| CTRI Number |
CTRI/2026/02/103348 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to explore additional effects of Ayurvedic Fennel Eye Drops with Timolol eye drops in Glaucoma patients |
|
Scientific Title of Study
|
Randomized controlled clinical study to assess the add-on effect of Mishreya (Foeniculum vulgare) Ark ashchyotan with Timolol eye drops in primary open angle glaucoma (POAG) with special reference to Kaphaja Adhimantha. |
| Trial Acronym |
MARK eye drops |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dipti Nene |
| Designation |
Professor |
| Affiliation |
Ayurved Vidya Prasarak Mandals Ayurved Mahavidyalay, Sion |
| Address |
3ed floor, Main building, Department of Shalakyatantra, Ayurved Vidya Prasarak Mandals Ayurved Mahavidyalay, Sion (E), Mumbai, Near Sion Railway Station, Sion (E), Mumbai City
Thane
MAHARASHTRA
400022
India |
| Phone |
9987005997 |
| Fax |
|
| Email |
dipti.nene@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravidas Wamanrao More |
| Designation |
Incharge Principal, Professor, HOD (Department of Shalakyatantra) |
| Affiliation |
Ayurved Vidya Prasarak Mandals Ayurved Mahavidyalay Sion |
| Address |
Principal cabin, 1st floor, Main building, Ayurved Vidya Prasarak Mandals Ayurved Mahavidyalay, Sion (E), Mumbai, near Sion railway station, Mumbai City
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9967483930 |
| Fax |
|
| Email |
ravimore67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravidas Wamanrao More |
| Designation |
Incharge Principal, Professor, HOD (Department of Shalakyatantra) |
| Affiliation |
Ayurved Vidya Prasarak Mandals Ayurved Mahavidyalay Sion |
| Address |
Principal cabin, 1st floor, Main building, Ayurved Vidya Prasarak Mandals Ayurved Mahavidyalay, Sion (E), Mumbai, near Sion railway station, Mumbai City
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9967483930 |
| Fax |
|
| Email |
ravimore67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Vidya Prasarak Mandals Ayurved Mahavidyalay, Sion (E), Mumbai, Near Sion Railway Station, Sion (E), Mumbai city 400022 |
|
|
Primary Sponsor
|
| Name |
Ayurved Vidya Prasarak Mandals Ayurved Mahavidyalay, Sion |
| Address |
Ayurved Vidya Prasarak Mandals Ayurved Mahavidyalay, Sion (E), Mumbai, Near Sion Railway Station, Sion (E), Mumbai city 400022 |
| 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 Dipti Nene |
APMs Ayurved Mahavidyalay, |
OPD No. 1, Dept of Shalakya Tantra, APMs Ayurved Mahavidyalay, Near Sion Railway staion, Sion, Mumbai 400022
Mumbai
MAHARASHTRA |
9987005997
dipti.nene@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, APMs Ayurved Mahavidyalay, Sion |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H401||Open-angle glaucoma. Ayurveda Condition: ADHIMANTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | AScyotanam, आश्च्योतनम् | (Procedure Reference: Ark Prakash & Sushrut Samhita, Procedure details: In morning patient is
asked to lie down in supine
position. Affected eye is cleaned.
Contact lens are removed if
used by the patient. 8 drops of Mishreya Ark is instilled in the affected eye from the height of 2 angul (fingers). Cleaning of eye
is done. Patient is allowed to
rest for few minutes.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Timolol | Patient lies in supine position. Eye is opened with lids apart. Timolol OD eye drops 1 drop is instilled in affected eye at night |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
40 -70 years old patient of POAG, with IOP less than 30 mm of Hg, CDR less than 0.7, visual acuity more than 6/60 |
|
| ExclusionCriteria |
| Details |
1. Patients with all types of PCAG, cataract, secondary and developmental glaucoma including exfoliative glaucoma, pigmentary glaucoma, trauma induced inflammatory glaucoma, advanced glaucomatous optic neuropathy or optic atrophy.
2. Visual acuity less than 6/60
3. known cases of bronchial asthma, cardiac diseas or patient on steroid treatment |
|
|
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 |
1. To assess the changes in subjective symptoms of POAG (Kaphaj Adhimantha) in group A and group B.
2. To assess the pre and post study changes in BCVA, IOP, MD in Perimetry, NPA in RAF rule in group A and group B.
3. To study the efficacy of Mishreya Ark Ashchyotan and Timolol eye drops in POAG.
|
at baseline, 10th day, 20th day, 30th day, 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
3. To study Mishreya ark in detail
4. To study Ashchyotan in deatil and prepare its SOP.
3. To study probable mode of action of Mishreya Ark Ashchyotan. |
at baseline, 10th day, 20th day, 30th day, 60th day |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
19/02/2026 |
| 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="2"
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 POAG (Kaphaj Adhimantha ) will be informed about the trial and written consent will be taken. Interventions to both the groups will be given. assessment will be done based on subjective criteria 1. headache 2. ocular pain 3. difficulty in near vision objective criteria 1. BCVA 2. IOP 3. MD of perimetry 4. NPA on RAF rule. Data will be obtained and stastistical analysis will be done. Observations and results will be done based on statistical analysis. |