| CTRI Number |
CTRI/2024/11/077291 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study on Isotine CD eye drop and capsule Iso DR in diabetic retinopathy |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of Isotine CD eye drop and capsule Iso DR in Subjects Suffering from Non proliferative Diabetic Retinopathy NPDR A randomized, Open labeled, multi-center, comparative, interventional, prospective, clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ISOCD/DR/JAGAT/2024/1, Version 1.0, 06th Sept 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushpalata D Ingale |
| Designation |
Assistant Professor (Shalakya Tantra) |
| Affiliation |
Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Nashik |
| Address |
Department of Shalakya Tantra OPD No 5, Ground Floor,
Ayurved Seva Sanghs, Ayurved Mahavidyalaya,
Ganeshwadi, Panchavati, Nashik, MAHARASHTRA
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
8208780841 |
| Fax |
|
| Email |
pdingaledr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai 400064
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai 400064
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jagat Pharma Pvt. Ltd
No- 23 B, Stadium Rd,
Model Town, Bareilly, Uttar Pradesh 243122 |
|
|
Primary Sponsor
|
| Name |
Jagat Pharma Pvt. Ltd |
| Address |
No- 23 B, Stadium Rd,
Model Town, Bareilly, Uttar Pradesh 243122
|
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pushpalata D Ingale |
Ayurved Seva Sanghs, Ayurved Mahavidyalaya |
Department of Shalakya Tantra OPD No 5, Ground Floor,
Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Ganeshwadi, Panchavati, Nashik, MAHARASHTRA 422003 India
Nashik
MAHARASHTRA |
8208780841
pdingaledr@gmail.com |
| Dr Prabhakar Vardhan |
National Institute of Ayurveda |
OPD No 14, Ground Floor, Department of Shalakya Tantra, National Institute of Ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan, 302002
Jaipur
RAJASTHAN |
9461065960
prabhakar.salakya@nia.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ayurved Seva Sanghs, Ayurved Mahavidyalaya Nashik |
Approved |
| Institutional Ethics Committee, National Institute of Ayurveda, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E113||Type 2 diabetes mellitus with ophthalmic complications. Ayurveda Condition: DRUSHTIGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Isotine CD eye drop and capsule Iso DR, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Samudga, Duration: 180 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard of care | Subjects in Standard treatment group will be given standard of care for a period of 6 months. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects diagnosed with type 1 and 2 diabetes mellitus.
2. Subjects diagnosed with mild to moderate cases of non-proliferative diabetic retinopathy, in whom pan retinal photocoagulation is not imminently required in the ophthalmologist’s judgment.
3. Best corrected ETDRS VA in study eye greater than 49 letters
4. HbA1C less than 8 percent
5. Able and willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
1. Complicating severe vitreous haemorrhage, or requiring laser and vitrectomy treatment.
2. Subjects who have received Retina laser photocoagulation.
3. Subjects whose dioptric media is so turbid that hard to evaluate the fundus picture.
4. Retinal conditions which may mask assessment e.g. retinal vein occlusion
5. Systolic blood pressure greater than 180 mm of Hg or diastolic blood pressure greater than 110 mm of Hg
6. History of major ocular surgery (scleral buckle, any intraocular surgery etc. in the study eye within prior 6 months
7. DMKA or other acute metabolic disturbance, or complicating severe acute infection within a month from screening visit.
8. History of systemic corticosteroids within 3 months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 3 times per week.
9. Previous treatment with intravitreal or sub tennon triamcinilone within the past 3 months in the study eye.
10. Previous participation in any studies of investigational drugs within 1- month preceding day 0 (excluding vitamins and minerals)
11. Subject with other severe Diabetic complications.
12. Having known allergic reaction to ingredients of Isotine CD eye Drops and capsule Iso DR
13. Pregnant or breast feeding.
14. Subjects with glaucoma, uveitis, ocular neuropathy and severe cataract etc.
15. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative change in retinal micro-hemorrhages and macular edema as assessed by fundoscopy |
Screening Visit (up to Day 5 days), Baseline Visit (Day 0), Visit 1 (Day 90), Visit 2 (Day 180) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1). Comparative change in retinal soft and hard exudates and microaneurysms as assessed by fundoscopy
2). Comparative change in Visual acuity
3). Comparative change in ETDRS-DRSS scale
4). Global assessment for overall change by investigator and subject
5). Assessment of tolerability of study drugs by investigator and subject
6). Assessment of adverse events
|
Screening Visit (up to Day 5 days), Baseline Visit (Day 0), Visit 1 (Day 90), Visit 2 (Day 180) |
|
|
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)
|
09/12/2024 |
| 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) |
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
|
It is a clinical study to evaluate of efficacy and safety of Isotine CD eye
drop and capsule Iso DR in subjects suffering from Non proliferative Diabetic
Retinopathy (NPDR). The clinical study will be conducted at 4 to 5 centres in
India. As per computer generated randomization list, subjects will be
randomized either to Isotine CD eye drop and capsule Iso DR group or standard
treatment group in 1: 1 ratio. Subjects in Isotine CD eye drop and capsule Iso
DR group will be asked to put given medication (Isotine CD eye drop) in a dose
of 1 drop in each eye 4-5 times daily and capsule Iso DR in a dose of 1 capsule
twice daily orally after meals with water for a period of 6 months. Subjects in
the standard treatment group will be given standard of care for a period of 6
months. The primary objective of the study will
be to assess comparative change in retinal micro-hemorrhages
and macular edema as assessed by fundoscopy. The secondary objectives of the
study will be to assess comparative change in
retinal soft and hard exudates and microaneurysms as assessed by fundoscopy, comparative
change in Visual acuity, comparative change in ETDRS-DRSS scale, global
assessment for overall change by investigator and subject, assessment of
tolerability of study drugs by investigator and subject and adverse events on screening
Visit (up to Day 5 days), Baseline Visit (Day 0), Visit 1 (Day 90), Visit 2
(Day 180) |