CTRI Number |
CTRI/2020/06/026025 [Registered on: 22/06/2020] Trial Registered Prospectively |
Last Modified On: |
12/05/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical study for Ayurvedic management of Simple Myopia. |
Scientific Title of Study
|
A randomized open label comparative clinical study to evaluate the efficacy of shigru pallava arka nasya and eye exercise in prathamapatalagata 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 Sandeep S |
Designation |
PG scholar |
Affiliation |
Sri Sri College of Ayurvedic Science and Research |
Address |
Room no 306, Department of PG studies in Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura Road, Udayapura Road, Bangalore-82.
Bangalore KARNATAKA 560082 India |
Phone |
6282241564 |
Fax |
|
Email |
sandeepkottapuram@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sandhya Ganesh K |
Designation |
Professor |
Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
Address |
Room no 306, Department of PG studies in Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura Road, Udayapura Road, Bangalore-82.
Bangalore KARNATAKA 560082 India |
Phone |
9449349263 |
Fax |
|
Email |
drsandyaganeshk@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sandeep S |
Designation |
PG Scholar |
Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
Address |
Room no 306, Department of PG studies in Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura Road, Udayapura Road, Bangalore-82.
Bangalore KARNATAKA 560082 India |
Phone |
6282241564 |
Fax |
|
Email |
sandeepkottapuram@gmail.com |
|
Source of Monetary or Material Support
|
Sri Sri College of Ayurvedic Science and Research Hospital, 21st km, Kanakapura road, udayapura post, Bangalore-98 |
|
Primary Sponsor
|
Name |
Dr Sandeep S |
Address |
Room no 306, Department of PG studies in Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura Road, Udayapura post, Bangalore-82. |
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 Sandeep S |
Sri Sri College of Ayurvedic Science and Research Hospital |
Room no 06,OPD - Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura Road, Udayapura post, Bangalore-82. Bangalore KARNATAKA |
6282241564
sandeepkottapuram@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SRI SRI 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 |
Comparator Agent |
Eye Exercise |
8 exercises
Time- morning
Duration- 30 days
Frequency - Once a day
1. Sunning
2. Eye wash
3. Palming
4. Candle Flame Concentration
5. Shifting and Swinging
6. Ball Exercise
7. Vaporization
8. Eye Pad
|
Intervention |
Nasya with Shigru Pallava Arka |
Dose- 8 bindus in each nostril
frequency - Once a day for 7 days
Time- morning- empty stomach
Duration-7 days
Route of administration - Nasal
|
|
Inclusion Criteria
|
Age From |
8.00 Year(s) |
Age To |
18.00 Year(s) |
Gender |
Both |
Details |
1. Subjects irrespective of their gender, caste and religion will be included
2. Subjects presenting with clinically established condition of Simple Myopia.
3. Optical correction ranging from -0.5D to -5Dsph
|
|
ExclusionCriteria |
Details |
1. Pathological Myopia and High Myopia with degenerative changes, retinal changes and structural deformities like cataract and corneal opacity.
2. Subjects suffering from any of the systemic disorders (Hypertension,Diabetes, Tuberculosis, Syphilis), endocrinal or nutritional disorders.
3. Subjects who have underwent any of the refractive surgeries.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Improvement in Snellens Visual Acuity and Auto-Refractive meter Reading |
Baseline, 8th day, 31st day, 60th day of study period |
|
Secondary Outcome
|
Outcome |
TimePoints |
Subjective Improvement in asthenopic symptoms related myopia. |
8th day, 31st day, 60th day. |
|
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 3 |
Date of First Enrollment (India)
|
01/08/2020 |
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
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Simple Myopia
is the most common clinical variety of Myopia (distant vision impairment) seen
in children and in adults. Its symptoms include diminution of vision for
distance in varying degrees depending on the amount of refractive error and
Asthenopic symptoms such as eye strain, headache etc.
This symptom is mentioned as Avyaktha Darshana in Prathama
Patalagata Timira, a stage of Timira described under Drushtigata Rogas.
The available treatments of refractive errors include
using of power glasses and surgical treatment.
Soldiers, sailors, athletes, workmen and children have
great difficulty with glasses because of the activity of their lives, which not
only leads to breaking of the lenses but often throws them out of focus. At
their best it cannot be maintained that glasses are anything more than a very
unsatisfactory substitute for normal vision.
Surgical
intervention although popular is not affordable to everyone and may be
associated with complications such as dry eye and night glare which can be
annoying.
Thereby, due to these downsides, there is an immediate
requirement of wholesome treatment measures which can manage this visual
infirmity and ensure the disease does not progress. Acharyas of Ayurveda consider
Indriyas (sense organs) as one of the
vital components of Ayu(life), and
have described various well designed treatment modalities comprising of Chakshushya dravyas, Netra kriyakalpas, relevant changes in Ahara and vihara, and other remedial strategies, which are said to escalate
visual acuity, strengthen the indriyas
and also avert consequent ocular complications.
Shigru is a Chakshushya
dravya indicated in many Netra vikaras. The Arka preparation of the same can be not only very potent but also a
sterile form of medicine in the treatment of eye disorders. In this study an effort is made to evaluate the
efficacy of Shigru Pallava Arka Nasya and Eye Exercise in
the management of Prathama Patalagata
Timira (Simple Myopia.) |