| CTRI Number |
CTRI/2024/06/069323 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Ayurveda treatment and Correlation of personality trait with Eye problems
|
|
Scientific Title of Study
|
Correlation of Deha Prakriti & Refractive Errors with effect of Dosha Pratyanika Chikitsa in Respective Dosha predominant Prakriti
An Interventional study
|
| 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 Kadambari Solankure |
| Designation |
Associate Professor |
| Affiliation |
KLE Shri BMK Ayurved Mahavidyalay Belagavi |
| Address |
Department of Kriyasharir
KLE Shri BMK Mahavidyalaya Shahpur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9164503876 |
| Fax |
|
| Email |
ksolankure@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SuhasKumar Shetty |
| Designation |
Professor and Principal |
| Affiliation |
KLE Shri BMK Ayurved Mahavidyalay Belagavi |
| Address |
Department of Kayachikitsa
KLE Shri BMK Mahavidyalaya Shahpur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9164503876 |
| Fax |
|
| Email |
drsuhasshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SuhasKumar Shetty |
| Designation |
Professor and Principal |
| Affiliation |
KLE Shri BMK Ayurved Mahavidyalay Belagavi |
| Address |
Department of Kayachikitsa
KLE Shri BMK Mahavidyalaya Shahpur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9164503876 |
| Fax |
|
| Email |
drsuhasshetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Shri BMK Ayurveda Mahavidyalaya post graduate studies and Research Center Belagavi Karnataka India 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Kadambari Solankure |
| Address |
KLE Shri BMK Ayurved Mahavidyalay Belagavi |
| 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 Kadambari Solankure |
KLE Shri BMK Ayurved Mahavidyalaya and Post graduate studies and Research Center Belagavi |
Room Number 26
Department of Shalakyatantra
Belgaum
KARNATAKA |
9164503876
ksolankure@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Ethical Committie for Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H542||Low vision, both eyes. Ayurveda Condition: PRAKRUTIH, (2) ICD-10 Condition:H521||Myopia. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Erandmoola, Reference: : Acharya JT. Charaka Samhita Sutrasthana 25th Chapter -Yajja Purusheeya Adhyaya with Ayurveda Dipika commentary of Chakrapani Datta. Reprint ed. Varanasi (India): Chaukambha Orientalia; 2007. p.323, , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: -(2) Medicine Name: Yashtimadhu, Reference: : Acharya JT. Charaka Samhita Sutrasthana 25th Chapter -Yajja Purusheeya Adhyaya with Ayurveda Dipika commentary of Chakrapani Datta. Reprint ed. Varanasi (India): Chaukambha Orientalia; 2007. p.323, , Route: O, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of refractive errors with any duration
Subjects of Age group between 18 to 60 years
Irrespective of gender, occupation, religion and willing to participate in the study will be included
|
|
| ExclusionCriteria |
| Details |
Patients diagnosed with Cataract and other ophthalmic diseases
Patients with other known uncontrolled systemic ailments like Diabetes Mellitus Hypertension Tuberculosis etc
Patients suffering with congenital ophthalmic disorders, squint and various errors of refraction, trauma, Glaucoma, etc
Any kind of post-operative Ophthalmic and refractive errors cases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Refractive errors will be assesed by Distant vision NEAR vision and it will be Coorelated with Standard prakriti parikshana chart
|
baseline 30th day and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General Health will be assesed with short Questionaries comprising with 10 points |
Baseline 30th day 60th day |
|
|
Target Sample Size
|
Total Sample Size="993"
Sample Size from India="993"
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)
|
01/07/2024 |
| 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="4"
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
|
Many theories / hypothesis / conspiracies
/ predisposing factors are been postulated but exact scientific justification
for refractive errors yet to establish. Hence, an effort will be made to
evaluate the relation between specific Prakriti and Refractive
errors. Simultaneously intervend Dosha Pradhana Prakriti will be
treated with well-known Dosha Pratyanika drug. The effect of
given drugs over the best corrected vision will be assessed periodically as per
protocol. · Identification of incidence of Deha
Prakriti in cases of particular type of Refractive error.
· Effect of Doshapratyanika
chikitsa as per Pradhana Dosha Prakriti in particular type of
Refractive Errors.
·
The Deha Prakriti assessment will help Shalakyatantra
specialist to plan suitable treatment protocol suitable for particular Prakriti
in order to achieve maximum out come and reduce undue complications.
- For those health seekers who
are in search of knowing their Prakriti and planning their diet and
behavioural regimens to prevent undue complications of Refractive Errors.
Secondary Outcome Measures:
a. Changes in Vata
Pradhan Prakruti with particular type of Refractive Error, from
baseline i.e., 0th and at 30th & 60th days.
b. Changes in Pitta
Pradhan Prakruti with particular type of Refractive Error, from
baseline i.e., 0th and at 30th & 60th days.
c. Changes in Kapha
Pradhan Prakriti with particular type of Refractive Error, from
baseline i.e., 0th and at 30th & 60th days. |