| CTRI Number |
CTRI/2021/01/030335 [Registered on: 08/01/2021] Trial Registered Prospectively |
| Last Modified On: |
07/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Scientific trial to study the effect of two Adjuvant sugar and honey with haritaki(Terminalia Chebula) in patients with Simple Myopia |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Evaluate the Efficacy of Pathya Prayoga with Different Anupanas in the Management of Prathampatalgat Timir 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 Manjiri Keskar |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD-108,Parul Ayurveda hospital, Shalakyatanthra department, Parul University,At p.o-limda,Tal-Waghodia, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9822606358 |
| Fax |
|
| Email |
manjirikeskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anu Vijayan |
| Designation |
Pg Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD-108,Parul Ayurveda hospital, Shalakyatanthra department, Parul University,At p.o-limda,Tal-Waghodia, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9495081420 |
| Fax |
|
| Email |
anuvijayan88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anu Vijayan |
| Designation |
Pg Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD-108,Parul Ayurveda hospital, Shalakyatanthra department, Parul University,At p.o-limda,Tal-Waghodia, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9495081420 |
| Fax |
|
| Email |
anuvijayan88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital
Parul University, P.O.Limda, Tal.Waghodia, vadodara, Gujarat, Pin:391760 |
|
|
Primary Sponsor
|
| Name |
Dean Parul institute of Ayurved |
| Address |
Parul institute of Ayurved,
Parul University, P.o.Limda, tal. Waghodia, Vadodara, Gujarat. Pin:391760 |
| 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 Anu Vijayan |
Parul Ayurveda Hospital |
OPD-108,Parul Ayurveda hospital, Shalakyatanthra department, Parul University,At p.o-limda,Tal-Waghodia, Vadodara, Gujarat
Vadodara
GUJARAT |
9495081420
anuvijayan88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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 |
| Intervention |
Pathya Prayoga with Madhu in Prathamapatalagata Timira ( Simple Myopia) |
Group A:pathya 6 gm + Madhu 12ml B.D. before Food for 30 days |
| Comparator Agent |
Pathya Prayoga with Sita in prathamapatalagata Timira (Simple Myopia) |
Group B: Pathya 6gm + Sita 6gm B.D, Before Food for 30 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
The patients presenting with features of Prathamapatalagata Timira (Simple Myopia) will be selected irrespective of gender, occupation, religion etc.
Patients having -0.25Ds to -3Ds of vision.
|
|
| ExclusionCriteria |
| Details |
Congenital Myopia
Myopia with known cases of Hypertension, Diabetes Mellitus, Tuberculosis etc.
Patients more than -3Ds of vision.
Patient with retinal diseases
Patient underwent any of the ophthalmic surgeries.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptoms like Blurring of Vision, Eye Strain, Headache, Watering of Eyes |
15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from Blurring of Vision, Eye Strain, Headache, Watering of Eyes |
60 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
11/01/2021 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Being one of the prime sensory organs, the protection of eyes is given
much importance in all phase of science. Timira or Myopiais the most
common eye disease prevailing on a large scale (Prevalence of myopia in India is found to be 6.9%) , And is adversely affect the overall quality of life
of the individuals. Currently,
there are no treatments that can permanently reverse myopia. It
can be corrected by prescribing eyeglasses, contact lenses, LASIK and
other laser eye surgeries.
For its management, classical therapies mentioned in our ancient
literature need to be re-established.Anupana (Adjuvent)is the unique and unexplored area in Ayurveda. Anupana (Adjuvent) is
defined as that, which enhances the properties of medicines along with it is
taken. With different Anupana (Adjuvent) a single oushadha dravya can
give different effects. By giving Anupana with Oushadhas we can
get more effect in a short time. Hence the study intended to compare the action of
different Anupanas with Pathya Prayoga in the management of Prathamapatalagata
Timira with special reference to Simple Myopia. |