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CTRI Number  CTRI/2024/04/065524 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 08/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Study on the effect of ayurvedic medicine and therapy in diabetic retinopathy  
Scientific Title of Study   A clinical study on the effect of patolyadi ghrita akshitarpana & shilajit rasayana in diabetic retinopathy  
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 Sreeharsha Vedantham 
Designation  Post graduate 
Affiliation  Dr BRKR government Ayurvedic medical college 
Address  room no 11 OPD, Dept of shalakya Government Ayurvedic hospital SR nagar Hyderabad Telangana
Dept of shalakya Dr.BRKR Government Ayurvedic medical college SR nagar Hyderabad Telangana
Hyderabad
TELANGANA
500038
India 
Phone  7207998633  
Fax    
Email  sreeharshavedantham@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anasuya K 
Designation  Principal and HOD Dept of shalakya Dr BRKR GAC 
Affiliation  Dr BRKR Government Ayurvedic Medical college 
Address  room no 20 Dept of shalakya Dr BRKR Government Ayurvedic medical college SR nagar Hyderabad Telangana
Dept of shalakya Government Ayurvedic hospital SR nagar Hyderabad Telangana
Hyderabad
TELANGANA
500038
India 
Phone  9985266955  
Fax    
Email  kanasuya9191@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anasuya K 
Designation  Principal and HOD Dept of shalakya Dr BRKR GAC 
Affiliation  Dr BRKR Government Ayurvedic Medical college 
Address  room no 20 Dept of shalakya Dr BRKR Government Ayurvedic medical college SR nagar Hyderabad Telangana
Dept of shalakya Government Ayurvedic hospital SR nagar Hyderabad Telangana
Hyderabad
TELANGANA
500038
India 
Phone  9985266955  
Fax    
Email  kanasuya9191@gmail.com  
 
Source of Monetary or Material Support  
Dr BRKR Government Ayurvedic Medical College , SR Nagar, Hyderabad, Telangana ,500038 
 
Primary Sponsor  
Name  Dr BRKR Government Ayurvedic Medical College 
Address  Dr BRKR Government Ayurvedic Medical College, SR Nagar, Hyderabad, Telangana - 500038 
Type of Sponsor  Government medical college 
 
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 Sreeharsha Vedantham  Government Ayurvedic Hospital  Room no 11, Department of Shalakya (Opthalmology), OPD
Hyderabad
TELANGANA 		 7207998633

sreeharshavedantham@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H350||Background retinopathy and retinalvascular changes. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shilajit rasayana , Reference: Charaka shamitha,Chikitsa sthana , Karaprachitiya pada1:3, 50-56 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Milk), Additional Information:
2Intervention ArmProcedure-netratarpaNam, नेत्रतर्पणम् (Procedure Reference: Ashtanga hridaya uttara tantra 13/6-9, Procedure details: Purva karma- Mukha ahyangana & swedana Pradhana karma- Akshitarpana with patolyadi ghrita Pascat karma - clean face with yava churna pradhan karma is done for a duration of 300 matra kala and then the drug/ghrita is removed ,making sure samyak tarpana laxanas are attained)
(1) Medicine Name: Patolyadi ghrita, Reference: Ashtanga hridaya uttara tantra 13/6-9, Route: Ocular, Dosage Form: Ghrita, Dose: 15(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Diagnosed case of T2DM for 10-30 years
2.Irrespective of race,religion & sex
3.case of NPDR +/- symptoms of hazyvision,blurred vision,floaters.
4.controlled Hypertension 
 
ExclusionCriteria 
Details  1.Diagnosed case of T2DM for more than 35 years
2.PDR & other vitreoretinal diseases
3. History of invasive ocular surgeries like vitreoretinal surgeries.
4.Pregnancy, poor glycemic control
5.Malignancy, T1DM 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Dates of Birth or day of the Week 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improve the grading of retinopathy atleast by 1 grade.  Day 0
Day 25
Day 46
Day 70 
 
Secondary Outcome  
Outcome  TimePoints 
Effect on glycemic index  Day 0
Day 60 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 4 
Date of First Enrollment (India)   01/05/2024 
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="0"
Months="1"
Days="22" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sriharsha.vedantham@gmail.com].

  6. For how long will this data be available start date provided 09-03-2024 and end date provided 09-03-2070?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Recent data suggests that diabetic retinopathy is the leading cause of hlindness in diabetis mellitus. It is estimated that there are approximately 33 million adults with diabetes in India. Thin number is likely to increase to 57.2 million by the year 2030.

Treatment for diabetic retinopathy is not cost-effective and though intra vitreal injections play a key-role in the management of DR its very difficult due to nature of progression of disease.

A study revealed that the prevalence of DR among persons with diabetes was 16.9% and the  prevalence of mild retinopathy was 11.8% It is evident that 90% of patients with DM for 15-20 years will have some of the retinopathy changes like aneurysm IRMA etc., Although modern medical science has made tremendous and remarkable progress and advance in the field of ophthalmology in recent times, the importance of ayurvedic treatment in the diseases of eyes cannot be ignored owing to the above mentioned pitfalls of the modern therapy. Ayurveda ocular therapies known as kriya kalpa has proven benefit on ocular pathologies.

Regardless of the method used to detect DR, the prevalence of DR among persons with diabetes ranged from 10% to 30.4%. A study reported a prevalence of 16.9%, which is comparable to other studies using plasma glucose as the criteria for DM; studies relying on self-report of DM had reported a higher prevalence of DM Prevalence of DR was higher in the urban examined population than in the rural population at 20.7% and 15.5% respectively.
 
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