| CTRI Number |
CTRI/2026/02/103689 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
A comparative clinical study to evaluate the efficacy of krushnadya taila nasal drops along with retention of maha triphaladi ghee in eye and retention mahatriphaladi ghee in eye for distant vision |
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Scientific Title of Study
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An open label double arm randomized clinical comparative study to evaluate the efficacy of krushnadya taila nasya along with mahatriphaladi ghrita tarpana and mahatriphaladi ghrita tarpana in prathama patala gata timira w s r myopic astigmatism
|
| 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 Nagaraj s itagi |
| Designation |
Pg scholar |
| Affiliation |
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore |
| Address |
Opd no 21
Department of shalakya tantra sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore 10 pipeline road rpc layout vijayanagarbangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
7816017447 |
| Fax |
|
| Email |
drnagarajitagi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUJATAMMA K |
| Designation |
Professor |
| Affiliation |
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore |
| Address |
Opd no 21
Department of shalakya tantra sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore 10 pipeline road rpc layout vijayanagar bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
9448848786 |
| Fax |
|
| Email |
drsujathammaskamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUJATAMMA K |
| Designation |
Professor |
| Affiliation |
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore |
| Address |
Opd no 21
Department of shalakya tantra sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore 10 pipeline road rpc layout vijayanagar bangalore
KARNATAKA
560104
India |
| Phone |
9448848786 |
| Fax |
|
| Email |
drsujathammaskamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr nagaraj s itagi room number 21
department of shalakya tantra
Sri kalabyraveshwara swamy Ayurvedic college hospital and research center ,10 , pipeline rd, vijaynagar 2nd stage , hampi nagar, roc layout , vijaynagar , Banglore , India 560104
|
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Primary Sponsor
|
| Name |
Dr Nagraj S Itagi |
| Address |
Room Number 21
Department Of Shalakya Tantra Sri Kalabyraveswara Swamy Ayurvedic Medical College Hospital And Research Centre Banglore 10 Pipeline Road Rpc Layout Vijayanagar Bangalore
560104
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| Type of Sponsor |
Other [dr nagaraj] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr kiran m goud |
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre Bangalore |
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore, 10, pipeline road, r.p.c. layout, vijayanagar,bangalore
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCHRC |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: ashtanga hridaya, Procedure details: Nasya
Purva karmaPatient will be subjected to Mukha abhyanga with moorchita tila taila followed by sthanika sweda with ushna jala
Pradhana karma 8 drops of Krushnadya taila will be instilled into each nostril for 7 days
Paschat karma After nasya karma patient will be be given with luke warm salt water gargling
)
(1) Medicine Name: Krushnadya taila, Reference: chakradatta, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 7 Days |
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Inclusion Criteria
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| Age From |
10.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical features of Prathama patalagata Timira
Patients with clinical features of simple or compound Myopic Astigmatism.
Patient of either gender within the age group of 10-30 years.
Visual acuity up to 6/12 .
Patient of best corrected vision with cylindrical lens up to -1D with or without spherical -2D.
Patient who is fit for Nasya and Tarpana procedure.
|
|
| ExclusionCriteria |
| Details |
Patient with other ocular diseases like keratoconus, cataract, squint, glaucoma, retinal diseases
Patients with systemic conditions affecting the eye and secondary myopia e.g diabetes mellitus, connective tissue disorders.
Patient with history of ocular trauma or surgery
Pregenent women and lactating mothers .
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Method of Generating Random Sequence
|
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Method of Concealment
|
|
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Blinding/Masking
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Primary Outcome
|
| Outcome |
TimePoints |
To asceses the improvement in vision . Snellen’s chart
|
Total duration of study is 14 days nasya and tarpana for 7 days and follow up after 1 week |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
na |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/05/2026 |
| 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="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
In Ayurveda, Vataja Timira is known for producing symptoms such as avyakta darshana (difficulty in seeing distant objects) seen in myopic astigmatism. As Vata dosha is implicated in timira , therapies aimed at pacifying Vata are considered most appropriate. Snehana (oleation therapy) regarded as the primary treatment for this condition has been selected for this study. Ayurveda also describes effective procedures for Timira, including Virechana (purgation), Kriyakalpas (ocular procedures), and Nasya (nasal administration). Among these, Tarpana has been specifically highlighted in classical texts as a beneficial therapy for timira and enhancing visual function. The formulation Mahatriphaladi Ghrita, mentioned in Ashtanga Hridaya , is said to alleviate a wide range of ocular disorders when used as Tarpana.To enhance the therapeutic potential, Krushnadya Taila Nasya is selected . This formulation is mentioned in Chakradatta and also in Yogaratnakara, where it is described as highly effective in the treatment of Timira.
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