| CTRI Number |
CTRI/2025/01/078893 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Tiltailadi Nasya in comparison with Occlusion Therapy in the management of Anisometropic Amblyopia (Pratham patalgat Timir) |
|
Scientific Title of Study
|
Effect of Tiltailadi Nasya in the comparison with Occlusion Therapy in the management of Anisometropic Amblyopia w.s.r to Pratham patalgat Timir: Randomized Controlled 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 Kalyani Rajesh Dhawale |
| Designation |
PG scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya Nagpur |
| Address |
Opd No 11 Shalakyatantra Department Pakwasa
Samanwaya Rugnalaya Shri Ayurved Mahavidyalaya
Dhanwantari Marg Hanuman Nagar Nagpur
Maharashtra 440024 India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7972909861 |
| Fax |
|
| Email |
kalyanidhawale1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Govind Tundalwar |
| Designation |
HOD and associate Professor |
| Affiliation |
Shri Ayurved Mahavidyalaya Nagpur |
| Address |
Opd No 11 Shalakyatantra Department Pakwasa
Samanwaya Rugnalaya Shri Ayurved Mahavidyalaya
Dhanwantari Marg Hanuman Nagar Nagpur
Maharashtra 440024 India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9860166089 |
| Fax |
|
| Email |
drgovind2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalyani Rajesh Dhawale |
| Designation |
PG scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya Nagpur |
| Address |
Opd No 11 Shalakyatantra Department Pakwasa
Samanwaya Rugnalaya Shri Ayurved Mahavidyalaya
Dhanwantari Marg Hanuman Nagar Nagpur
Maharashtra 440024 India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7972909861 |
| Fax |
|
| Email |
kalyanidhawale1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ayurved Mahavidyalaya Dhanvantari Marg, Hanuman nagar Nagpur Maharashtra India pincode-440024 |
|
|
Primary Sponsor
|
| Name |
Dr Kalyani Rajesh Dhawale |
| Address |
Opd No 11 Shalakyatantra Department Pakwasa
Samanwaya Rugnalaya Shri Ayurved Mahavidyalaya
Dhanwantari Marg Hanuman Nagar Nagpur
Maharashtra 440024 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 Kalyani Rajesh Dhawale |
Shri Ayurved Mahavidyalaya Nagpur |
Opd No 11 Shalakyatantra Department Pakwasa
Samanvaya Rugnalaya Shri Ayurved Mahavidyalaya
Dhanwantari Marg Hanuman Nagar Nagpur
Maharashtra 440024 India
Nagpur
MAHARASHTRA |
7972909861
kalyanidhawale1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Commitee of Shri Ayurved Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H530||Amblyopia ex anopsia. Ayurveda Condition: PRATHAMA-PATALAGATADOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Occlusion Therapy | Occlusion Therapy with the help of occluder | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tiltail Nasya , Reference: Wagbhat , Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patient which shows symptoms of Anisometropic Amblyopia.
Patient age group 15-30 yrs.
Patient irrespective of sex, educational status, socio economic status, marital status, caste etc |
|
| ExclusionCriteria |
| Details |
Strabismic Amblyopia.
Toxic Amblyopia.
Idiopathic Amblyopia.
Organic Amblyopia.
Any ocular lesion |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Tiltailadi Nasya in comparison with Occlusion therapy
in the management of Anisometropic Amblyopia w.s.r to Pratham patalgat Timir |
At the end of 30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see effect of Tiltailadi Nasya in reduction of dioptric power by using lens. |
At the end of 30days |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
28/01/2025 |
| 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 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
|
consecutive samples of 44patients who are seeking treatment and care at the study hospital, who fulfil the eligibility (inclusion and exclusion) criteria and who consent to participant will be selected by convenience sampling method from the study setting (ie. the OPD/Ward/Hospital..). Thesample will be then randomly and equally allocated to two groups. The selected sample of 44 subjects will be randomly allocated to two groups using Simple block randomization method. A predetermined, computer generated random allocation plan will be utilised where in 11blocks of size 4 each will be used for equal assignment of subjects in to two comparison groups.First group will recieve tiltailadi nasya and second group will receive occlusion therapy
|