| CTRI Number |
CTRI/2025/08/093845 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Role of Saindhavadya Anjana and Carboxy Methyl Cellulose eye drop with Jeevaniya Taila Nasya for treating Shushkakshipaka with special reference to Computer Vision Syndrome |
|
Scientific Title of Study
|
A randomized comparative clinical trial on the efficacy of Saindhavadya Anjana and Carboxy Methyl Cellulose eye drop each combined with Jeevaniya Taila Nasya in the management of Shushkakshipaka with special reference to Computer Vision Syndrome |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahima Choudhary |
| Designation |
Ph.D. Scholar |
| Affiliation |
National Institute of Ayurveda Deemed to be University (De-novo) Jaipur |
| Address |
PG Department of Shalakya Tantra National Institute of Ayurveda Deemed to be University (De-novo) Jorawar Singh Gate, Amer Road, Jaipur (Raj.)
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461267615 |
| Fax |
|
| Email |
mahimachoudhary7615@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Gulab Chand Pamnani |
| Designation |
M.S. (Ayu), Ph.D. Professor |
| Affiliation |
National Institute of Ayurveda Deemed to be University (De-novo) Jaipur |
| Address |
PG Department of Shalakya Tantra National Institute of Ayurveda Deemed to be University (De-novo) Jorawar Singh Gate, Amer Road, Jaipur (Raj.)
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461154942 |
| Fax |
|
| Email |
pamnani.gulab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahima Choudhary |
| Designation |
Ph.D. Scholar |
| Affiliation |
National Institute of Ayurveda Deemed to be University (De-novo) Jaipur |
| Address |
PG Department of Shalakya Tantra National Institute of Ayurveda Deemed to be University (De-novo) Jorawar Singh Gate, Amer Road, Jaipur (Raj.)
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461267615 |
| Fax |
|
| Email |
mahimachoudhary7615@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Deemed to be University (De-novo) Jaipur (Raj.) |
|
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Primary Sponsor
|
| Name |
National Institute of Ayurveda Deemed to be University (De-novo) Jaipur (Raj.) |
| Address |
National Institute of Ayurveda Deemed to be University (De-novo) Jorawar Singh Gate, Amer Road, Jaipur (Raj.) |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahima Choudhary |
National Institute of Ayurveda Deemed to be University (De-novo) Jaipur |
OPD NO. 14, PG Department Of Shalakya Tantra, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
09461267615
mahimachoudhary7615@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda Deemed to be University (De-novo) Jaipur |
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:H539||Unspecified visual disturbance. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Carboxy Methyl Cellulose Eye drop | Dose: 1 drop in each eye
Mode of Administration: Topically in form of Eye drop
Duration: Four times a day for 28 days
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shunthyadi Ghan Vati, Reference: Prof. Siddhi Nandan Mishra. Bhaisajya Ratnavali of Kaviraj Govind Das Sen, reprint edition 2021, Varanasi; Chaukhambha Surbharati Prakashan, 8/6, p.255., Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: Given as Deepana Pachana for initial five days and later after five days other medicines are started.(2) Medicine Name: Jeevaniya Taila Nasya, Reference: Vaidya Lakshmipati Shashtri. Yogaratnakara reprint edition 2020, Varanasi; Chaukhambha Prakashan, Vataviparya Shushkakshipaka Chikitsa Shloga5, p.392., Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Marsha Nasya (6-6 drops) both nostrils will be given to the patients for a duration of seven days later a gap of seven days will be given and then again a sitting of seven days will be given to the patients means two sittings will be given in a duration of 28 days. | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shunthyadi Ghan Vati, Reference: Prof. Siddhi Nandan Mishra. Bhaisajya Ratnavali of Kaviraj Govind Das Sen, reprint edition 2021, Varanasi; Chaukhambha Surbharati Prakashan, 8/6, p.255., Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: Given as Deepana Pachana for initial five days and later after five days other medicines are started.(2) Medicine Name: Saindhavadya Anjana, Reference: Vaidya Lakshmipati Shashtri. Yogaratnakara reprint edition 2022,Varanasi; Chaukhambha Prakashan, Vataviparya Shushkakshipaka Chikitsa Shloga 4, p.392., Route: Ocular, Dosage Form: Ghrita, Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: 1 drop in each Eye, Topically in form of Eye drop
(3) Medicine Name: Jeevaniya Taila Nasya, Reference: Vaidya Lakshmipati Shashtri. Yogaratnakara reprint edition 2020, Varanasi; Chaukhambha Prakashan, Vataviparya Shushkakshipaka Chikitsa Shloga5, p.392., Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Marsha Nasya (6-6 drops) both nostrils will be given to the patients for a duration of seven days later a gap of seven days will be given and then again a sitting of seven days will be given to the patients means two sittings will be given in a duration of 28 days.
