CTRI Number |
CTRI/2021/09/036900 [Registered on: 27/09/2021] Trial Registered Prospectively |
Last Modified On: |
22/09/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparative study of Moringa oleifera (SHIGRU) distillate EYE DROPS AND TRIPHALA (Terminalia chebula, Terminalia bellirika and Embilika officinalis) distillate EYE DROPS IN COMPUTER VISION SYNDROME |
Scientific Title of Study
|
A SINGLE BLIND RANDOMIZED COMPARATIVE CLINICAL STUDY ON EFFICACY OF SHIGRU ARKA ASCHYOTANA AND TRIPHALA ARKA ASCHYOTANA IN SHUSHKAKSHIPAKA (COMPUTER VISION SYNDROME) |
Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR JYOTHI S |
Designation |
ASSISTANT PROFESSOR |
Affiliation |
Government Ayurveda Medical College and Hospital Mysore |
Address |
DR. JYOTHI S. Assistant Professor, Dept. of Shalakya Tantra, Government Ayurveda Medical College and Hospital, New Sayyaji rao road, Vishweshwarayya Circle, Mysore- 570001. Karnataka Dept. of PhD Studies in Shalakya Tantra, Shri Dharmasthala Manjunatheshwara College of Ayurveda, B M Road, Tanniruhalla, Hassan, Karnataka Udupi KARNATAKA 570001 India |
Phone |
9449330827 |
Fax |
- |
Email |
drjyotiravindra@gmail.com |
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Details of Contact Person Scientific Query
|
Name |
DR ASHWINI M J |
Designation |
PROFESSOR and GUIDE |
Affiliation |
Raviva Gandhi University of Health Sciences Bangalore |
Address |
DR ASHWINI M J
PROF, HOD, PhD GUIDE
Dept. of PhD Studies in Shalakya Tantra, SDM College of Ayurveda, B M Road, Thanniruhalla, Hassan, Karnataka
DR ASHWINI M J
Physician Eye OPD
SDM Ayurveda Hospital, B M Road, Thanniruhalla, Hassan, Karnataka
Ph 7975489299 Hassan KARNATAKA 573201 India |
Phone |
94482222694 |
Fax |
- |
Email |
drashwinidhanpal@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR JYOTHI S |
Designation |
PhD Scholar (student) |
Affiliation |
Government Ayurveda Medical College and Hospital Mysore |
Address |
DR. JYOTHI S. Assistant Professor, Dept. of Shalakya Tantra, Government Ayurveda Medical College and Hospital, New Sayyaji rao road, Vishweshwarayya Circle, Mysore- 570001. Dept. of PhD Studies in Shalakya Tantra, Sri Dharmasthala Manunatheshwara College of Ayurveda, BM Road, Thanniruhalla, Hassan, Karnataka Mysore KARNATAKA 570001 India |
Phone |
9449330827 |
Fax |
- |
Email |
drjyotiravindra@gmail.com |
|
Source of Monetary or Material Support
|
No monetary support. Only Material support from:
PhD Department in Shalakya tantra Shri Dharmasthala manjunatheshwara College of Ayurveda and Hospital, Hassan-573201 Karnataka
And
Govt Ayurveda Medical COllege and Hospital, New Sayyaji Rao Road, Visweshwarayya Circle Mysore- 570001, Karnataka |
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Primary Sponsor
|
Name |
DR JYOTHI S self funded PhD research |
Address |
Dr Jyothi S Assistant Professor Shalakya Tantra Dept
Government Ayurveda Medical College and Hospital New Sayyaji rao road Vishweshwarayya Circle Mysore |
Type of Sponsor |
Other [Self Sponsored PhD Research under RGUHS Bangalore] |
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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 JYOTHI S |
SDM COLLEGE OF AYURVEDA and HOSPITAL HASSAN KARNATAKA |
Dept. of PhD Studies in Shalakya Tantra, POST BOX NO- 164, B.M. ROAD, THANNIRUHALLA, HASSAN- 573201 KARNATAKA Hassan KARNATAKA |
9449330827 - drjyotiravindra@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICAL COMMITTEE, SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: SHUKAKSHIPAAKA , |
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Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
SHIGRU ARKA EYE DROPS |
GROUP A
Shigru Arka eye drops instillation into both the eyes
2 drops in each eye, 6 times/ day (at 8am 10am 12pm 2pm 4pm and 6pm) with a gap of 2 hrs
Treatment duration 30 days follow up 60 days |
Intervention |
TRIPHALA ARKA EYE DROPS |
GROUP B
Triphala Arka eye drops instillation into both the eyes
2 drops in each eye, 6 times/ day (at 8am 10am 12pm 2pm 4pm and 6pm) with a gap of 2 hrs
Treatment duration 30 days follow up 60 days |
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Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Both |
Details |
Inclusion criteria:
a. Subjects between 20 to 40 years of age.
b. Computer and other mobile device users complaining of eye strain, dry eyes, headache, blurred vision, ocular pain, redness, glare sensitivity and progressive refractive changes – with 3 or more features.
c. Minimum 3 hour exposure to any type of VDT like desktop, laptop or both/day.
d. Minimum usage since 6 months.
|
|
ExclusionCriteria |
Details |
Exclusion criteria:
a. Subjects suffering from infectious conditions of the eye like conjunctivitis, scleritis, uveitis, glaucoma, stye, blepharitis etc.
b. Subjects having any fundus pathology like optic atrophy, diabetic retinopathy, hypertensive retinopathy, papilledema etc.
c. Subjects with neck and shoulder discomfort, back pain are excluded.
|
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Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Significant reduction in
Eye strain
Dry eyes
Blurred vision
Headache
Ocular pain
Redness
|
Trial duration - 30 days
Follow up - 60 days
Total- 90 days
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Schirmers I test
Tear film breakup time
|
Schirmers I test of 15mm wetting
Tear film breakup time of 10 sec
|
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Target Sample Size
|
Total Sample Size="220" Sample Size from India="220"
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
|
N/A |
Date of First Enrollment (India)
|
01/11/2021 |
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="5" 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)?
