| CTRI Number |
CTRI/2025/07/091256 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Jasakadi Rasayan in the management of early changes of diabetic retinopathy with the help of OCT(optical coherence tomography) machine. |
|
Scientific Title of Study
|
Clinical Study of Jasakadi Rasayan in the management of non-proliferative diabetic retinopathy with Optical Coherence Tomography (OCT) biomarkers as visual outcome predictors |
| 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 Aparna Prakash Bhoite |
| Designation |
PhD scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigadi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre Pradhikaran
Nigadi
Pune Maharashtra
411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9423585654 |
| Fax |
|
| Email |
aparnabhoite@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandana Abhay Virkar |
| Designation |
Professor and HOD Shalakyatantra |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigadi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre Pradhikaran
Nigadi
Pune Maharashtra
411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9822199107 |
| Fax |
|
| Email |
drvirkarchandana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Prakash Bhoite |
| Designation |
PhD scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigadi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre Pradhikaran
Nigadi
Pune Maharashtra
411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9423585654 |
| Fax |
|
| Email |
aparnabhoite@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aurved rugnalaya and Sterling multispeciality Hospital sector no 27 Pradhikaran Nigadi Pune, Maharashtra
India , 411044 |
|
|
Primary Sponsor
|
| Name |
Aparna Prakash Bhoite |
| Address |
PDEAs College of Ayurved and Research Centre Pradhikaran Nigadi Pune 411044 |
| 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 Aparna Prakash Bhoite |
Ayurved Rugnalay and Sterling multispecialty Hospital |
Sector no 27 Pradhikaran Nigadi Pune
Shalakya Department, Netra(ophthalmic) OPD, Room no 122
Pune
MAHARASHTRA |
9423585654
aparnabhoite@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee PDEAs college of Ayurveda and Research centre sector 25 Nigadi Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H350||Background retinopathy and retinalvascular changes. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Jasakadi Rasayan, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -Jasakadi Rasayan tablet contains Shuddha Jasad Bhasma, shuddha suvarna makshik bhasma, Triphla, Haridra,and Daruharidra |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with type 2 Diabetes
with or without visual disturbances, but with detectable ophthalmoscopic features of mild to moderate Non-proliferative Diabetic Retinopathy (such as exudates, hemorrhage, microaneurysm, cotton wool spots) |
|
| ExclusionCriteria |
| Details |
1 The patients with type 1 Diabetes or type 2 Diabetes taking insulin
2 Patients with recent cataract surgery within the previous 3 months
3 Hazy media for fundus evaluation
4 History of proliferative diabetic retinopathy (PDR) or other advanced eye diseases (retinal detachment, uveitis, Glaucoma, etc.).
5 Active uncontrolled systemic diseases
6 Pregnant or breastfeeding women
7 Participants in another clinical trial within the past 3 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in key OCT Biomarkers OR
BCVA(best corrected visual acuity) improvement of minimum 5 letters or more on the vision chart after treatment |
Duration of treatment- 3 months
Follow up at the end of 1 month and 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Jasakadi Rasayan on HbA1C levels with adjuvant conventional antidiabetic treatment |
Duration of treatment- 3 months
Follow up at the end of 1 month and 3 month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="0"
Days="0" |
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
|
TITLE- CLINICAL STUDY OF JASAKADI RASAYAN IN THE MANAGEMENT OF NON-PROLIFERATIVE DIABETIC RETINOPATHY WITH OPTICAL COHERENCE TOMOGRAPHY (OCT) BIOMARKERS AS VISUAL OUTCOME PREDICTORS
PRIMARY RESEARCH QUESTION-- Is Jasakadi Rasayan effective in the management of non-proliferative diabetic retinopathy, with improvement in key OCT biomarkers as visual outcome predictors?
SECONDARY RESEARCH QUESTION- Is Jasakadi Rasayan effective in lowering the HbA1c levels when administered as an adjunct therapy to standard care? Study Design Type - Prospective, single-arm clinical trial
INCLUSION CRITERIA- 1 Patients with type 2 Diabetes, with or without visual disturbances, but with detectable ophthalmoscopic features of mild to moderate Non-proliferative Diabetic Retinopathy (such as exudates, hemorrhage, microaneurysm, cotton wool spots)
2 Patients of either sex between 40 to 70 years old
EXCLUSION CRITERIA-
1 The patients with type 1 Diabetes or type 2 Diabetes taking insulin 2 Patients with recent cataract surgery within the previous 3 months 3 Hazy media for fundus evaluation 4 History of proliferative diabetic retinopathy (PDR) or other advanced eye diseases (retinal detachment, uveitis, Glaucoma, etc.). 5 Active uncontrolled systemic diseases 6 Pregnant or breastfeeding women 7 Participants in another clinical trial within the past 3 months
Sample size- Total 80 eyes
Trial Drug -- Jasakadi Rasayan Tablet ( It has Shuddha Jasad Bhasma, Shuddha Suvarna Makshik Bhasma, Triphala, Haridra, and Daruharidra)
Dose- Jasakadi Rasayan tablet 250 mg twice a day for 90 days
ROUTE OF ADMINISTRATION- Orally
Duration of treatment- 3 months (90 days)
FOLLOW-UPS- After 1 month and after 3 months
Variables to be studied from Digital Fundus Photography-- Microaneurysm, Cotton Wool Spots, Hard Exudates, and Retinal Hemorrhage
OCT Biomarkers to be studied --
1 Macular oedema (EDTRS Grid) 2 Disorganization of inner retinal layers (DRIL) 3 Hyper reflective Foci (HRF) 4 Intraretinal cystoid spaces(ICS) 5 Sub-foveal neuro-retinal detachment(SND) 6 Vitreomacular traction(VMT)
Results-- The result will be drawn based on the criteria of assessment and Statistical analysis.
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