| CTRI Number |
CTRI/2017/08/009518 [Registered on: 28/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
26/08/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of some herbal formulations in the management of Computer Vision Syndrome |
|
Scientific Title of Study
|
Clinical Evaluation of Efficacy of Mahatriphaladi Ghritam and Anu Taila Nasyam in the Management of Computer Vision Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mridula dua |
| Designation |
Research Officer (AY) Scientist-4 |
| Affiliation |
Ayurveda Central Research Institute |
| Address |
Ayurveda Central Research Institute
Road No. 66
Punjabi bagh West
New Delhi
Road No. 66
Punjabi bagh West
New Delhi 110026
West
DELHI
110026
India |
| Phone |
01125221059 |
| Fax |
01125225546 |
| Email |
drmriduladua@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakhi Mehra |
| Designation |
Assistant Director (AY) |
| Affiliation |
Ayurveda Central Research Institute |
| Address |
Ayurveda Central Research Institute,
Road No. 66,
Punjabi bagh West,
New Delhi
Road No. 66,
Punjabi bagh West,
New Delhi
West
DELHI
110026
India |
| Phone |
01125229448 |
| Fax |
01125225546 |
| Email |
acri.delhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakhi Mehra |
| Designation |
Assistant Director (AY) |
| Affiliation |
Ayurveda Central Research Institute |
| Address |
Ayurveda Central Research Institute,
Road No. 66,
Punjabi bagh West,
New Delhi
Road No. 66,
Punjabi bagh West,
New Delhi
West
DELHI
110026
India |
| Phone |
01125229448 |
| Fax |
01125225546 |
| Email |
acri.delhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences,JLNBCEHAB,No.61-65,Institutional area,opposite Dblock,Janakpuri,New Delhi |
|
|
Primary Sponsor
|
| Name |
Centrral Council for Research in Ayurvedic Sciences |
| Address |
JLNBCEHAB, No.61-65, Institutional area, Opp. D Block, Janakpuri, New Delhi |
| 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 Mridula Dua |
Ayurveda Central Research Institute |
Ayurveda Central Research Institute, Road No. 66, Punjabi Bagh West, New Delhi
West
DELHI |
9654102542
01125225546
drmriduladua@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Computer Vision Syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anu Tailam, Mahatriphaladi Ghritam |
Anu Tailam -8 nasal drops in the morning for 7 days, Tarpana with Mahatriphaladi Ghritam for 3 days at an interval of 15 days (i.e. 8th,9th,10th day and 26th,27th 28th day), Mahatriphaladi Ghritam 5 ml twice a day orally for 42 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
i) Patients of either sex aged between 18 to 35 years
ii) Patients having minimum three symptoms of Computer Vision Syndrome (Eye strain and fatigue,Headache, blurred vision, Dry and irritated eyes, Neck and shoulder pain, Double vision,Redness of eyes, Burning eyes, excessive tearing and photophobia)
iii) Minimum 3 hours daily exposure to any type of Video Display Terminals like Desktop, Laptop or both
iv) Minimum 1 year exposure to any type of above mentioned VDTs
v) Willing patients with informed consent obtained.
|
|
| ExclusionCriteria |
| Details |
i) Age less than 18 years and more than 35 years
ii) Presence of signs and symptoms due to direct physiological effects of substance (medication, drug abuse) or presence of any general health problems (like Hypothyroidism)
iii) Presence of any infectious conditions of the eye, Cataract, Glaucoma, stye, any fundus pathology.
iv) Patients having Cervical spondylosis or spasm of trapezius muscle.
v) History of any surgical intervention with reference to the eye
vi) Patient with h/o Migraine
vii) Patients with h/o Hypertension or Diabetes Mellitus
viii) Patients with evidence of malignancy.
ix) Patients on prolonged ( 6 weeks) medication withcorticosteroids, antidepressants, anticholinergics, oral Contraceptive pills, etc.or any other drugs that may have an influence on the outcome of the study.
x) Patients with major systemic illness
xi) Patients with concurrent serious hepatic disorder defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine1.2mg/dL), Known case of Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]),
or any other condition that may jeopardize the study.
xii) Smokers/ Alcoholics and/or drug abuser
xiii) H/o hypersensitivity to any of the trial drug or their ingredients
xiv) Pregnant / lactating woman.
xv) Patients who have completed participation in any other
clinical trial during the past six (06) months
xvi) Any other condition which the Principal Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of CVS |
Reduction in signs and symptoms of Computer Vision Syndrome at baseline and at the end of42nd Day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/04/2015 |
| Date of Study Completion (India) |
05/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Paper will be published after completion of the project |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is open level, not controlled, single group study for evaluating efficacy of Mahatriphaladi ghritam orally 5 ml twice a day for 42 days, 8-8 Nasal drops of anu Tailam for 7 days, Tarpana (Local eye treatment) with Mahatriphadi Ghritam for 3 days at the interval of 15 days. The trial will be conducted at ACRI Punjabi Bagh, New Delhi. The primary outcome measures will be reduction in sigs and symptoms of Computer Vision Syndrome. |