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CTRI Number  CTRI/2025/02/080024 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 03/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study on How Body Type Affects Diabetic Eye Disease and the Effect of Triphala Ghrita Treatment on Eye Health 
Scientific Title of Study   Assessment of Association between Daihik Prakriti and Diabetic Retinopathy and Response to Triphala Ghrita Netratarpan 
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 HAGE H TUMPI 
Designation  MD SCHOLAR DEPARTMENT OF KRIYA SHARIR 
Affiliation  PT. KHUSHILAL SHARMA GOVT(AUTO) AYURVEDA COLLEGE & INSTITUTE, BHOPAL,MADHYA PRADESH 
Address  ROOM NO 08 DEPARTMENT OF KRIYA SHARIR SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH
ROOM NO 08 DEPARTMENT OF KRIYA SHARIR SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH
Bhopal
MADHYA PRADESH
462003
India 
Phone  6238981880  
Fax    
Email  tumpyhageh11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RAJEEV MISHRA 
Designation  LECTURER DEPARTMENT OF KRIYA SHARIR 
Affiliation  PT. KHUSHILAL SHARMA GOVT(AUTO) AYURVEDA COLLEGE & INSTITUTE, BHOPAL,MADHYA PRADESH 
Address  ROOM NO 08 DEPARTMENT OF KRIYA SHARIR SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH
ROOM NO 08 DEPARTMENT OF KRIYA SHARIR SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH
Bhopal
MADHYA PRADESH
462003
India 
Phone  9425360283  
Fax    
Email  drrajeev21mishra@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SHWETA AGRAWAL 
Designation  LECTURER DEPARTMENT OF SHALAKYA TANTRA 
Affiliation  PT. KHUSHILAL SHARMA GOVT(AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL MADHYA PRADESH 
Address  ROOM NO 223 DEPARTMENT OF SHALAKYA TANTRA SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH
ROOM NO 223 DEPARTMENT OF SHALAKYA TANTRA SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH
Bhopal
MADHYA PRADESH
462003
India 
Phone  7974249965  
Fax    
Email  dr.shwetaagrawal2@gmail.com  
 
Source of Monetary or Material Support  
PT. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL 462003 MADHYA PRADESH INDIA 
 
Primary Sponsor  
Name  PT. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE 
Address  SCIENCE HILLS BEHIND MANIT,KOLAR BYPASS NEHRU NAGAR BHOPAL,MADHYA PRADESH 
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 HAGE H TUMPI  PT KHUSHILAL SHARMA GOVT AUTONOMOUS AYURVEDA COLLEGE & INSTITUTE   ROOM NO 08 DEPARTMENT OF KRIYA SHARIR SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH
Bhopal
MADHYA PRADESH 		 6238981880

tumpyhageh11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Pt Khushilal Sharma Government Autonomous Ayurveda college and institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H348||Other retinal vascular occlusions. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-netratarpaNam, नेत्रतर्पणम् (Procedure Reference: sushruta samhita uttara tantra 18 kriya kalpa adhyay , Procedure details: Purvakarma Deepan Pachana with Eranda bhrista haritaki Nasya karma with anutaila 2 drops per nostril for 7 days followed by netra tarpan karma with triphala ghrita)
(1) Medicine Name: Triphala Ghrita, Reference: Astanga Hridaya uttara tantra 13/10-11, Route: Ocular, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 28 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Diagnosed cases of non-proliferative diabetic retinopathy with type 2 diabetes mellitus.
2.Participants of either sex between the age 30 to 70 years.
3.Participants willing to participate in the study and provide their written consent.
 
 
ExclusionCriteria 
Details  1.Individual with retinopathy or ocular pathology other than diabetic retinopathy.
2.Participants with mature cataract, corneal opacity, glaucoma, diabetes insipidus, proliferative diabetic retinopathy.
3.Pregnant women and lactating mothers.
4.Participants not willing to give written consent for participation in the study.
5.Any other conditions which may jeopardize the result of study will be excluded.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
It is expected that at the end of the study we will be able to explore the association between occurrence of non-proliferative diabetic retinopathy and Daihik prakriti, which will be helpful in the present era to assess the susceptibility to non-proliferative diabetic retinopathy based on differences in prakriti. It is further expected that this study would be able to provide the response to Triphala ghrita tarpan in non-proliferative diabetic retinopathy in relation to prakriti.  12 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
   
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 
Date of First Enrollment (India)   15/02/2025 
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="2"
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 - NO
Brief Summary  

Diagnosed participants of non-proliferative diabetic retinopathy fulfilling the inclusion criteria will be selected from OPD and IPD of Shalakya Tantra department of the institute and through health camps organised under the department. Participants will be selected through purposive sampling and detailed information will be collected through a specially designed proforma.

SAMPLE SIZE: 50

SAMPLE TECHNIQUE: Purposive sampling

DURATION OF STUDY: 12 months

DURATION OF THERAPY: 60 days

FOLLOW UP: After 1 month

PLAN OF THERAPY: 3 days-Deepana pachana

                                       7 days- Nasya

                                       7 days- rest

                                       7 days- Tarpan (4 sitting) with the interval of 7 days in each sitting

 
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