606358 |
| Fax |
|
| Email |
manjirikeskar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sapna |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Shalakya tantra Department
Parul Institute of Ayurved
Parul University
Limda
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7988012524 |
| Fax |
|
| Email |
456sapna.sy@gmail.com |
|
|
Source of Monetary or Material Support
|
| opd no. 108
Shalakya tantra Department
Parul Institute of Ayurved
Parul University
Limda
Vadodara |
|
|
Primary Sponsor
|
| Name |
Dean Parul Institute of Ayurved |
| Address |
Shalakya Tantra Department
Parul Institute of Ayurved
Parul University
Limda
Vadodara |
| Type of Sponsor |
Private 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 Sapna |
Parul Ayurved Hospital |
Opd No. -108
Shalakya Tantra Department
Parul Institute of Ayurved
Parul University
Limda
Vadodara
Vadodara
GUJARAT |
7988012524
456sapna.sy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
eye exercises |
Eye wash, Sunning, Palming, Shifting, Near and Far Focus, Clock rotation, Ball rotation, Blinking, Water splash, Cold Pack.
|
| Intervention |
Guduchyadi Rasanjana |
EVALUATION OF EFFICACY OF EYE EXERCISES AND COMBINATION OF EYE EXERCISES AND GUDUCHYADI RASANJANA IN PRATHAMA PATALAGATA TIMIRA WITH SPECIAL REFERENCE TO SIMPLE MYOPIA |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with classical features of Prathama Patalagata Timira.
Patients presenting with asthenopic symptoms
Age between 12-35 years.
With correction ≤ -3 DS
Those fit for Anjana
Those fit for Eye Exercises |
|
| ExclusionCriteria |
| Details |
Dwitiya, Trutiya and Chaturtha Patalagata Timira
With correction > -3 DS
Patients with ocular manifestations due to serious systemic illness.
Patient underwent any of the ophthalmic surgeries.
Those unfit for Anjana.
Those unfit for Eye Exercises |
|
|
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 |
| Improvement in vision, headache, eye strain, watering of eyes |
Day 0
Day 15
Day 45
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications like congestion in eyes, excessive watering of eyes, pain in eyes, itching, burning. |
Day 0
Day 15
Day 45 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/09/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•Timira
or
Myopia is
the most common eye disease prevailing on a large scale. It is associated with
blurred vision and asthenopic (eye
fatigue) symptoms which are; headache, eye strain and watering in eyes. These
adversely affect the overall quality of life of the individuals. For its
management, classical therapies mentioned in our ancient literature need to be
re-established today.
•Various
therapeutic measures are mentioned for the treatment of
timira
which
includes Tarpana,
Anjana, Nasya,
Snehpana,
Putapaka,
Shirobasti,
Virechan,
etc. •In Modern system of Medicine, spectacles
are used to correct the errors of refraction. But it neither cures the disease
nor prevents the progression. Surgeries and Laser are also prescribed but
sometimes, they come with complications. Also, they are not affordable to many
of our population.
•Hence, simple, non-invasive and
cost-effective treatment needs to be practiced for the management of
Timira.
Eye
exercises and Anjana
are such
widely
used procedures.
They not only
manage
Timira
but
also have
many
other benefits as well. There are no side effects and probable complications of
these
procedures.
•Guduchyadi
Rasanjana,
mentioned in Sharangdhara
Samhita, includes
Guduchi,
Saindhava
and
Madhu
as
its components, which are easily available and it has good ocular absorption
because it has very small molecular size due to its method of preparation and
its ingredients.
•
|