| CTRI Number |
CTRI/2025/03/082888 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Usheeradi Taila Nasya and Usheeradi Anjana in cases of Myopia |
|
Scientific Title of Study
|
Clinical evaluation of Usheeradi Taila Nasya and Usheeradi Anjana in the management of Prathama Patala Gata Timira with special reference to Myopia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonali Mahadev Sanadi |
| Designation |
MS Scholar |
| Affiliation |
Institue of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Shalakya Tantra ,Fourth Floor,Institute building,ITRA jamnagar,opp.B. Division Police Station,Gurudwara Road,Jamnagar,Gujarat
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9325837037 |
| Fax |
|
| Email |
sanadisonali9@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Deepak Pawar |
| Designation |
Associate professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Shalakya Tantra,Fourth Floor,Institute building,ITRA Jamnagar,Opp.B. Division Police station,Gurudwara Road,Jamnagar,Gujarat
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
7737379173 |
| Fax |
|
| Email |
drpawar29@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sonali Mahadev Sanadi |
| Designation |
MS Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Shalakya Tantra,Fourth Floor,Institute building,ITRA Jamnagar,Opp.B.Division Police station,Gurudwara Road,Jamnagar,Gujarat
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9325837037 |
| Fax |
|
| Email |
sanadisonali9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda Jamnagar,Opp.B.Division Police Station,Gurudwara road,Jamnagar,Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Institue of Teaching and Research in Ayurveda |
| Address |
Department of Shalakya Tantra,Fourth floor,Institute building,ITRA Jamnagar Opp.B.Division Police station,Gurudwara road
Jamnagar,Gujarat 361008 |
| 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 Sonali Mahadev Sanadi |
Institute of Teaching and Research in Ayurveda Jamnagar |
O.P.D No. A-2 EYE OPD of Shalakya Tantra, Institute of Teaching and Research in Ayurveda Jamnagar,Opp.B.Division Police station,Gurudwara Road,Jamnagar,Gujarat
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT |
9325837037
sanadisonali9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Institute of Teaching and Research in Ayurveda Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chitrakadi Gutika, Reference: Charak Chikitsa Ch.15 Ver. 97, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eranda Bhrushta Haritaki, Reference: Brihat Nighantu Ratnakar Shleepada Chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 3 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Sushrut Uttartantra Vol.1 Ch.40, Procedure details: The patient will be asked to lie in supine position extending his/her arms and legs and head slightly extended upto 45 degree. Later tip of nose will be drawn upward by left index finger and with right hand the lukewarm medicament will instilled into both nostrils using pichu or dropper or index finger.)
(1) Medicine Name: Usheeradi Taila, Reference: Sushrut Uttartantra Ch.17 Ver.41, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 7 Days | | 4 | Intervention Arm | Procedure | - | a~jjanam, अंजनम् | (Procedure Reference: Sushrut samhita Ch.18 Ver.64-65 , Procedure details: Advice patient to sit on chair. Clean the eyes with wet cotton. Take the proper amount of Usheeradi Anjana over the Shalaka. Retract the lower lid and apply the Usheeradi Anjana into lower fornix from the inner canthus to the outer canthus. Close the eye and let the tears come out. When the lacrimation stops wash the eyes with distilled water and clean fornix with clean cotton.)
(1) Medicine Name: Usheeradi Anajana, Reference: Ashtang Hridyam Uttartantra Ch.13 Ver.76-77, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 30(mg), Frequency: od, Duration: 30 Days | | 5 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saptamruta Lauha, Reference: Bhaisjyaratnavali Netrarog Chikitsa Ver. 53-54, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Madhu and Ghrita in unequal proportion), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients complaining Avyakta Darshana/Indistinct distance vision.
2.Patients having a less than -6.00 dioptre will be selected for the present clinical trial.
3.Patients aged between 18 to 35 years. |
|
| ExclusionCriteria |
| Details |
1.patients having any other ocular pathology,e.g. cataract, corneal opacity, iridocyclitis, red eye, retinal diseases, Dwitiya, Tritiya and Chaturtha Patalagata Timira will be excluded.
2.Patients suffering from acute rhinitis, chronic debilitating conditions, recurrent fever, recurrent headaches, hypertension, meningitis, increased intracranial pressure will be excluded.
3.Alcoholic patients, pregnant women will also be excluded.
4.Patients aged below 18 and above 35 years will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of treatment protocol on sign and symptoms of Prathama Patalagata Timira w.s.r.t of Myopia or changes in the unaided distance visual acuity. |
During the treatment period of 52 days.and follow up of 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in subjective criteria.
2. Changes in axial length and K1, K2 values.
3.Changes in correction for myopia. |
During the treatment period of 52 days.and follow up of 30 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)
|
01/05/2025 |
| 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
|
Purpose of the research: Simple Myopia can be corrected with spectacle or contact
lenses.Surgical treatment (LASIK etc) of Myopia is also becoming popular now a days but,these
method for Myopic correction are not without complications besides being costly and out of
reach of general population and also do not prevent myopic progression In Ayurveda many
formulations are advocated for Timira for enhancement of vision Hence ,Usheeradi Nasya and
Usheeradi Anjana in Prathama Patalagata Timira w.s.r.to Myopia which include ,Deepana
Pachana along with Koshtashuddhi proceeding the procedures of Nasya and Anjana are selected
in this study Therefore patients suffering from Myopia a clinical study has been planned entitled -Clinical evaluation of Usheeradi Taila Nasya and Usheeradi Anjana in the management of
Prathama Patalagata Timira w.s.r.to Myopia-An open labelled single arm clinical trial
Information on the Trial procedure and Drug: Study Group – Single arm study group
,Deepana -Pachana by Chitrakadi Gutika 1BD 250 mg with lukewarm water after food for 7
days .Koshtashuddhi by Eranda Bhrushta Haritaki Churna 5 gms at night with lukewarm water
before food for 7days .After Deepana -Pachana and Koshtashuddhi Usheeradi Taila Nasya will
be given for 7 days (Marsha Nasya )6 Bindu in each nostril .After one day gap of Nasya,
Usheeradi Anjana will be given for one month in Rasakriya form in 1 Vellaja dose .Along with
Anjana, Chakshushya drug Saptamruta Lauha will be given for one month 250 mg in Vati form
orally . We assure that we will prepare formulations as per S.O.P in the pharmacy of I.T.R.A.
Description of the Process: In present study, participants who will be clinically diagnosed and
confirmed cases of Prathama Patalagata Timira (Myopia) enlisted in inclusion criteria will be
enrolled. The study include single group of 30 patients with sign and symptoms of Prathama
Patalagata Timira (Myopia) which is an open labelled clinical trial.
Follow-up: After completion of the treatment, the patient will be followed up for 1 month at
the interval of 15 days.
Side Effects: We will follow closely and keep track of any unwanted effects. We may use
some other medicines or stop the usage of drug to decrease the symptoms of the side effects.
Results: The efficacy of the therapy will be assessed on the basis of subjective and objective
criteria.
Benefits: Project will help us to resolve the research question. There may not be any benefit for
the society at this stage of the research, but future generations are likely to be benefited as to
find out proper treatment protocol for the management of Prathama Patalagata Timira
(Myopia). Collected information from this research project will be kept confidential, all
outcomes will be noted in tabular form and appropriate statistical tests will be applied to compare the effect. |