| CTRI Number |
CTRI/2025/11/096836 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| 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
|
Role of Ayurvedic Nasya Therapy in Managing Dry Age Related Vision Loss. |
|
Scientific Title of Study
|
Effectiveness of Triphala Ghrita Nasya along with Antioxidant Therapy and Antioxidant Therapy alone in the management of Vataja Timira with Reference to Age Related Macular Degeneration (Dry type)- A Randomized 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 Rutika Sainath Hamare |
| Designation |
PG scholar |
| Affiliation |
Dr.G.D.Pol Foundation ,YMT Ayurvedic Medical College and Hospital |
| Address |
OPD No.25.Shalakyatantra Department,Ground floor,Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College and Hospital PG Institute.Institutional Area Sector 4 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9637833058 |
| Fax |
|
| Email |
r.hamare96.20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nutan Radaye |
| Designation |
Head Of Department |
| Affiliation |
Dr.G.D.Pol Foundation ,YMT Ayurvedic Medical College and Hospital |
| Address |
OPD No.25.Shalakyatantra Department,Ground floor,Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College and Hospital PG Institute.Institutional Area Sector 4 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9820512695 |
| Fax |
|
| Email |
nutan.radaye.nr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nutan Radaye |
| Designation |
Head Of Department |
| Affiliation |
Dr.G.D.Pol Foundation ,YMT Ayurvedic Medical College and Hospital |
| Address |
OPD No.25.Shalakyatantra Department,Ground floor,Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College and Hospital PG Institute.Institutional Area Sector 4 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9820512695 |
| Fax |
|
| Email |
nutan.radaye.nr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.G.D.Pol Foundation, YMT Ayurvedic Medical College and Hospital PG Institute.Institutional Area Sector 4 Kharghar Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Rutika Sainath Hamare |
| Address |
OPD NO.25.Shalakyatantra Department,Ground Floor, Dr.G.D.Pol Foundation,YMT
Ayurvedic Medical College and Hospital PG institute.Institutional Area Sector 4 Kharghar Navi Mumbai |
| 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 Rutika Sainath Hamare |
Dr.G.D.Pol Foundation, YMT Ayurvedic Medical College and Hospital |
OPD NO.25.Shalakyatantra Department,Ground Floor,Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College and Hospital PG Institute. Institutional Area Sector 4 Kharghar Navi Mumbai.
Raigarh
MAHARASHTRA |
9637833058
r.hamare96.20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Dr G.D.Pol Foundation YMT Ayurvedic medical college and charitable hospital |
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: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Nasya | (Procedure Reference: Ashatang Hrudaya sutrasthan chapter 20, shlok 17, Procedure details: (Procedure Reference: Ashatang hrudaya sutrasthana chapter 20, shlok 17, Procedure details: 1)Patient is made to lie down in supine position. 2)Sthanik Snehan on face with Triphala Ghrital. 3)Nadi Swedana on face with wet cotton pad covering eyes. 4)Ghrita is slightly warmed in luke warm water. 5)Patients neck is slightly extended, & tip of the nose is lifted with left thumb & index finger 6)Marsha Nasya of Triphala Ghrita 8 Bindu- With the help of dropper are installed in one nostril first while closing the other & vice versa. 7)Slight massage on face in upward direction from the nostril to forehead will be given to patient. 8)Excess Ghrita coming in the mouth will be asked to spit out. 9)Patient will be asked to relax in supine position 10)Gandush with lukewarm water is given.medicine name : Triphala Ghrita Reference : Ashatang Hrudaya Route : nasal Dosage form: tail dose:8 drops Frequency :od duration :21 days )
| | 2 | Comparator Arm (Non Ayurveda) | | - | Antioxidant | Antioxidant with content like vit c, zeaxanthin,zinc,copper will be given for 21 days |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patient with distant vision less than equal to 6/9 with symptoms like bhramativa darshana (objects seems to be moving) avila darshana (blur vision) arunah darshana (slight red) vyavidha darshana (metamorphopsia). |
|
| ExclusionCriteria |
| Details |
1.retinal diseases except ARMD dry type
2.systemic diseases which affect macula like uncontrolled DM , hypertention.
3.cataract patients
4.patients contraindicated for nasya |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Triphala Ghrita Nasya and Antioxidant Therapy is significantly effective than Antioxidant Therapy only in symptoms of Vataj Timir with reference to Age Related Macular Degneration (Dry Type) |
0th,7th,14th,21st,28th and 42nd day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Triphala Ghrita Nasya and Antioxidant Therapy is not significantly effective than Antioxidant Therapy only in symptoms of Vataj Timir with reference to Age Related Macular Degneration (Dry Type) |
0th,7th,14th,21st,28th and 42nd day. |
|
|
Target Sample Size
|
Total Sample Size="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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
|
this is randomized controlled clinical trial assessing the effectiveness of Triphala Ghrit Nasya and Antioxidant with Antioxidant therapy only given for 21 days in 60 patients will be observed for 42 days. the primary outcome is to see effect of treatment on Vataja Timira (ARMD)symptoms .secondary outcome is to see on visual acuity , amsler grid, peli robson chart contrast sensitivity chart . |