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CTRI Number  CTRI/2023/08/056373 [Registered on: 10/08/2023] Trial Registered Prospectively
Last Modified On: 09/08/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive
Screening 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of ayurvedic treatment on diabetic retinopathy 
Scientific Title of Study   Experimental evaluation of retinoprotective activity of the polyherbal compound and adjunct effect of ayurvedic intervention and conventional standard of care in pramehaja timira w.s.r. non-proliferative diabetic retinopathy – A double arm exploratory trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1291-4999  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof. Manjusha R. 
Designation  Professor & HoD 
Affiliation  All India Institute of Ayurveda 
Address  Department of Shalakya Tantra 5th floor Academic Block All India Institute of Ayurveda

South
DELHI
110076
India 
Phone  08700794589  
Fax    
Email  hod-shalakya@aiia.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Prof. Pradeep Venkatesh 
Designation  Professor 
Affiliation  All India Institute of Medical sciences 
Address  Retina and uvea clinic Dr. RP Centre for ophthalmic Sciences

South
DELHI
110608
India 
Phone  9868971811  
Fax    
Email  venkyprao@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Akanksha Thakur 
Designation  PhD Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Department of Shalakya Tantra 5th floor Academic Block All India Institute of Ayurveda

South
DELHI
110076
India 
Phone  08700794589  
Fax    
Email  dr.akanksha.thakur@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda Gautampuri, Mathura Road, New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Akanksha Thakur  All India institute of Ayurveda  Shalakya eye opd no. 110 Hospital Block All India Institute of Ayurveda
South
DELHI 		 08700794589

dr.akanksha.thakur@gmail.com 
Akanksha Thakur  All India institute of Medical sciences  Retina and uvea clinic Dr. RP Centre for ophthalmic Sciences
South
DELHI 		 8700794589

dr.akanksha.thakur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E113||Type 2 diabetes mellitus with ophthalmic complications. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-standard of careHypoglycemic drugs anti VEGF injections
2Intervention ArmProcedure-dIpana , दीपन (Procedure Reference: sharangdhar paribhasha prakaran, Procedure details: oral medicines are given to the patient)
(1) Medicine Name: trikatu/giloy, Reference: Bhavprakash nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 7 Days
3Intervention ArmProcedure-takradhArA, तक्रधारा (Procedure Reference: ashtang hridaya, Procedure details: medicated buttermilk is poured over head)
(1) Medicine Name: musta/ amalaki, Reference: bhavprakash nighantu, Route: Topical, Dosage Form: Not Applicable, Dose: 100(g), Frequency: od, Duration: 7 Days
4Intervention ArmProcedure-udvartanam, उद्वर्तनम् (Procedure Reference: sushruta samhita, Procedure details: Medicated powders are rubbed against body)
(1) Medicine Name: triphala churna, Reference: bhavprakash nighantu, Route: Topical, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: od, Duration: 7 Days
5Intervention ArmProcedure-snehapAna-karma, स्नेहपान-कर्म (Procedure Reference: charak samhita, Procedure details: patient is made to drink medicated ghee in increasing dose as per the constitution & snehan lakshan of patient)
(1) Medicine Name: patoladi ghrita, Reference: Ashtang hridaya Uttar sthana, Route: Oral, Dosage Form: Ghrita, Dose: 700(NA), Frequency: od, Duration: 07 Days
6Intervention ArmProcedure-aBya~gga-karma, अभ्यंग-कर्म (Procedure Reference: Charak samhita, Procedure details: medicated oil is rubbed against body)
(1) Medicine Name: ksheerbala taila, Reference: Sahastrayoga, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 3 Days
7Intervention ArmProcedure-svedana-karma, स्वेदन-कर्म (Procedure Reference: charak samhita, Procedure details: hot sudation)
(1) Medicine Name: dashmoola kwatha, Reference: Charak samhita sutra, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 1(NA), Frequency: od, Duration: 3 Days
8Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charak Samhita, Procedure details: Medicines trivrut avaleha 60 g & triphala kwatha 100 ml are given to induce purgation)
(1) Medicine Name: trivrit avaleha, Reference: Ashtang Hridaya Kalpa , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(g), Frequency: od, Duration: 1 Days
9Intervention ArmProcedure-saMsarjana-kramaH, संसर्जन-क्रमः (Procedure Reference: charak samhita, Procedure details: advised diet as per the no. of vegas is advised after virechana)
(1) Medicine Name: NA, Reference: NA, Route: Oral, Dosage Form: Not Applicable, Dose: 1(NA), Frequency: bd, Duration: 7 Days
10Intervention ArmProcedure-bastikarma, बस्तिकर्म (Procedure Reference: CHARAK SAMHITA, Procedure details: MEDICATED MADHUTAILIKA BASTI IS ADMINISTRED TO THE PATIENT BOTH MORNING AND EVENING)
(1) Medicine Name: NA, Reference: NA, Route: Rectal, Dosage Form: Not Applicable, Dose: 1(NA), Frequency: bd, Duration: 8 Days
11Intervention ArmProcedure-biDAlaka:, बिडालक: (Procedure Reference: SHARANGDHAR Smhita, Procedure details: medicated paste is applied over lids devoid of lashes)
(1) Medicine Name: MUKKADI PURAMBADA, Reference: SAHASTRAYOGA, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1(NA), Frequency: od, Duration: 7 Days
12Intervention ArmProcedure-nasyam (viShopakramaH), नस्यम् (विषोपक्रमः) (Procedure Reference: CHARAK SAMHITA, Procedure details: MEDICATED OIL IS INSTILLED IN EACH NOSTRIL)
(1) Medicine Name: ANU TAILA, Reference: CHARAK SAMHITA, Route: Nasal, Dosage Form: Not Applicable, Dose: 1(drops), Frequency: od, Duration: 7 Days
13Intervention ArmDrugClassical(1) Medicine Name: VASAKADI KASHAYA, Reference: Vangsen samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1Patients suffering from Type II DM having Mild to Moderate Non-Proliferative Diabetic Retinopathy
2Patients willing for Ayurveda treatment protocol.
3Patients having history of Diabetes mellitus more than 5 years.
4Patients of DR who have undergone modern medical management and Laser Photocoagulation therapy previously for the same but with persisting symptoms and/or signs will also be included in the study.
5Taking oral hypoglycemic drugs or insulin
 