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between 18 to 55 years of age and willing to participate in this study through written consent are recruited.
2.Patients utilizing a Computer or Video Display Terminals VDTs for a minimum of two hours each day and presenting with minimum three of clinical features of Shushkakshipaka Computer Vision Syndrome such as Kunita Vartma Photophobia, Avila Darsana Blurring of vision, Gharsa Foreign body sensation, Toda Asthenopia, Ushnadaha Burning sensation, Vishushkatva Dryness of eyes, Raga Conjunctival congestion.
3.Patients with OSDI score from Mild 13 to 22 to Moderate 23 to 32 will be included in the study.
|
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| ExclusionCriteria |
| Details |
1.Individuals under the age of 18 and those over the age of 55 are not included in the study.
2.Cases that are complicated by Acute or Chronic infection of Conjunctiva, Eyelid, Cornea, Dacryocystitis, Lagophthalmos, Sjogrens Syndrome.
3.Pregnant and lactating women are excluded in the study.
4.Patients with severe systemic illnesses that could hamper the trial in between are excluded.
5.Severe patients of Computer Vision Syndrome with complications like Corneal Ulcer. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Ocular Surface Disease Index (OSDI) score in Shushkakshipaka (Computer Vision Syndrome). |
Improvement in OSDI score from baseline to the end of 33 days treatment period, indicating relief in Shushkakshipaka (Computer Vision Syndrome). |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Schirmer-1 reading, Tear Film Break-Up Time, Ocular Surface Staining grading and subjective Ocular symptoms grading in Shushkakshipaka (Computer Vision Syndrome). |
Improvement in Schirmer-1 reading, Tear Film Break-Up Time, Ocular Surface Staining grading and subjective Ocular symptoms grading from baseline to the end of 33 days treatment period, indicating relief in Shushkakshipaka (Computer Vision Syndrome). |
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Computer Vision Syndrome CVS, also known as Digital Eye Strain, is an emerging public health concern caused by prolonged use or extended exposure to video display terminals VDTs including devices such as computers, tablets, e-readers, and mobile phones. Computer Vision Syndrome presents with a spectrum of visual, ocular, and extraocular symptoms with dry eye being a central component. In Ayurveda, this condition closely resembles Shushkakshipaka, a disease described in classical texts as Sarvagata Netraroga diseases affecting all regions of the eye. Allopathy presents limited interventions and often comes with long-term drawbacks. Ayurveda, with its holistic approach, offers promising solutions through systemic and local therapies. This randomized comparative clinical trial is designed to evaluate the efficacy of Saindhavadya Anjana and Carboxy Methyl Cellulose CMC Eye Drops, each in combination with Jeevaniya Taila Nasya, in the management of Shushkakshipaka Computer Vision Syndrome. The study aims to provide a cost-effective, safe, and efficient alternative for managing Computer Vision Syndrome CVS symptoms through integrative Ayurvedic interventions. HYPOTHESIS Null Hypothesis H0
There is no difference in efficacy of Saindhavadya Anjana and Carboxy Methyl Cellulose Eye Drop, each combined with Jeevaniya Taila Nasya, in the management of Shushkakshipaka with special reference to Computer Vision Syndrome. Alternative Hypothesis H1
There is a difference in efficacy of Saindhavadya Anjana and Carboxy Methyl Cellulose Eye Drop, each combined with Jeevaniya Taila Nasya, in the management of Shushkakshipaka with special reference to Computer Vision Syndrome. AIM AND OBJECTIVES AIM
To compare the efficacy of Saindhavadya Anjana and Carboxy Methyl Cellulose Eye Drop, each combined with Jeevaniya Taila Nasya, in the management of Shushkakshipaka with special reference to Computer Vision Syndrome. OBJECTIVES -
To evaluate the efficacy of Saindhavadya Anjana combined with Jeevaniya Taila Nasya in the management of Shushkakshipaka with special reference to Computer Vision Syndrome. -
To evaluate the efficacy of Carboxy Methyl Cellulose Eye Drop combined with Jeevaniya Taila Nasya in the management of Shushkakshipaka with special reference to Computer Vision Syndrome. |