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CTRI Number  CTRI/2023/06/053782 [Registered on: 12/06/2023] Trial Registered Prospectively
Last Modified On: 09/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Study The Effect Of Amalaki Siddha Ghee Tarpana In Dry Eye Disease 
Scientific Title of Study   A Randomized Controlled Clinical Study Of Amalaki Siddha Ghrita Tarpana In Dry Eye Disease 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krushna Mahakal 
Designation  MS Scholar Shalakyatantra 
Affiliation  Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital 
Address  Department of Shalakya Tantra,Bharati Vidyapeeth (Deemed to be university),College of Ayurved and hospital, Satara Road , pune 43 Pune MAHARASHTRA 411043 India

Pune
MAHARASHTRA
411043
India 
Phone  9511205716  
Fax    
Email  krushnamahakal06@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh Mulik 
Designation  Head of Department Shalakyatantra 
Affiliation  Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital 
Address  Department of Shalakya Tantra,Bharati Vidyapeeth (Deemed to be university),College of Ayurved and hospital, Satara Road , pune 43 Pune MAHARASHTRA 411043 India

Pune
MAHARASHTRA
411043
India 
Phone  9823491389  
Fax    
Email  drsantoshmulik@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Krushna Mahakal 
Designation  MS Scholar Shalakyatantra 
Affiliation  Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital 
Address  Department of Shalakya Tantra,Bharati Vidyapeeth (Deemed to be university),College of Ayurved and hospital, Satara Road , pune 43 Pune MAHARASHTRA 411043 India

Pune
MAHARASHTRA
411043
India 
Phone  9511205716  
Fax    
Email  krushnamahakal06@gmail.com  
 
Source of Monetary or Material Support  
BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY COLLEGE OF AYURVED 
 
Primary Sponsor  
Name  Dr Krushna Mahakal 
Address  Department of Shalakyatantra , Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital 
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 Krushna Mahakal  Bharati Vidyapeeth (Deemed to be university), College of Ayurved and hospital, Pune.  Department of Shalakyatantra, Bharati Vidyapeeth(Deemed to be university), College of Ayurved and hospital, Satara Road, Pune
Pune
MAHARASHTRA 		 9511205716

krushnamahakal06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BV(DU)COA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H00-H59||Diseases of the eye and adnexa. Ayurveda Condition: Other disorder of lacrimal system, (2) ICD-10 Condition:H049||Disorder of lacrimal system, unspecified. Ayurveda Condition: SARVAGATAKSHIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-carboxymethylcellulose eyedropCommonly used in form of Tear substitute
2Intervention ArmProcedure-netratarpaNam, नेत्रतर्पणम् (Procedure Reference: Sushruta Samhita, Procedure details: netratarpaNam will be given to patient for 10 mins once a day for seven days.)
(1) Medicine Name: Aamlaki siddha ghruta, Reference: bhavprakashnighantu, Route: Topical, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  patients suffering from mild to moderate Dry eye disease who are willing to participate will be selected 
 
ExclusionCriteria 
Details  patient with severe dry eye disease or any occular surface pathology or congenital anamolies of eye or one eyed patient or patient with eye lid disease or noncooperative patient 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
TFBUT test value to increase by 2-3 secs.
Schirmer-I test value to increase by 1-2 units (1mm-2mm) 		 7 days tarpana will be given,follow up will be on (7th and 14th day) 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the symptoms of Dryness, Eye fatigue, Redness, Burning sensation, Itching, Headache as compared to the standard drug mentioned in the subjective criteria  7 days tarpana will be given,follow up will be on (7th and 14th day) 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   19/06/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A randomized controlled clinical study of amalaki siddha ghrita tarpana will be done on 42 patients presenting with complaints of Dry eye disease and they will be divided into 2 groups (A&B). Group A will be provided with the trial drug amalaki siddha ghrita in the form of tarpana everyday once in the morning for 7 days. Group B will be provided with the control drug carboxymethylcellulose 0.5% eyedrop and will be advised to instill one drop 3 times a day. Study will be conducted for 14 days and observations will be taken and recorded starting from 0th day and follow up will be done on 7th day and on 14th day observations will be taken for any recurrences.Data recorded will be analyzed statistically and conclusion will be drawn based on it. 
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