 
ExclusionCriteria 
Details  1History of glaucoma
2Patients with moderate to severe Cataractous changes.
3Patients having proliferative and advanced Diabetic Retinopathy changes.
4Patients with any other complications of Diabetes like nephropathy and neuropathy.
5Patient having systemic diseases like hypertension, thyroid etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1To assess the retino-protective activity of polyherbal compound in the selected in-vivo model in terms of its anti- angiogenic activity
2To evaluate the change in the retinal oedema & retinal haemorrhages in patients with Non-Proliferative Diabetic Retinopathy in terms of OCT and Fundus photographs. 		 80 days including 40 days follow up 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in number & size of hard & soft exudates in terms of Fundus photographs.
2.Change in the quality of ocular health of patients of NPDR in terms of EDTRS visual acuity.
 		 80 days including 40 days follow up 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   25/08/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   no publication related to thesis 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 01-06-2026 and end date provided 01-06-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is planned to evaluate the add on effect of ayurvedic protocol on non proliferative Diabetic retinopathy when used in addition to standard of care. Diabetic retinopathy is one of the major neurovascular complications of diabetes and is a leading cause of blindness in adults of the working-age group. Almost all patients with type 1 diabetes develop retinopathy in about 15 years. In those with Type 2 DM, the risk of Diabetic Retinopathy increases with the duration of diabetes, accompanying hypertension and smoking. Diabetics have a 20-25 times greater risk of blindness as compared to the normal population. Ninety-three million people are globally affected by diabetic retinopathy. 

On viewing the above burden of DR in society an effective and comprehensive approach is necessary to address this global problem. Though modern medicine has solutions in early NPDR and NPDR stages, like Photocoagulation, intra-vitreal steroids and Anti VEGF injections but these too have their limitations in some cases. Thus, in this study an attempt has been made to explore the possibilities to prevent and check the progression of non-proliferative diabetic retinopathy with Ayurveda interventions along with comprehensive medicine.

Strategies aimed at therapeutic interventions in diabetic retinopathy were based on the understanding of etiological and pathological mechanisms behind its development and progression in both modern medicine and Ayurveda.

 
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