| CTRI Number |
CTRI/2025/08/093495 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| 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
|
Effect OF NANAMRUTA LAUHAM an Ayurvedic eye tonic on vision loss due to age related denegerative macular disease |
|
Scientific Title of Study
|
Effect Of Nayanamruta Lauham On Drishtipatalagata Vyadhi With Reference To Age Related Macular Degeneration A Clinical Study |
| 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.Yuwaraj D.Kale |
| Designation |
Ph.D. Scholar, Professor, Head Department of Shalakyatra |
| Affiliation |
Bhausaheb Mulak Ayurved Mahavidyala And Medical Science Research Hospital |
| Address |
Department of Shalakyatntra, Government Ayurved College, Raghuji Nagar Nagpur
Department Of Shalakyatantra Bhausaheb Mulak Ayurved Mahavidyalaya And Medical Science Research Hospital Great Nag Road Nandanvan Nagpur
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9881716000 |
| Fax |
|
| Email |
rajkale.dhanprabha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. H. N. Umale |
| Designation |
Guide, HOD, Department of Shalakyatantra |
| Affiliation |
Professor and Head, Department of Shalakyatantra |
| Address |
Department of Shalakyatntra Government Ayurved College Raghuji Nagar Nagpur
Bhausaheb Mulak Ayurved Mahavidyalaya, Nandanvan, Nagpur
Nagpur
MAHARASHTRA
440009
India |
| Phone |
|
| Fax |
|
| Email |
hariumale58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Yuwaraj D. Kale |
| Designation |
Professor and Head of Department |
| Affiliation |
Bhausaheb Mulak Ayurved Mahavidyala And Medical Science Research Hospital |
| Address |
Department Of Shalakyatantra Bhausaheb Mulak Ayurved Mahavidyalaya And Medical Science Research Hospital Great Nag Road Nandanvan Nagpur
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9881716000 |
| Fax |
|
| Email |
rajkale.dhanprabha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College, Raghuji Nagar, Nagpur-440009 Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
NIL |
| 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 Yuwaraj D Kale |
Government Ayurved College Nagpur |
Shalakyatantra OPD, Government Ayurved College, Raghuji Nagar, Nagpur-440009
Nagpur
MAHARASHTRA |
09881716000
rajkale.dhanprabha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Government Ayurved College Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H353||Degeneration of macula and posterior pole. Ayurveda Condition: DRUSHTIMADHYAGATA-DOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nayanamruta Lauham , Reference: Rasaratna Sammucchaya , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | cap antioxidant | 500 mg OD after meal for 3 months | | 3 | Comparator Arm (Non Ayurveda) | | - | cap antioxidant | 500 mg OD after meal for 3 months |
|
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age related Macular Degeneration |
|
| ExclusionCriteria |
| Details |
Diabetic Retinopathy Hypertensive Retinopathy CRAO Iridocyclitis RD Glaucoma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Best-Corrected Visual Acuity (BCVA) in logMAR in the study eye from baseline. |
at baseline,after 7 day,15 day,1 month ,2 month ,3 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in central macular thickness (CMT) on Spectral-Domain OCT from baseline.
Change in drusen area/volume or presence/progression of geographic atrophy on OCT/fundus photo grading (AREDS categories).Change in patient-reported vision-related quality of life |
at baseline,after 7 day,15 day,1 month ,2 month ,3 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="0"
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
|
This is a prospective, parallel arm, open-label clinical study designed to evaluate the effect of Nayanamruta Lauham in the management of Drishtipatalagata Vyadhi with reference to Age-Related Macular Degeneration (AMD). A total of 60 participants diagnosed with non-neovascular AMD will be enrolled. Eligible participants will receive Nayanamruta Lauham as per protocol for a duration of 3 months (12 weeks) with follow-up assessments at baseline, 4 weeks, 8 weeks, and 12 weeks. The primary outcome is the change in Best Corrected Visual Acuity (BCVA) from baseline to 12 weeks. Secondary outcomes include changes in contrast sensitivity, central macular thickness (OCT), metamorphopsia (Amsler grid), and vision-related quality of life (NEI VFQ-25). Safety assessments will include monitoring of adverse events and routine laboratory investigations. The study aims to explore the clinical efficacy and safety of Nayanamruta Lauham as an Ayurvedic intervention for improving visual function in patients with dry AMD. |