| CTRI Number |
CTRI/2023/03/050822 [Registered on: 17/03/2023] Trial Registered Prospectively |
| Last Modified On: |
08/03/2023 |
| 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
|
Clinical study to Evaluate the efficacy of Triphaladhyaghrita Pratimarsha Nasya in Simple Myopia |
|
Scientific Title of Study
|
Randomized Control Clinical Study To Evaluate The Efficacy of Triphaladhyaghrita Pratimarsh Nasya in Simple Myopia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Gajanan Belgaonkar |
| Designation |
PhD Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Seth Tarachand Ramanath Ayurvedic Charitable Hospital Rastha peth pune
Shalakyatantra netra opd no 14
first floor
Seth Tarachand Ramanath Ayurvedic Charitable Hospital Rastha peth pune
Shalakyatantra netra opd no 14
first floor
Pune
MAHARASHTRA
411011
India |
| Phone |
8605657046 |
| Fax |
|
| Email |
dr.poonam2785@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta S Salvi |
| Designation |
Professor and HOD |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Tilak Ayurved Mahavidyalaya Rastha peth pune 11
Tilak Ayurved Mahavidyalaya Rastha peth pune 11
Pune
MAHARASHTRA
411011
India |
| Phone |
09822082795 |
| Fax |
|
| Email |
salvisangeeta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Gajanan Belgaonkar |
| Designation |
PhD student |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Seth Tarachand Ramanath Ayurvedic Charitable Hospital Rastha Peth Pune
shalakyatantra netra opd no 14 first floor
Seth Tarachand Ramanath Ayurvedic Charitable Hospital Rastha Peth Pune
shalakyatantra netra opd no 14 first floor
Pune
MAHARASHTRA
411011
India |
| Phone |
8605657046 |
| Fax |
|
| Email |
dr.poonam2785@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Poonam Gajanan Belgaonkar |
| Address |
Plot No1 HallLaxmi nagar Garde nagar Gadhinglaj Dist Kolhapur |
| 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 |
| DrPOONAM GAJANAN BELGAONKAR |
Seth Tarachand Ramanath Charitable Ayurvedic hospitl |
Shalakyatantra Netraroga department OPD NO 14 First floor
Pune
MAHARASHTRA |
8605657046
dr.poonam2785@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tilak Ayurved Mahavidyalaya Pune |
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 | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: sushrutsamhita, Procedure details: Patient is asked to lie down in supine position & neck low position
For adult instill two drops of triphaladhyaghrita & for children instill one drop in each nostril
Pinch the nose once & after releasing suck the ghrita up
Patient is asked to spit the ghrita when it reaches throat
)
(1) Medicine Name: Triphaladhyaghrita, Reference: sharangdharsamhita, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: bd, Duration: 90 Days | | 2 | Comparator Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: sushrutsamhita, Procedure details:
Patient is asked to lie down in supine position & neck low position
For adult instill two drops of Abhijeet taila & for children instill one drop in each nostril
Pinch the nose once & after releasing suck the taila up
Patient is asked to spit the taila when it reaches throat
)
(1) Medicine Name: Abhijeettaila, Reference: Bhaishajyaratnawali, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Duration: 90 Days |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
patients of simple myopia with low error less than or equal to minus 3D with normal opthalmoscopic findings |
|
| ExclusionCriteria |
| Details |
patients of moderate myopia minus 3D to minus 6D
Patients of High myopia greater than or equal to minus 6D
Keratometry Reading less than 40D And greater than 45D
Compound myopia and astigmatism excluded
axial length greater than 28 excluded
patient with other ocular pathology involving glaucoma cataract retinopathy corneal ulcer conjunctivitis uveitis excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy of Triphaladhyaghrita pratimarsha nasya in simple myopia |
90days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse Reaction if any |
90days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
25/04/2023 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is single blind randomized controlled clinical study to evaluate the efficacy of Triphaladhya ghrita pratimarsha nasya in simple myopia. Total 200 patients of age 8 to 30 years of both sex will be randomly selected for this trial and divided in to two groups. Group A Treated with Triphaladhya ghrita pratimarsha nasya Adult dose (16 to 30 years) two drops in each nostril morning and evening for 90 days. Child dose (8 to 15 years) One drop is each nostril morning and evening for 90 days. Group B – Treated with Abhijeet Taila Pratimarsha Nasya Adult dose (16 to 30 years) two drops in each nostril morning and evening for 90 days. Child dose (8 to 15 years) One drop is each nostril morning and evening for 90 days. Data will be analysed and appropriate statistical tests will be applied.
|