| CTRI Number |
CTRI/2025/03/083421 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the Effect of Haridradi Anjana in shushkakshipaka with reference to Dry Eye Syndrome |
|
Scientific Title of Study
|
Open Randomised Control Clinical Trial of Haridradi Anjana in Shushkakshipaka with Special Reference to Dry Eye 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 Swapnil Madan Bilari |
| Designation |
Post Graduate Student |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate research centre Ashta |
| Address |
Shalakyatantra department, 5th floor , Hon. Shri Annasaheb Dange Ayurved Medical College and Post Graduate research centre, Ashta , Tal. walwa , Dist. Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8624020686 |
| Fax |
|
| Email |
swapnilbilari31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Kate |
| Designation |
Head of Department, Shalakyatantra |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate research centre Ashta |
| Address |
Shalakyatantra department, 5th floor , Hon. Shri Annasaheb Dange Ayurved Medical College and Post Graduate research centre, Ashta , Tal. walwa , Dist. Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9404701645 |
| Fax |
|
| Email |
drsujatakate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Kate |
| Designation |
Head of Department, Shalakyatantra |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate research centre Ashta |
| Address |
Shalakyatantra department, 5th floor , Hon. Shri Annasaheb Dange Ayurved Medical College and Post Graduate research centre, Ashta , Tal. walwa , Dist. Sangli
MAHARASHTRA
416301
India |
| Phone |
9404701645 |
| Fax |
|
| Email |
drsujatakate@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate research centre Ashta, Tal Walwa , Dist Sangli 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Swapnil Madan Bilari |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate research centre Ashta Tal Walwa Dist Sangli 416301 |
| Type of Sponsor |
Other [] |
|
|
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 Swapnil Madan Bilari |
OPD no. 2 , Netra OPD, Dhanvantari Rugnalay, Ashta |
5th floor, Shalakyatantra Department, Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate research centre Ashta Tal Walwa Dist Sangli 416301
Sangli
MAHARASHTRA |
8624020686
swapnilbilari31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate research centre INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H049||Disorder of lacrimal system, unspecified. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haridradi Anjana , Reference: Sushrut samhita Uttartantra Adhayay 9 Shlok No 23, Route: Ocular, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 25(mg), Frequency: hs, Bhaishajya Kal: Samudga, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Hydroxypropylmethylcellulose 2% eye gel | Hydroxypropylmethylcellulose 2 % Eye gel HS for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from symptoms of shuskakshipak(Netrashushkata, Daha ,Gharsha, Aavildarshanam, Krichronmeelanimeelana, etc.)
2. Patients of age group between 18-70yrs irrespective of gender,socioeconomical status, religious status.
3. Patients having excessive outdoor and indoor work exposed to sunlight for more than 3hrs.
4. Patients having software profession, those who gets exposed to visual devices daily for longer duration more than 3 hrs.
5. Patients willing to take part in treatment. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haridradi Anjana is effective in Shushkashipaka |
Once a day for 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hydroxymethylcellulose 2 % eye gel is effective in Shushkashipaka |
Once in night for 7 days |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
07/04/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The condition is more common among the people irrespective of their age. Dry Eye Syndrome can have remarkable impact on visual function, daily activities, social and physical functioning, workplace productivity and quality of life. Recently due to Covid Crises use of visual electronic devices has been increased tremendously. This is adversely affecting the eye health. Extended period of visual device use may lead to eye-strain, dryness of eyes, vision related problems and many more.
While working in Shalakyatantra (Netrarog) OPD researcher sees a good number of patients with the complaints of the same. This (4)provoked to study on this disease, as Prevalance ranges from 5% to 35% worldwide. While in India it is 29.25% based on ocular surface disease index data
|