Response - NO
|
Brief Summary
|
Brief Resume of Intended Work: (A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHIGRU ARKA ASCHYOTANA AND TRIPHALA ARKA ASCHYOTANA IN SHUSHKAKSHIPAKA w.r.t COMPUTER VISION SYNDROME) Eyes are the main link between man and his environment. Eighty percent of what we perceive comes through our sense of sight.1 Computers and other mobile devices (tablets, e-readers, cell phones etc.) are an innovative and revolutionary inventions. Their multidimensional over usage compel us to spend more and more hours before their contrasts, flickering and glaring screens. This constantly strains the smooth eye muscles leading to Computer vision syndrome (CVS). According to American Optometric Association (AOA), “Computer vision syndrome, also referred to as Digital Eye Strain, describes a group of eye and vision related problems that result from prolonged computer, tablet, e-reader and cell phone useâ€.2 This newly found condition, frequently described in the lay press and World Wide Web has now been accepted in medical literature.3 Most studies indicate that computer operators who view their video display terminals (VDT) report more eye related problems than non VDT office workers. NIOSH Survey (National Institute of Occupational Safety and Health) has reported that visual symptoms occur in 75-90% of VDT workers as opposed to 22% of musculoskeletal disorders (carpel tunnel syndrome) in computer users.4 According to ‘National Institute of Occupational Safety and Health’, CVS affects people who spend 3 hours or more in front of computer per day.5 Personal mobile devices (i.e. smart phones) are so advanced that they are more like hand-held computers. Given the substantial number of hours being devoted to the viewing of electronic devices, it is concerning that the frequency of occurrence and magnitude of ophthalmologic symptoms is significantly higher. Ocular complaints such as eye strain, irritation and blurred vision experienced by electronic-device users as now known, universally as ‘Computer Vision Syndrome’.6 Computer vision syndrome has no direct reference in Ayurvedic classics. However, it can be largely correlated to the symptoms of Shushkakshipaka of Sarvakshiroga,7 as dryness is its main symptom. Nidana and Samprapti can be understood by trividha hetus (asatmya indriya artha samyoga, pragnaparadha and parinama) related to chakshurendriya (eye)8. Constant viewing at the computer screens for longer time with reduced blinking rate is one among the prominant causes of Dry eye syndrome9, which is a proven classical correlation of Shushkakshipaka. Hence Computer vision syndrome can be considered as an entity of Shushkakshipaka. Treatment of CVS in contemporary systems of medicine is purely symptomatic and lacks rejuvenation, improvement in eye sight and a permanent solution. Considering the alarming severity and high prevalence of ‘CVS’, there is an urgent need to come out with an effective and restorative treatment method. CVS and its symptoms are apparently because of the vitiated vata – pitta pradhana tridosha at chakshurendriya. Acharya Sushruta has advocated the use of Ghritapana, Tarpana, Nasya along with Parisheka. 10 Whereas, Acharya Vagbhata has mentioned about Anjana and Snigdha Dhumapana11 in the treatment of Shushkakshipaka. Considering the dosha involvement and based on the symptoms, Ayurvedic remedies can be used to effectively treat it. Therapies like ‘netra tarpana’, ‘netra dhara’, ‘aschyotana’, ‘ghrita pana’, ‘nasya’, ‘anjana’ and ‘triphala prayoga’12,13 are classically indicated. Whereas ‘shiro pichu’, ‘virechana’, ‘padabhyanga’, ‘asanas’, ‘pranayama’ and ‘chakshushya’ – ‘rasayana shamanoushadhis’ can be indicated based on symptoms and dosha predominance. ‘Shigru’ is counted as ‘chakshushya dravya’ by Acharya Sushrutha and Bhavaprakasha. It is a significant herbal drug indicated in almost all Netra rogas. ‘Shigru patra’ by virtue of its ‘madhura rasa’ and ‘sheeta guna’ (as per Kaiyyadeva Nighantu) is going to be beneficial here in the treatment of CVS. Furthermore, ‘Shigru’ is mentioned as ‘tridosha-shamaka’ (mitigates all three doshas); it also acts as ‘rasayana’ (rejuvenator); it is indicated in ‘shiroroga’; and it exhibits ‘Shothahara’ (antiinflammatory) and ‘Shulahara’ (analgesic) properies. All these specific inherent properties of the ‘Shigru’ will be indeed useful in the management of CVS. ‘Triphala’ (haritaki, vibhitaki and amalaki) is a well-known and commonly used formulation for both local and internal administration in many forms, for the treatment of ‘Netra roga’. It is also a known Rasayana (rejuvenator) and Chakshushya dravya15. Aschyotana has been explained as a ‘Prime Local Therapy’ in all the diseases of Eye especially in the conditions which present with ama-lakshanas like irritation, redness, burning sensation, etc16. Since the symptoms seen in CVS are similar to them, Aschyotana seem to counter the disease successfully as the application in the form of eye drops makes the drug available for immediate action and most convenient method of topical application, especially for daytime use. Arka is a unique preparation in which water soluble active principles and essential oils from the herbal drugs are extracted through drugs soaked in water using Arkayantra or any convenient modern distillation apparatus 17. Triphala Arka18 and Shigru Arka19 are the formulations explained in ‘Arka Prakasha’ and are indicated in Netra Roga. Therefore, the study has been taken up to compare the efficacies of Shigru Arka eye drops with Triphala Arka eye drops in the effective management of ‘Computer Vision Syndrome’. |