| CTRI Number |
CTRI/2017/08/009353 [Registered on: 11/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of eye oleation and stimulation of vital energy points in Myopia. |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Effect of Tarpana karma And Marma Therapy in Management Of Prathama Patalagata Timira w.s.r To 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 Gunjan Sharma |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
Shlakaya Department, Opd no-5
Rishikul Campus, Uttarakhand Ayurved University, Haridwar
Shlakaya Department, Opd no-5, Rishikul Campus, Uttarakhand Ayurved University, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9258030654 |
| Fax |
|
| Email |
gunjan06sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lotika Bharti |
| Designation |
MD Scholar |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
Shlakaya Department, Rishikul Campus, Uttarakhand Ayurved University, Haridwar
Shlakaya Department,Rishikul Campus, Uttarakhand Ayurved University, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9596771236 |
| Fax |
|
| Email |
lotikabharti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lotika Bharti |
| Designation |
MD Scholar |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
Shlakaya Department, Rishikul Campus, Uttarakhand Ayurved University, Haridwar
Shlakaya Department, Rishikul Campus, Uttarakhand Ayurved University, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9596771236 |
| Fax |
|
| Email |
lotikabharti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus UAU |
| Address |
Department of Shlakaya, Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Lotika Bharti |
Rishikul campus, haridwar |
Shlakaya Department,Room no-5
Rishikul Campus
Uttarakhand Ayurved University, Haridwar
Hardwar
UTTARANCHAL |
9596771236
lotikabharti@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 |
patient having discomfort in distant vision, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A-Tarpana with Phalatrikadi Ghrita
Group B-20 times twice a day |
Group A-2 times 7 days off 7 days on (28 days)
Group B-Locally on respective marma points(28 Days) |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. The patients presenting with classical features of Prathama Patalagata Timira/simple myopia after proper screening.
2. Patients having -0.25D to -1.5D of vision
3. Snellen’s chart reading for distant vision should be equal or less than 6/24
|
|
| ExclusionCriteria |
| Details |
1. Dwitiya ,Tritiya and Chaturtha Patalagata Timira
2. High Myopia or progressive Myopia, Congenital Myopia
3. Patients more than -1.5D of vision.
4. Refractive errors like Hypermetropia, Astigmatism and other ocular pathologies
5. Myopia with systemic diseases like T.B, Hypertension, Diabetes Mellitus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameter:
Cured : more than 90 % relief in signs and symptoms and no recurrence during follow up study
Marked improvement: 75% to 90 % improvement in signs and symptoms
Moderate improvement: 50% to 75% improvement in signs and symptoms.
Mild improvement: 25% improvement in signs and symptoms.
Unchanged: less than 25% reduction in signs and symptoms.
|
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exacerbation of Signs and symptoms |
1 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/12/2016 |
| 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="7"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Timira is one of the Drishtigata Rogas which
is said to be a Paramdarun vyadhi, because it is a progressive
disease which invades Patalas in progressive nature and ultimately ends in
blindness. On the basis of clinical feature of Timira described in texts
Prathama Patalagata Timira can be correlated with myopia. Myopia
is a common refractive error in which one can see near objects clearly, but
objects farther away are blurred. Prevalence of myopia is increasing now a day.
In India its prevalence in general population is reported to be 6.9%. Treatment
modalities include eyeglasses, contact lenses and refractive surgery. But there
are certain precincts that give way to Ayurveda to treat this common
problem. With this aim “A Comparative Clinical Study to Evaluate
the Effect of Tarpana Karma and Marma Therapy in Management of Prathama Patalagata Timira w.s.r. To
Myopia†was undertaken on 40 clinically diagnosed patients of Prathama Patalagata Timira/ myopia were
randomly selected from O.P.D / I.P.D. of P.G Department of Shalakya Tantra, Rishikul Campus, Haridwar. The clinical study was done dividing the total cases into two groups of 20
each. In Group A- Tarpana Karma with Phalatrikadi Ghrita
for 28 days in 2 sittings of 7 days with 7 days gap. In Group B - Marma
Therapy was done on 6 Marma points (Apanga, Avarta, Sthapni, Vidhura,
Kshipra And Talahridya of feet) 20 times each point twice a day for 28 days. Results were assessed in relation to clinical signs and symptoms on the basis
of grading and scoring system and data were statistically analyzed
by adopting Wilcoxon’s Signed Rank Test
and Mann Whitney test U test for inter group comparison and results were
evaluated in terms of probability (p). Tarpana
Karma with Phalatrikadi Ghrita and
Marma Therapy both showed
statistically significant (p<0.05) results on subjective parameters
(blurring of vision, eye strain, headache and watering). Statistically significant
results were found in visual acuity and dioptric power in Group A which were
insignificant in Group B; whereas both the groups showed insignificant results
in axial length. None of the therapies showed any side effects. It can be
concluded from the study that Tarpana Karma with Phalatrikadi Ghrita is more efficient
in Prathama Patalagata Timira/ myopia. |