| CTRI Number |
CTRI/2025/03/081943 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An assessment of effectiveness of Abhijeet Tail Nasya Viddhakarma and Antioxidant Therapy in symptoms of Vataja Timir (Age Related Macular Degeneration-Dry Type). |
|
Scientific Title of Study
|
An assessment of effectiveness of Abhijeet Tail Nasya Viddhakarma and Antioxidant Therapy with Antioxidant Therapy only in symptoms of Vataja Timir w.r.t 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 Siddhi Dichwalkar |
| Designation |
PG scholar |
| Affiliation |
Maharashtra University health science, Nashik |
| Address |
YMT Ayurvedic Medical College and Hospital,Shalakya Tantra Department,Ground Floor,Institutional Area,Sector 4,Kharghar,Navi Mumbai Raigarh
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9594695930 |
| Fax |
|
| Email |
siddhi904@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nutan Radaye |
| Designation |
Head Of Department |
| Affiliation |
YMT Ayurvedic Medical College ,sector 4,kharghar,Navi Mumbai |
| Address |
YMT Ayurvedic Medical College and Hospital,Shalakya Tantra Department,Ground Floor,Institutional Area,Sector 4,Kharghar,Navi Mumbai Raigarh
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 |
YMT Ayurvedic Medical College ,sector 4,kharghar,Navi Mumbai |
| Address |
YMT Ayurvedic Medical College and Hospital,Shalakya Tantra Department,Ground Floor,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
|
| YMT Ayurvedic Medical College and Hospital,Shalakya Tantra Department,Sector 4,Kharghar,Navi Mumbai
Maharashtra 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Siddhi Dichwalkar |
| Address |
A-3,904,Mohan Pride,Waylenagar,Kalyan West,Near Podar School,thane,421301 |
| 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 Siddhi Dichwalkar |
YMT Ayurvedic Medical College and Hospital |
OPD and IPD Of Shalakya Tantra Department YMT Ayurvedic Medical College and Hospital,Ground Floor,Institutional Area,Sector 4,Kharghar,Navi Mumbai Raigarh,Maharashtra
Raigarh
MAHARASHTRA |
9594695930
siddhi904@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: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vyadhana-visrAvaNa-karma, व्यधन-विस्रावण-कर्म | (Procedure Reference: sushruta sharir chapt 8 shlok 4, Procedure details: After Nasya karma is done written consent will be taken
Upanasika Lalaat & Apanga site will be cleaned with a spirit solution swab
Patient will be asked to site comfortable with thumbs touching their respective palms & fists clenched tightly
26 no half inch needle is held perpendicular to the site of Asravisravan & a prick of 2 to 4 mm deep will be taken at Upanasika Lalaat & Apanga site each on the respective side of the face
Blood oozing out from prick site will be wiped with sterile cotton swab
Needle used will be disposed off)
| | 2 | Comparator Arm (Non Ayurveda) | | - | antioxidant | antioxidant with content like vit c,vit E,lutein,zeaxanthin,zinc,copper will be given for 21 day | | 3 | Intervention Arm | Procedure | - | nasyam, नस्यम् | (Procedure Reference: Ashtanga Hrudaya sutrastana chapter 20,shlok 17, Procedure details: patient is made to lie in supine position. stanik snehana with tila tail & swedana is done. patient neck is slightly extended, & tip of nose is lifted with left thumb & one side nostril is closed. with help of dropper abhijeet tail 8 drop is instilled in one nostril & then in other. slight massage on face in upward direction from nostril to forehead is done. excess oil coming in mouth is asked to spit out. gandush with lukewarm water is done. ))
(1) Medicine Name: Abhijeet tail , Reference: Bhaishaja ratnavali 64,274-275, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with distant vision less than or equal to 6/9 with symptoms like Bhramativa Darshana (objects seems to be moving), Aavila Darshana (blur vision),Vyavidha Darshana (metamorphopsia) will be taken
|
|
| ExclusionCriteria |
| Details |
1.retinal diseases except ARMD dry type.
2.systemic diseases which affect macula like uncontrolled DM,hypertension,HIV,HbsAg diseases, psychiatric disorders
3.cataract patients.
4.Patients contraindicated for Nasya and siravedha.
5.patient with skin diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Abhijeet Tail Nasya,Viddhakarma and Antioxidant Therapy is significantly effective than Antioxidant Therapy only in symptoms of Vataja Timir w.r.t Age Related Macular Degeneration (Dry Type).
|
follow up on 0th,7th,14th,21st,28th,42nd day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Abhijeet Tail Nasya,Viddhakarma and Antioxidant Therapy is not significantly effective than Antioxidant Therapy only in symptoms of Vataja Timir w.r.t Age Related Macular Degeneration (Dry Type). |
follow up on day 0th,7th,14th,21st,28th,42nd day |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/04/2025 |
| 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="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
Modification(s)
|
this is a randomized controlled clinical trial assessing the effectiveness of abhijeet tail nasya,viddhakarma and antioxidant with antioxidant therapy only given for 21 days in 72 patients. Patients will be observed for 42 days. the primary outcome is to see the effect of treatment on vataja timir (A.R.M.D) symptoms. secondary outcome is to see effect on visual acuity, amsler grid, Pelli Robson chart contrast sensitivity chart. |