| CTRI Number |
CTRI/2025/02/081326 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Pasupath eye drop and Ushiradi Nasal drop in the management of shortsightedness. |
|
Scientific Title of Study
|
EFFECTIVENESS OF PASUPATHAVARTI ANJANA AND USHIRADI TAILA PRATHIMARSHA NASYA IN THE MANAGEMENT OF SIMPLE 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 |
Dr Keshav Vijay Kale |
| Designation |
PG Scholar Department of Shalakyatantra |
| Affiliation |
Government Ayurveda Medical College and Hospital Thiruvananthapuram |
| Address |
Department of Shalakya tantra Government Ayurveda Hospital Thiruvananthapuram Kerala, 695001.
Thiruvananthapuram
KERALA
695001
India |
| Phone |
07030239627 |
| Fax |
|
| Email |
kieshvkale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Keshav Vijay Kale |
| Designation |
PG Scholar Department of Shalakyatantra |
| Affiliation |
Government Ayurveda Medical College and Hospital Thiruvananthapuram |
| Address |
Department of Shalakya tantra Government Ayurveda College Thiruvananthapuram Kerala, 695001.
Thiruvananthapuram
KERALA
695001
India |
| Phone |
07030239627 |
| Fax |
|
| Email |
kieshvkale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sunilkumar |
| Designation |
Professor &HOD Department of Shalakyatantra |
| Affiliation |
Government Ayurveda Medical College and Hospital Thiruvananthapuram |
| Address |
Department of Shalakya tantra OP No :- 5 Government Ayurveda College Thiruvananthapuram Kerala 695001.
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946665110 |
| Fax |
|
| Email |
drsunilsalakya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital Thiruvananthapuram 695001 Kerala India |
|
|
Primary Sponsor
|
| Name |
Dr Keshav Vijay Kale |
| Address |
PG Scholar, Govt Ayurveda Medical college and Hospital, Thiruvananthapuram 695001 Kerala India |
| 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 Keshav Vijay Kale |
Government Ayurveda Medical Hospital Thiruvananthapuram |
Department of Shalakyatantra OP No 5 Government Ayurveda Hospital Thiruvananthapuram kerala 695001
Thiruvananthapuram
KERALA |
7030239627
Kieshvkale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE (IEC)Government Ayurveda College, Thiruvananthapuram Kerala India |
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 | Comparator Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: Sushruta Samhita Uttaratantra Dristigatroga chikitsa Adhyaya 17/41, Procedure details: Topical installation of tailam via Nasal r)
| | 2 | Intervention Arm | Procedure | - | rasakriyA, रसक्रिया | (Procedure Reference: Ashtang Hridaya Uttarasthana Sarvakshiroga Pratishedha Adhyaya , Procedure details: Topical Occular application (lower fornix))
|
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Patients will be selected irrespective of their gender, caste or religion.
Patients with Simple Myopia less than-3 dioptres power.
Patients between the age group 5 years to 25 years. |
|
| ExclusionCriteria |
| Details |
Myopia associated with other ocular pathologies of anterior and posterior segment of the eye affecting vision.
Patients Suffering from any systemic disorders.
Patients who have undergone any refractive surgeries.
Patients who are contraindicated for Anjana and Nasya |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate the Effectiveness of Pasupathavarti anjana and Ushiradi Taila Pratimarsha Nasya in reducing spectacle power. |
0th ,31st ,61st day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improving visual acuity in mild degree of simple Myopia. |
0th,31st,61st day |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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 3 |
|
Date of First Enrollment (India)
|
14/03/2025 |
| 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="6"
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
|
Developing a safe and effective medical intervention for myopia. Among the various treatment procedures indicated for Timira, the procedures Anjana and Pratimarsha Nasya are mentioned both as preventive and curative modalities and can be incorporated under daily regimen. Daily use of Anjana helps in improving sharpness of vision. Pratimarsha Nasya can be done in any age without any complications and on long term use, it has the same benefits of Marsha Nasya such as Indriyaprasada (Clarity of sense organs) and Akshapatava (improved functionality of sensory faculties). It is mentioned in Ayurvedic classics that Anjana after Nasya procedure acts as “Drikbalapradam”. Moreover, these procedures can be done in OP basis without the need for hospitalisation. Ushiradi Taila indicated in Drishtiroga Chikitsa in Susruta Samhita Uttaratantra possess Balya, Netrya, Rasayana, properties which may help in improving visual defects and Pasupathanjana mentioned in Sarvakshiroga Pratishedha in Astangahridaya Uttarasthana is mentioned as Dristiprasadana. In this study, Anjana karma with Pasupathvarti Anjana followed by Pratimarsha Nasya with Ushiradi Taila is selected for treating cases of simple myopia in the age group of 5 to 25 years. |