| CTRI Number |
CTRI/2026/01/100157 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| 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
|
A Study on the efficacy of Ayurvedic therapies like Jeevantyadi Taila Nasya, Shatahwadi Ghrita Tarpana along with oral intake of Rasayana Ghana Vati in the management of Age related Vision loss as compared to the prevalent multivitamin supplement therapy. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Jeevantyadi Taila Nasya,Shatahwadi Ghritha Tarpana and Rasayana Ghana Vati oral intake in Vataja Timira with special reference to Dry Age related Macular Degeneration |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharanya A |
| Designation |
MS Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Shalakya Tantra
National Institue of Ayurveda
Jorawar Singh Gate
Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9207425908 |
| Fax |
|
| Email |
sharanyanair20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhakar Vardhan |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no. 313
Department of Shalakya Tantra
National Institue of Ayurveda
Jorawar Singh Gate
Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461065960 |
| Fax |
|
| Email |
shalakya007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabhakar Vardhan |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no. 313
Department of Shalakya Tantra
National Institue of Ayurveda
Jorawar Singh Gate
Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461065960 |
| Fax |
|
| Email |
shalakya007@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institue of Ayurveda
Jorawar Singh Gate
Amer Road
Jaipur - 302002
|
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Department of Shalakya Tantra
National Institute of Ayurveda
Jorawar Singh Gate
Amer Road
Jaipur 302002
|
| 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 Sharanya A |
National Institute of Ayurveda Hospital |
OP Department of Shalakya Tantra
Room number 14
National Institute of Ayurveda
Jorawar Singh Gate
Amer Road 302002
Jaipur
RAJASTHAN |
9207425908
sharanyanair20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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: TIMIRAHÂ (KEVALAVATA), (2) ICD-10 Condition:H353||Degeneration of macula and posterior pole. Ayurveda Condition: TIMIRAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Erandabrishta Haritaki, Reference: Chakrapani, Chakradatta, Chikitsa Sthana 25/11, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: Initial Koshta Shuddhi | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasayana Ghan vati, Reference: Ashtanga Hridaya, Uttarasthana 39/159, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu and ghrita in unequal quantity), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jeevantyadi Taila, Reference: Ashtanga hrdaya uttara 13/51,52,53, Route: Nasal, Dosage Form: Taila, Dose: 1(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: Nasya | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatahwadi ghrita, Reference: Ashtanga Hridya Uttara 13/548, Route: Ocular, Dosage Form: Ghrita, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: Tarpana | | 5 | Comparator Arm (Non Ayurveda) | | - | I- SITE CAPSULE | 1 Capsule OD for 30 days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with classical signs and symptoms of Vataja Timira i.e. blurred vision (Avila darshana), distorted vision (Vyavidham darshana), central scotoma (Pashyathi asyam anasikam), metamorphopsia (Vakram riju api manyate)
2.Early to intermediate forms of Dry AMD ie presence of Drusens and AMD changes in retina. |
|
| ExclusionCriteria |
| Details |
1. Presence of any other retinal or macular pathology other than Non-Exudative AMD such as Exudative AMD Diabetic retinopathy Central geographic atrophy Hemorrhagic condition of fundus or retinal fluid.
2. History of retinal laser or surgical therapy in study eye.
3. Contraindication of pupil dilatation in the study eye.
4. Mature cataract or media opacification in either eye which limits an adequate view of fundus.
5. Unable to maintain stable fixation for OCT imagining.
6. Patient having systemic disorders that may confound or alter the course of AMD.
7. Patients who are contraindicated for any of the trial or control drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Drusen levels |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in visual acuity (BCVA), Changes in Macular thickness |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
11/11/2026 |
| 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="1"
Months="6"
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
|
Age related Macular Degeneration is a major cause of irreversible central vision loss in the elderly, with limited effective treatment options in contemporary ophthalmology. Existing therapies provide suboptimal outcomes and lack strong evidence of long term benefit. Therefore , there is a need to explore safe , effective and evidence based alternative interventions to improve visual function and quality of life in patients with ARMD.This study aims to check whether
Jeevantyadi Taila Nasya and Shatahwadi Ghritha Tarpana along with
Rasayana Ghana Vati oral intake is effective in the management of Vataja Timira with special reference to Dry
Age -related macular degeneration as
compared to that of prevalent
Multivitamin and Antioxidant supplement therapy? |