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CTRI Number  CTRI/2025/04/084536 [Registered on: 11/04/2025] Trial Registered Prospectively
Last Modified On: 07/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Haritakyadi kwatha pana and kokila varti anjana in Diabetic Retinopathy  
Scientific Title of Study   A Randomized clinical trial to compare the efficacy of Haritakyadi Kwatha Pana And Kokila Varti Anjana with and without Yogic therapy in Madhumehajanya Timira W.S.R to 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 Shweta Savalagi  
Designation  Post Graduate scholar  
Affiliation  Shri Vijay Mahantesh Ayurvedic Medical College Ilkal 
Address  Room no 02, Dept of Department Eye and ENT OPD Shri Vijay Mahantesh Ayurvedic Medical College Ilkal Karnataka India 587125
Room no 02, Dept of Department Eye and ENT OPD RPK ayurvedic hospital and Shri Vijay Mahantesh Ayurvedic Medical College Ilkal Karnataka India 587125
Bagalkot
KARNATAKA
587125
India 
Phone  8088889246  
Fax  -  
Email  shwetasavalagi1369@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh pujari  
Designation  Associate professor  
Affiliation  Shri Vijay Mahantesh Ayurvedic Medical College Ilkal 
Address  Room no 02, Dept of Department Eye and ENT OPD Shri Vijay Mahantesh Ayurvedic Medical College Ilkal Karnataka India 587125
Room no 02, Dept of Department Eye and ENT OPD RPK ayurvedic hospital and Shri Vijay Mahantesh Ayurvedic Medical College Ilkal Karnataka India 587125
Bagalkot
KARNATAKA
587125
India 
Phone  8951079943  
Fax  -  
Email  vinu2966@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shweta Savalagi  
Designation  Post Graduate scholar  
Affiliation  Shri Vijay Mahantesh Ayurvedic Medical College Ilkal 
Address  Room no 02, Dept of Department Eye and ENT OPD Shri Vijay Mahantesh Ayurvedic Medical College Ilkal Karnataka India 587125
Room no 02, Dept of Department Eye and ENT OPD RPK ayurvedic hospital and Shri Vijay Mahantesh Ayurvedic Medical College Ilkal Karnataka India 587125
Bagalkot
KARNATAKA
587125
India 
Phone  8088889246  
Fax  -  
Email  shwetasavalagi1369@gmail.com  
 
Source of Monetary or Material Support  
Shri Vijay Mahantesh Ayurvedic Medical College Ilkal Bagalkot Karnataka India 587125 
 
Primary Sponsor  
Name  Shri Vijay Mahantesh Ayurvedic Medical College IKAL 
Address  Shri Vijay Mahantesh Ayurvedic Medical College Ilkal Karnataka India 
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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrShweta Savalagi  Shri Vijay Mahantesh Ayurvedic Medical College Ilkal  Post Graduate Scholar Department of Shalakya Tantra OPD no.2 RPK Ayurvedic Hospital Ilkal
Bagalkot
KARNATAKA 		 8088889246
-
shwetasavalagi1369@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ShriVijayMahanteshAyurvedicMedicalCollegeIlkalKarnatakaIndia  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H352||Other non-diabetic proliferative retinopathy. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Haritakyadi kwatha , Reference: Sushruta Sahmhita Dalhana commentary Nibandha sangraha by Trivikram Yadav Sharamana Chapter 11 Prameha chikitsa adhyaya Chowkambha Sanskrit Varanasi Page number 450 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: Orally advised Haritakyadi kwath and once Anjana locally evary day with yogaabhyasa every day with proper diet
2Intervention ArmDrugClassical(1) Medicine Name: Kokoila varti, Reference: Yadavji Trikamji(editor), Sushruta Samhita of Sushruta, Uttaratantra, chapter 18, verse no.59, Varanasi; Chaukamba samskruta samsthana; Reprint 2014 :637, Route: Topical, Dosage Form: Varti/ Suppository, Dose: 1(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients who are fit for Anjana karma are included with features of Non-proliferative Diabetic Retinopathy.
2. Patients of Diabetic Mellitus (TYPE 1 and TYPE 2) between the ages 30-70 years having ophthalmoscopically detectable Diabetic Retinopathy changes.
3. Patients with history of longer duration of type 1 and type2 Diabetes Mellitus having symptoms of Diabetic Retinopathy will be taken for study.
4. Patients with good glycaemic control will be taken for study.
5. Patients who are fit for yogic therapy are included.  
 
ExclusionCriteria 
Details  1. Patients with proliferative Diabetic Retinopathy, and other advanced diabetic eye diseases are excluded.
2. Patients with aided visual acuity less than 6/60 at Snellen’s distant chart.
3. Patients with other type of vascular retinopathies like Hypertensive Retinopathy, Retinopathies of blood dyscrasias, Gestational Diabetic Retinopathy, Retinopathy of prematurity, Sickle cell Retinopathy and Diabetic Maculopathy are excluded.
4. Patients with other systemic diseases like renal disease, Hyperlipidaemia, and Cardiovascular diseases are excluded.
5. Patients who undergone abdominal surgeries, pelvic surgeries and vertebral surgeries and who are having hernia , neck and back injury and pregnant women are excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduced Microaneurysms, Dot and blot hemorrhages, Hard Exudate, and Cotton wool spots. Visual improvement is seen   12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Diabetic level controlled & Improvement of vision  90 days 
 
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   N/A 
Date of First Enrollment (India)   25/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/04/2025 
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)  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 (Others) -  NIL

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response (Others) -  NIL
  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 - Data are available indefinitely at (Link to be included shwetasavalagi1369@gmail.com).

  6. For how long will this data be available start date provided 30-09-2024 and end date provided 20-09-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Ayurvedic description on Madhumeha finds very much resemblance with Diabetes mellitus in etiopathogenesis and management. Prameha nidana’s include both beeja dosha and Aahara vihara’s, Certain etiological factors in Prameha are Achakshushya, which causes diabetic changes in the eye especially in the retina. In present era due to the mental stress and sedentary life style, lack of physical activity and changing dietary food habit leading to many of the metabolic diseases, diabetes is one among them, in further stage there is high chances of getting diabetic retinopathy.

The current treatment in modern for Diabetic Retinopathy is laser photocoagulation, Anti VEGF Injections and Vitrectomy etc, which are invasive, require frequent usage and which is expensive, even though lead to many complications such as vitreous hemorrhage thus, all these treatments have their own limitations and complications.  


 
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