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CTRI Number  CTRI/2024/03/064454 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 09/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic drug trial on Diabetic Retinopathy 
Scientific Title of Study   Single arm pilot clinical trial to evaluate the efficacy of Ayurvedic treatment on Diabetic Macular Edema 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vijina Ravindran 
Designation  Junior Resident 
Affiliation  Banaras Hindu University 
Address  Room no 13 Shalakya Tantra OPD Indian medicine wing Sir Sunderlal Hospital Institute of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9400356398  
Fax    
Email  binnamr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Professor Manoj Kumar 
Designation  Professor and Head of Department 
Affiliation  Banaras Hindu University 
Address  Room no 13 Shalakya Tantra OPD Indian medicine wing Sir Sunderlal hospital Institute of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9793127744  
Fax    
Email  mkumarbhu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vijina Ravindran 
Designation  Junior Resident 
Affiliation  Banaras Hindu University 
Address  Room no 13 Shalakya Tantra OPD Indian medicine wing Sir Sunderlal hospital Institute of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9400356398  
Fax    
Email  binnamr@gmail.com  
 
Source of Monetary or Material Support  
Institute of Medical Sciences Banaras Hindu University Varanasi 221005 Uttarpradesh  
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijina Ravindran  Sir Sunderlal Hospital  Room no 13 Shalakya Tantra OPD Department of Shalakya Tantra Indian medicine wing Institute of Medical Sciences Banaras Hindu University Varanasi 221005
Varanasi
UTTAR PRADESH 		 9400356398

binnamr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Institute of Medical sciences, Banaras Hindu University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H358||Other specified retinal disorders. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Punarnavadi Kashaya, Reference: Bhaishajya Ratnavali chapter no 42 slogam number 13, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Dasamoola Hareetali leha, Reference: Ashtanga Hridaya Chikitsasthana chapter number 17 slogam number 15-16, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Nishi
(3) Medicine Name: Madhuyashtyadi taila, Reference: Ashtanga Hridaya Chikitsasthana Chapter number 22 slogam number 41-44, Route: Oral, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: 1 hour after food
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient who consent for study
Study eye having CI-DME as confirmed on OCT.
Patients with best corrected ETDRS visual acuity score of at least 79 (Snellen
equivalent of 20/25).
Patients who decline both intravitreous therapy and laser photocoagulation and
willing to take study group medication.
Patients with good glycemic control by diet control, lifestyle modifications or
systemic hypoglycemic drugs.
Only one eye of participant to be included. The eye with worse BCVA will be
included in the study. In case both eyes have equal best corrected visual acuity the
right eye will be considered for study.
Non-pregnant women. 
 
ExclusionCriteria 
Details  Patient with diabetic macular edema with proliferative diabetic retinopathy
Patients treated with focal/grid laser within 6 month, intravitreal Anti-VEGF injections within 3 month and intravitreal steroid within 6 months of study entry, history of
intraocular surgery within 90 days before study entry.
Patients with unstable medical status including blood pressure and glycemic control
Patients in poor glycemic control who recently initiated intensive insulin treatment (a
pump or multiple daily injections) or plan to do so in the next 6 months.
Macular edema is not considered to be due to a cause other than diabetic macular edema. An eye should not be considered eligible (i) if the macular edema is considered to be related to cataract extraction or (ii) clinical examination and/or OCT suggests that vitreoretinal interface disease (e.g. vitreo-retinal traction or epiretinal membrane) is the
primary cause of the macular edema.
Ocular condition (other than diabetes) that might affect macular edema or alter visual
acuity (e.g. vein occlusion, uveitis or other ocular inflammatory disease, neovascular
glaucoma, Irvine- Gass Syndrome). Glaucoma per se is not an exclusion.
An ocular condition is present such that, visual acuity would not improve from resolution of macular edema (e.g. foveal atrophy, pigmentary changes, dense sub-foveal
hard exudates, non- retinal condition).
Patients with a history of acute coronary event or stroke, renal failure, pregnancy or
lactation.
Media clarity, pupillary dilation, and patient cooperation insufficient for adequate
fundus and OCT examination.
If patient decides to leave the trial to undergo intravitreous standard therapy. 

Any adverse effect observed.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean change in Central Subfield Thickness (CST)
 		 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in best corrected viaual acuity (BCVA)
Mean change in Central Retinal Thickness (CRT) and Maximum Macular Thickness (MMT)  		 3 months. 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   01/04/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Diabetic macular edema (DME) is one of the leading causes of vision loss worldwide. DME is a condition characterised by thickening and swelling of macula caused by microvascular leakage which can occur in any stage of Diabetic Retinopathy.  Intravitreal drug injections are the main therapy for DME. They carry the risk of intraocular damage and represent an enormous economic burden for patients. This study will be conducted on known case of T2DM having CI-DME as confirmed on OCT. Subjects will be given Punarnavadi kashaya  in a dose of 10 ml BD mixed in 40ml of warm water half an hour before meals, Dasamoola Hareetaki Lehya orally in a dose of 10gm HS, Madhuyashtyadi Taila orally in a dose of 5ml BD with warm water 1 hour after meals. ETDRS visual acuity, OCT measured Central Subfield Thickness (CST) and Central Retinal Thickness (CRT) and Maximum Macular Thickness (MMT) will be assessed and compared with baseline after 3 months. 
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