| CTRI Number |
CTRI/2024/06/069361 [Registered on: 21/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare The Action Of Triphala Madhu Sarpi In Computer Vision Syndrome Administered During Different Times Of The Day. |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Study of Triphala Madhu Sarpi Administered During Nishi Kala and Adhobhakata Aushadha Sevana Kala in Computer Vision Syndrome. |
| 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 Kailash |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda, Deemed to be University |
| Address |
Department of Dravyaguna, National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh gate, Amer Road
Jaipur
RAJASTHAN
302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9610077396 |
| Fax |
|
| Email |
KAILASHPATEL529@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudipt Kumar Rath |
| Designation |
M.D., Ph.D.(Ayu) Associate Professor |
| Affiliation |
National Institute of Ayurveda, Deemed to be University |
| Address |
Department of Dravyaguna, National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh gate, Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9828376668 |
| Fax |
|
| Email |
sudipt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudipt Kumar Rath |
| Designation |
M.D., Ph.D.(Ayu) Associate Professor |
| Affiliation |
National Institute of Ayurveda, Deemed to be University |
| Address |
Department of Dravyaguna, National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh gate, Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9828376668 |
| Fax |
|
| Email |
sudipt@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Deemed to be University, Joraver Singh Gate, Amer Road, Jaipur, Rajasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda, Deemed to be University |
| Address |
Joraver Singh Gate, Amer Road, Jaipur, Rajasthan 302002 |
| 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 Kailash |
National Institute of Ayurveda, Deemed to Be University |
OPD No. 14 National Institute of Ayurveda Hospital, Deemed to Be University, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan 302002.
Jaipur
RAJASTHAN |
9610077396
kailashpatel529@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of National institute of Ayurveda, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H531||Subjective visual disturbances. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala Madhu Sarpi, Reference: Asthang Hridayam sutrasthan 9, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 15(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -In Classical Text, Nishi Kala Is Mentioned for Administration of Triphala Madhu Sarpi. But Nishi Kala Is Not Mentioned in Option Available in CTRI That Why I Mention Adhobhakta Kala Equivalent to Nishi Kala. Adhobhakta Bhaishajya Kala mention in Charak Samhita chikitsa sthan 30 As two times in day 1. After morning food. 2. After Evening food. That why I mention this. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala Madhu Sarpi, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 15(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: For comparision which time of drug administration best. |
|
|
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Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of irrespective gender & socio-economic status who spend more than 3 hours/ day in front of screen (Computer, T.V., Mobile screen).
2. Patients showing any ocular and extra ocular sign and symptoms of Computer Vision Syndrome (Red eyes, burning eyes, itching, eye strain, headache, neck/ shoulder pain/ backpain. |
|
| ExclusionCriteria |
| Details |
1. Age below 10 Years and Above 40 Years.
2. Patients with clinically significant systematic disease e.g. Hypertension, Diabetes mellitus
Migraine.
3. Pre-existing dry eyes or using lubricants or tear drop.
4. Patients who undergone eye surgery.
5. Patients on topical medication for long time. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the Computer Vision Syndrome– Questionnaire (CVS-Q) administered during Nishi kala and Adhobhakata aushadha sevana kala. |
3 months duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in the Computer Vision Syndrome– Questionnaire (CVS-Q) administered during Nishi kala and Adhobhakata aushadha sevana kala. |
Patient will be assessed at baseline (0), and 3rd Months. |
|
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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 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Computer vision syndrome (CVS) is such a disease, and associated mainly with improper and long-standing use of computer. It is also describing the inclusion of ocular, visual and musculoskeletal symptoms due to prolonged use of computer. Being a disease of modern era, it is difficult to get the nearest resembling disease in Ayurveda excellence. There is no evidence that it causes any casualty but eye being prime organ of visual execution becomes highly exhausted there by it decreases the “standard of living†or “Quality of life†by reducing the work efficiency. As Acharya Vagbhat said that use of Triphala Madhu sarpi in Nishi Aushadha sevana kala give nourishment to Netra (Ocular apparatus). Aushadha Sevan Kala is the type of Avasthik Kala meant for the proper time of drug administration. So, there is importance aushadha sevana kala for administration of medicine is important for work up to their maximum efficacy. Drugs administration in Nishi kala for the diseases above the clavicle (Urdhavjatru gata Vikaar) helps medicine to work on that region. Present study was planned with an aim and objectives, to compile and commemorate the references of computer vision syndrome and its related diseases in Ayurveda excellence, postulate the Samprapti Ghataka (Patho -physiology) of computer vision syndrome according to Ayurveda, hypothetically and rule out the effect of Triphala Madhu Sarpi in Nishi kala And Adhobhkata Aushadha sevana kala for reliving the sign and symptoms of computer vision syndrome. AIM To explore and compare the efficacy of Triphala Madhu Sarpi administered during Nishi kala And Adhobhakta Aushadha Sevana Kala In Computer Vision Syndrome. OBJECTIVES 1. To study the efficacy of Triphala Madhu Sarpi administered during Nishi Aushadha Sevana kala Computer Vision Syndrome. 2. To study the efficacy of Triphala Madhu Sarpi administered during Adhobhakta Aushadha Sevana kala Computer Vision Syndrome. 3.To compare the efficacy of Triphala Madhu Sarpi administered during Nishi kala And Adhobhakta Aushadha Sevana Kala In Computer Vision Syndrome. Null Hypothesis(H0): There is no difference between efficacy of Triphala Madhu Sarpi administered during Nishi kala and Adhobhakta Aushadha Sevana Kala in Computer Vision Syndrome. Alternate Hypothesis(H1): There is difference between efficacy of Triphala Madhu Sarpi administered during Nishi kala and Adhobhakta Aushadha Sevana Kala in Computer Vision Syndrome. Study design: Phase of Clinical study : Phase II/III ; Study Type : Interventional, Parallel Arm, Single Center, Open Label; Timing : Prospective; Number of Groups : Two ; Number of Patients : 60 ; Duration of Study : 90days.
The statistical analysis of the research will be done using the appropriate statistical tests and with a significance level of <0.05 and 80 % statistical power. |