| CTRI Number |
CTRI/2024/02/062413 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of Nayanrogahari Varti Anjana and Vimala Varti Anjana in the management of Timira with special reference to simple Myopia |
|
Scientific Title of Study
|
A comparative clinical study of Nayanrogahari varti Anjana and Vimala varti Anjana in the management of Timira w.s.r. to 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 |
DINESH GURJAR |
| Designation |
P.G. Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital And Research Centre |
| Address |
Department Of Shalakya Tantra, First Floor Room Number 1 Mansarovar Ayurvedic Medical College Hospital And Research Centre Hinotiya Alam Kolar Road Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9827634702 |
| Fax |
|
| Email |
dineshgurjar100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Arunima Namdeo |
| Designation |
Professor and Head Of Department |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital And Research Centre |
| Address |
Department Of Shalakya Tantra, First Floor Room Number 1 Mansarovar Ayurvedic Medical College Hospital And Research Centre Hinotiya Alam Kolar Road Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9179832716 |
| Fax |
|
| Email |
arunimasyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DINESH GURJAR |
| Designation |
P.G. Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital And Research Centre |
| Address |
Department Of Shalakya Tantra, First Floor Room Number 1 Mansarovar Ayurvedic Medical College Hospital And Research Centre Hinotiya Alam Kolar Road Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9827634702 |
| Fax |
|
| Email |
dineshgurjar100@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar Ayurvedic Medical college hospital and research centre bhopal |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College Hospital And Research Centre |
| Address |
Department Of Shalakya Tantra, First Floor Room Number 1 Mansarovar Ayurvedic Medical College Hospital And Research Centre Hinotiya Alam Kolar Road Bhopal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 DINESH GURJAR |
Mansarovar Ayurvedic Medical College Hospital and Research centre |
Department Of Shalakya Tantra, First Floor Room Number 1 Hinotiya Alam Kolar Road Bhopal
Bhopal
MADHYA PRADESH |
9827634702
dineshgurjar100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mansarovar ayurvedic medical College Hospital And Research centre Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH, (2) ICD-10 Condition:H538||Other visual disturbances. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | guTikA~jjanam, गà¥à¤Ÿà¤¿à¤•à¤¾à¤½à¤œà¥à¤œà¤¨à¤®à¥ | (Procedure Reference: Sushrut samhita , Procedure details: Anjana karma once a day at morning )
(1) Medicine Name: Vimala varti , Reference: Ashtanga hriday , Route: Topical, Dosage Form: Varti/ Suppository, Dose: 00(NA), Frequency: od, Duration: 28 Days | | 2 | Intervention Arm | Procedure | - | guTikA~jjanam, गà¥à¤Ÿà¤¿à¤•à¤¾à¤½à¤œà¥à¤œà¤¨à¤®à¥ | (Procedure Reference: Sushrut samhita , Procedure details: Anjana karma once a day at morning )
(1) Medicine Name: Nayanrogahari varti , Reference: Ras Ratna Sammuchay , Route: Topical, Dosage Form: Varti/ Suppository, Dose: 00(NA), Frequency: od, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with Timira and simple myopia will be selected for the study.
2. Patients having signs and symptoms of Timira and simple myopia up to -3D refractive power within the age group of 13-40 years with normal fundus.
|
|
| ExclusionCriteria |
| Details |
1. Patients having myopic degenerative changes and having more than -3D refractive power.
2. Patients having any other known ocular pathology ex. cataract corneal opacity iridocyclitis Glaucoma other Retinal diseases etc.
3. Patients suffering from any systemic diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare effect of Nayanrogahari Varti Anjana and Vimala Varti Anjana in the management of Timira wsr to simple myopia |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study detail about timira & simple myopia
to study mode of action of nayanrogahari varti anjana & vimala varti anjana |
6 weeks |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/02/2024 |
| 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 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
|
Myopia is one of the most prevalent disorders of the
eye. It causes visual impairment in both children and adults. The prevalence of
myopia is nearly 22% of the world population and 21.15% in Indian population .
This number is expected to be rise because of more use of electronic devices
e.g. smart phone and computer. The growing incidence of myopia is related to
changes in children’s behavior, especially how little time they spend outdoors,
often staring at screens indoors instead of enjoying activities illuminated by
daylight. Optical aids such as eye glasses and contact lenses, are used to
correct the errors but not permanently cure it, instead it create a lot of
inconveniences in daily life. Surgical measures like RK(Radial Keratomy), PRK (Photorefractive
Keratoplasty), LASIK (Laser assisted stromal in situ keratomileasis), ICR
(Intra corneal ring) all carry the risks and complications apart from being
expensive. No works have been done
regarding Nayanrogahari Varti Anjana in
the management of Timira w.s.r.
to simple myopia. So the present study has been selected.
|