| CTRI Number |
CTRI/2024/04/066061 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Bhringraj Yashtimadhu Siddha Taila Pratimarsh Nasya in Short-Sightedness |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study On Add-On Effect Of
Bhringaraj Yashtimadhu Siddha Taila Pratimarsh Nasya In 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 Shruti S Karade |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved |
| Address |
Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital Department of Shalakyatantra OPD No 26 Dhankawadi Campus Katraj Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9552730927 |
| Fax |
|
| Email |
shruti.karade-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Mulik |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved |
| Address |
Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital Department of Shalakyatantra OPD No 26 Dhankawadi Campus Katraj Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9823491389 |
| Fax |
|
| Email |
santosh.mulik@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh Mulik |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved |
| Address |
Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital Department of Shalakyatantra OPD No 26 Dhankawadi Campus Katraj Pune
MAHARASHTRA
411043
India |
| Phone |
9823491389 |
| Fax |
|
| Email |
santosh.mulik@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF SHALAKYATANTRA, College of Ayurved, Bharati Vidyapeeth (Deemed to be University), Katraj Dhankawadi Campus, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Shruti S Karade |
| Address |
DEPARTMENT OF SHALAKYATANTRA, College of Ayurved, Bharati Vidyapeeth (Deemed to be University), Katraj Dhankawadi Campus, Pune |
| 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 Shruti Karade |
Bharati Ayurved Hospital |
Bharati Vidyapeeth Deemed to be University, College of Ayurved and Hospital, Department of Shalakyatantra OPD No 26, Dhankawadi Campus, Katraj, Pune
Pune
MAHARASHTRA |
9552730927
shruti.karade-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR APPROVAL OF A RESEARCH PROJECT |
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 | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Charak Siddhi Sthana 9/12, Procedure details: Patient is advised to administer 2 drops of taila in each nostril, once a day in the morning)
(1) Medicine Name: Bhringaraj Yashtimadhu Siddha Taila, Reference: Bhaishajya Ratnavali Netrarog Chikitsa Adhyay, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 45 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Spectacles | Regular Use for 45 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between the age group of 18 to 40 years will be included.
2.Patients will be selected irrespective of gender, socioeconomic status and religion.
3.Patients diagnosed with Simple Myopia and having refractive power between -0.5D to -6.00D |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from high myopia and pathological myopia
2.Patients suffering from any retinal pathologies, ocular surface pathologies
3.Patients having congenital anomalies
4.One eyed patient |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement of visual acuity based on LOGMAR chart.
Reduction of refractive error in the trial group. |
Baseline, 15th, 30th, 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the symptoms of headache, eye strain and blurring of
vision in the trial group. |
Baseline, 15th, 30th, 45th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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
|
Myopia is the commonest type of refractive error affecting the general population globally. In myopia, parallel rays of light coming from infinity are focused in front of retina when accommodation is at rest and therefore, it is also referred to as ‘Short Sightedness’.In previous studies, no effective Ayurvedic treatment in Simple Myopia has been discovered yet. Also, Netra Tarpana and Abhyantar Sevana modalities have been used already. Bhringaraj is ‘Netrya’ and Yashtimadhu is ‘Chakshushya’ according to Ayurvedic texts and both of these, if given in Pratimarsh Nasya form can prove to be effective in Myopia. Pratimarsh Nasya does not vitiate any doshas.The study is being undertaken, after reviewing that Pratimarsh Nasya has never been used as a modality in treating Simple Myopia till date and it is cost effective as well. |