| CTRI Number |
CTRI/2024/07/071532 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Aurvedic Management of Asthenopia(Netraayas) |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Effect of Mahatriphala Ghrita With And Without Eye Exercises in The Management of Netraayas-Asthenopia |
| 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 Jaideep |
| Designation |
PG SCHOLAR |
| Affiliation |
Institute for Ayurved Studies And Research ,umri road sec 8,kurukshetra |
| Address |
R.NO.54,PG Department of Shalakya Tantra,Institute for Ayurved Studies And Research hospital ,umri road sec 8,kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9996661767 |
| Fax |
|
| Email |
jd.ranga786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashu |
| Designation |
Professor and Chairperson |
| Affiliation |
Institute for Ayurved Studies And Research ,umri road sec 8,kurukshetra |
| Address |
R.NO.108,PG Department of Shalakya Tantra,Institute for Ayurved Studies And Research hospital ,umri road sec 8,kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9416553131 |
| Fax |
|
| Email |
drashukataria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaideep |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies And Research ,umri road sec 8,kurukshetra |
| Address |
R.NO.54,PG Department of Shalakya Tantra,Institute for Ayurved Studies And Research hospital ,umri road sec 8,kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
09996661767 |
| Fax |
|
| Email |
jd.ranga786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies And Research ,umri road sec 8,kurukshetra 136118, Haryana, India |
|
|
Primary Sponsor
|
| Name |
Institute for ayurved studies and research |
| Address |
umri road sec 8 kurukshetra,136118 |
| 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 |
| Dr Jaideep |
Institute for Ayurved studies and research |
Room No. 54, Shalakya Tantra- Eye OPD
umri road sec 8 kurukshetra,136118
Kurukshetra
HARYANA |
09996661767
jd.ranga786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna AYUSH University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H527||Unspecified disorder of refraction. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | EYE EXERCISES | (Procedure Reference: Worrall RS, Neyvas J, Barrett S (6 July 2018). "Eye-Related Quackery". Quackwatch. Archived from the original on 22 May 2019. Retrieved 30 June 2019., Procedure details: MAHATRIPHALA GHRITA 10-20GM OD HS WITH EYE EXERCISES
PALMING,ZOOMIMG,FLEXING,MASSAGING,FIGURE8,BLINKING,
20-20-20 RULE,FOCUSING NEAR AND FAR,REST)
(1) Medicine Name: MAHATRIPHALA GHRITA , Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Ghrita, Dose: 20(g), Frequency: hs, Duration: 30 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: MAHATRIPHALA GHRITA, Reference: BHAISAJYA RATNAVALI, Route: Oral, Dosage Form: Ghrita, Dose: 20(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: USHNA JALA), Additional Information: MAHATTIPHALA GHRITA 10-20GM ONCE A DAY |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Refractive error ≤ 4 Diopter4.
2. Patients with sign and symptoms of Netraayas – Asthenopia will be
selected irrespective of Sex, Religion, Profession.
3. Patients those are fit for Ghritapaan according to ayurveda text.
4. Patients willing to be registered for trial. |
|
| ExclusionCriteria |
| Details |
1.Refractive error ≥4 Diopter.
2.Ghritpaan Ayogya.
3.Presbyopia
4.Chronic viral infections: e.g., Hepatitis C, HIV etc.
5.Neurological conditions: e.g., Parkinson disease, Bell’s palsy, Trigeminal neuralgia
6.Immunological diseases – Autoimmune disease, collagen vascular and immunodeficiency.
7.Pregnancy
8.Diabetes mellitus
9.Hyperlipidaemia
10.Hypertension. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement and management in Visual acuity measurement and
Extra ocular muscle functioning test
|
31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in sign and symptoms like Pain( In and around the Eye),Lacrimation, Vertigo , Headache, Photophobia of Netraayas - Asthenopia patients .
|
90th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/08/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The term Asthenopia means weakness or debility, of the eyes or vision, so the term may be best confined to describing symptoms arising from a visual or ocular anomaly,rather than purely extrinsic (e.g., environmental) factors.Asthenopia comprises the following symptoms such as weakness or early tiredness ofthe eye, ocular fatigue and discomfort, pain in and around the eyes, headache usually aggravated by the use of eyes for near work, lacrimation, itching, and dryness,sensitivity to light or difficulty in focusing, reflex symptoms as nausea, twitching of facial muscles, blurring of vision and intermittent diplopia may occur sometimes.Despite contradictory reports on the causes of Asthenopia, three significant groups of risk factors have been identified: visual disorders, such as refractive errors and accommodative dysfunctions; psychological factors such as daily stress and poor mental state; and environmental factors such as low ambient lighting, nonstandard monitor brightness; and long study periods. |