| CTRI Number |
CTRI/2025/08/093635 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [PhD Thesis] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of drying of eye with eye massage |
|
Scientific Title of Study
|
Randomized control Clinical trial on efficacy of Ushiradi
Taila Netrabhyanga in comparison with Hydroxypropyl
Methylcellulose eye gel in the management of
Shushkashipaka with special reference to dry eye disease |
| 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 Nikhil Naganath Mali |
| Designation |
Associate Professor(Ph D Scholar) |
| Affiliation |
Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion |
| Address |
3rd floor, main building Department of Shalakya Tantra, Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion (E), Mumbai,
Near Sion Railway Station,Sion(E), Mumbai City
3rd floor, main building Department of Shalakya Tantra,Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion (E), Mumbai,
Near Sion Railway Station,Sion(E), Mumbai City
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9421300591 |
| Fax |
|
| Email |
nikhayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravidas Wamanarao More |
| Designation |
Inchage principal,Professor, HOD(Department of Shalakyatantra) |
| Affiliation |
Inchage principal,Professor, HOD(Department of Shalakyatantra)Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion |
| Address |
Principal cabin, 1st floor, Main Building, Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion (E), Mumbai,
Near Sion Railway Station,Sion(E), Mumbai City
Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion (E), Mumbai,
Near Sion Railway Station,Sion(E), Mumbai City
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9967483930 |
| Fax |
|
| Email |
ravimore67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil Naganath Mali |
| Designation |
Associate Professor(Ph D Scholar) |
| Affiliation |
Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion |
| Address |
3rd floor, main building Department of Shalakya Tantra,Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion (E), Mumbai,
Near Sion Railway Station,Sion(E), Mumbai City
3rd floor, main building Department of Shalakya Tantra,Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion (E), Mumbai,
Near Sion Railway Station,Sion(E), Mumbai City
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9421300591 |
| Fax |
|
| Email |
nikhayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion (E), Mumbai,
Near Sion Railway Station,Sion(E), Mumbai City 400022 |
|
|
Primary Sponsor
|
| Name |
Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion |
| Address |
Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion (E), Mumbai,
Near Sion Railway Station,Sion(E), Mumbai City |
| 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 Nikhil Mali |
APMs Ayurved Mahavidyalaya, Sion |
A. P. M.’s Ayurved Mahavidyalaya, Sion
Institute of Research Centre affiliated to Maharashtra University of
Health Sciences, Nashik
Mumbai
MAHARASHTRA |
09421300591
nikhayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,APM Ayurved Mahavidyalaya, Sion |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H048||Other disorders of lacrimal system. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Netrabhyanga | (Procedure Reference: Netraprakashika 14th Chapter- Tailanirnayam, Shloka 49-52 , Procedure details: Patient is asked to lie down in supine position. Eyes are cleaned. Contact lens are removed if used by the patient. Warm oil is pour on eyelids with fingertips & gentle massage is done. Repeat the procedure for the other eye. Cleaning of eyes is done. Patient is allowed to rest for few minutes.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Hydroxypropyl Methylcellulose eye gel | local application of gel for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms of Shushkaakshipaka, patients of age group 40 years to 60 years, are randomly selected to maintain homogeneity. Patients suffering from DED are selected irrespective of gender or socioeconomic status. Patients with scores less than 15 mm on Schirmer’s test. |
|
| ExclusionCriteria |
| Details |
Patients with age groups below 40 years and above 60 years are excluded. Patients suffering from ophthalmic infective diseases are excluded. Patients with other major ophthalmic diseases like glaucoma, retinal abnormality are excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the changes in subjective symptoms of Dry eye Disease
(Shushkakshipaka) in group A and group B.
2. To assess the pre and post study changes in Schirmer’s test, BUT test and Rose
Bengal Test in group A and group B.
To study the efficacy of Ushiradi taila netrabhyanga and HPMC gel in dry eye
disease.
2. To study ushiradi taila in detail.
3. To study netrabhyanga in detail and to prepare SOP of it.
4. To study probable mode of action of netrabhyanga in detail.
5. To study HPMC Gel and its properties. |
at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Ushiradi taila netrabhyanga and HPMC gel in dry eye
disease.
2. To study ushiradi taila in detail.
3. To study netrabhyanga in detail and to prepare SOP of it.
4. To study probable mode of action of netrabhyanga in detail.
5. To study HPMC Gel and its properties. |
at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/09/2025 |
| 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="0"
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
|
Patients with confirmed diagnosis of Shushkashipaka(dry eye disease)will be informed about the trial and written consent will be taken. Interventions to both the groups will be given and assessment will be done based on which stastistical analysis will be made. Observations and results will be done based on statistical analysis |