| CTRI Number |
CTRI/2024/08/071770 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Topical Admistration] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Yasthimadhu Anjana in Dry Eye W.S.R to the status of Tear Film |
|
Scientific Title of Study
|
Efficacy of Yasthimadhu Anjana in Dry Eye W.S.R to the status of Tear Film A Randomised controlled clinical trial |
| 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 Koushik |
| Designation |
P G Scholar |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 Karnataka India |
| Address |
Dr KOUSHIk 1st year Pg schooler department of Shalakya tantra opd no 27 chakshyshya KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 Karnataka India
Belgaum
KARNATAKA
590003
India |
| Phone |
7259985998 |
| Fax |
|
| Email |
koushikgumdal500@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arunkumar Bapura Biradar |
| Designation |
Professor |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Dr Arun kumar biradar opd no 27 chakshushya opd departmentb of shalakya tantra KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9964064955 |
| Fax |
|
| Email |
arunkumar.biradar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunkumar Bapura Biradar |
| Designation |
Professor |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Dr Arun kumar Biradar opd no 27 chakshushya opd departmentb of shalakya tantra KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9964064955 |
| Fax |
|
| Email |
arunkumar.biradar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Hospital Shahapur Belagavi 590003 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Koushik |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi |
| Type of Sponsor |
Other [Self] |
|
|
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 Koushik |
KAHER BMkankanwadi Ayurveda Hospital and MRC |
OPD No 27 Department of Shalakyatanta KAHER Shri B M Kankanwadi Ayurveda Hospital Shahapur Belagavi
Belgaum
KARNATAKA |
7259985998
koushikgumdal500@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for research on human subjects |
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 | Drug | Other than Classical | | (1) Medicine Name: Yasthimadhu Anjana, Reference: NA, Route: Topical, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Yasthimadhu Anjana is applied topically for 30 days once in a day | | 2 | Comparator Arm (Non Ayurveda) | | - | Dephantenol opthalmic gel | Dephantenol opthalmic gel
Topically Administered for 30 days HS |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria of Dry Eye Syndrome i e Schimers Test and Tear break up time
18 to 40 years of age group
Irrespective of gender occupation religion will be included
|
|
| ExclusionCriteria |
| Details |
Severe conditions of ocular surface disorders
Severe conditions like Steven Johnsons syndrome Chemical Thermal Radiation burns idiopathic atrophy Trachoma Ocular pemphigoid Sjogrens Syndrome
Corneal epitheliopathies like Neuroparalytc keratitis post herpetic post measles infection of cornea
Conjunctival epitheliopathies like Pterygium Pseudo pterygium Tumors Retention cysts chronic low grade bacterial viral conjunctivitis
Lid abnormalities like Meibomitis Blepharitism mFacial nervepalsy Lagophthalmos
Lacrimal gland diseases like infiltration of gland with sarcoidosis lymphoma leukemia and amyloidosis congenital Alacrimia
Vitamin A deficiency effect of the drugs like atropine antihistamine diuretics
Specific systemic infections like Tuberculosis Leprosy Hypertension RA Diabetes mellitus etc
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Yastimadhu Anjana may show effect in changing the status of Tear Film |
0th Day 15th Day 30th Day 45th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| Date of Study Completion (India) |
30/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 Study comparative efficacy of Yasthimadhu anjana with Depanthenol opthalmic gel 5% in Dry Eye with special reference to status of tear film A Randomized Controlled clinical trial comparing both groups for 30 days Study will be conducted in KAHER Shri B M Kankanwadi ayurveda Mahavidylaya and Research center owned KLE Ayurveda Hospital shahapur Belagavi Karnataka India . The expected outcome is to bring the status of tear film qualitatively and quantitatively at its normal level.
|