| CTRI Number |
CTRI/2025/01/079368 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
30/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic Management of Shortsightedness |
|
Scientific Title of Study
|
Comparative Study of Triphaladi Rasayan and Dhatriyadi Rasakriyanjan in Treatment of Blurring of distance vision due to Simple Myopia an Open lable Randomized Controlled Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Renu P Raokhande |
| Designation |
PhD scholar |
| Affiliation |
Bhargava Ayurved Collage |
| Address |
Department of Shalakya Tantra,Room no 11 , Bhargava Ayurved Collage R H Patel Technical Campus Vidyagram Dahemi Borsad Gujarat
Anand
GUJARAT
388350
India |
| Phone |
9588474824 |
| Fax |
|
| Email |
work9869@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF Dr Ganga R Hadimani |
| Designation |
Professor |
| Affiliation |
J S Ayurveda Mahavidyalaya |
| Address |
Department of Shalakyatantra J S Ayurveda Mahavidyalaya collage Road Nadiad Kheda Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
8780067570 |
| Fax |
|
| Email |
gangupatil2001@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renu P Raokhande |
| Designation |
PhD scholar Associate Professor |
| Affiliation |
Bhargava Ayurved Collage |
| Address |
Department of Shalakyatantra Room no 11 Bhargava Ayurved Collage R H Patel Technical Campus Vidyagram Dahemi Borsad
Kheda
GUJARAT
388350
India |
| Phone |
9588474824 |
| Fax |
|
| Email |
work9869@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhargava Ayurved Pharmacy Bhargava Ayurveda College R H Patel Campus Dahemi Anand 388350 Gujrath. |
|
|
Primary Sponsor
|
| Name |
Dr Renu Raokhande |
| Address |
Bhargava Ayurved Collage R H Patel Campus Vidhyagram Dahemi Ta Borsad Gujarat 388350 |
| 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 Renu Raokhande |
Bhargava Ayurved Hospital |
Department of Shalakya Tantra Room No 11 Bhargava Ayurved Hospital R H Patel Tecnical Campus Vidhyagram Dahemi Borsad 388350
Anand
GUJARAT |
9869827830
work9869@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maganbhai Adenwala Mahagujarat University Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) 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: Triphaladi Rasayana, Reference: Abhinava Chinthamani, Route: Oral, Dosage Form: Churna/ Powder, Dose: 8(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu and Ghritha), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhatriyadi Rasakriya anjana, Reference: Bhaishajya Ratnavali, Route: Ocular, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphaladi Rasayana, Reference: Abhinav Chinthamani, Route: Oral, Dosage Form: Churna/ Powder, Dose: 8(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu and Ghritha), Additional Information: -(2) Medicine Name: Dhatryadi rasakriyanjana, Reference: Bhaishajya Ratnavali, Route: Ocular, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with Simple Myopia with complains of Blurness of vision eyestrain headache epiphora will taking for trial AS PER MODERN PARAMETER |
|
| ExclusionCriteria |
| Details |
Patient other than Myopia symptoms will excluded SYSTEMIC DISEASES LIKE DIABETES HYPERTENSION RENAL DISEASES GLAUCOMA ANY CORNEAL PATHOLOGY |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CHANGES IN SIMPLE MYOPIC SYMPTOMS ( blurness of vision epiphora headache eyestrain |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Myopic symptoms like Blurness of vision epiphora eyestrain headache |
2 months |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
07/02/2025 |
| 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="2"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Myopia is most commonly prevalent in people in young children and adults As per prevelence rate The epidemiology studies conducted by American Academy of Ophthalmology shows that Myopia is not a simple refractive error but an eyesight threatening diseases In east asia myopia has become the most common cause of blindness in young people with a prevelence rate of 80 persent to 90 present Myopia can lead to comorbidities that significantly increase the risk of severe and irreversible vision loss including example like retinal detachment subretinal neovascularization dense cataract and glaucoma
Triphaladi Rasayan and Dhatriyadi Rasakriyanjan is selected for the protocol because of Netraya Rasayana Timira nashaka Chakshushya property
Patient will be assessed based on symptoms of simple myopia in symptoms of blurness of vision epiphora headache eyestrain
Assesment will be done based on special proforma through pattern and will be analyzed statically with the help of Friedman test in subjective parameter Wilcoxon statistical test will be used to assess the impact on objective parameter and ANOVA test will be used for comparative analysis between the three groups where p is >0.05 = in significant result p is < 0.05 = significant result and p is <0.001= highly significant result |