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CTRI Number  CTRI/2025/04/084127 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 03/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Efficacy of Shunthyadi Aschyotana (Eye Drop), Triphaladi Ghrita Pana (Orally) with and without Triphaladi Ghrita Nasya in the management of Dry Eye Disease (Shushkakshipaka)  
Scientific Title of Study   Efficacy of Shunthyadi Aschyotana (Eye Drop), Triphaladi Ghrita Pana (Orally) with and without Triphaladi Ghrita Nasya in the management of Dry Eye Disease (Shushkakshipaka) – An Open Labelled Randomized Comparative Clinical Trial 
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 Meghna Motwani 
Designation  Assistant Professor 
Affiliation  J S Ayurved Mahavidyalaya, Nadiad 
Address  Department of Shalakyatantra J S Ayurveda Mahavidyalya College road Nadiad

Kheda
GUJARAT
387001
India 
Phone  9712321618  
Fax    
Email  meghnamotwani22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ganga R Hadimani 
Designation  Professor 
Affiliation  J S Ayurved Mahavidyalaya, Nadiad 
Address  Department of Shalakyatantra J S Ayurveda Mahavidyalya College road Nadiad

Kheda
GUJARAT
387001
India 
Phone  8780067570  
Fax    
Email  gangupatil2001@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ganga R Hadimani 
Designation  Professor 
Affiliation  J S Ayurved Mahavidyalaya, Nadiad 
Address  Department of Shalakyatantra J S Ayurveda Mahavidyalya College road Nadiad


GUJARAT
387001
India 
Phone  8780067570  
Fax    
Email  gangupatil2001@rediffmail.com  
 
Source of Monetary or Material Support  
Sundar Ayurveda teaching pharmacy J S Ayurveda college College road Nadiad 387001 Gujarat, India 
 
Primary Sponsor  
Name  J S Ayurveda college and P D Patel Ayurveda hospital 
Address  J S Ayurveda college and P D Patel Ayurveda hospital College Road Nadiad - 387001 Gujarat, India Nadiad 
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 
Dr Meghna Motwani  P D Patel Ayurveda hospital  Department of Shalakya Tantra J S Ayurveda college and P D Patel Ayurveda hospital Kheda GUJARAT
Kheda
GUJARAT 		 9712321618

meghnamotwani22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for human research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H049||Disorder of lacrimal system, unspecified. Ayurveda Condition: SUSHKAKSHIPAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Triphaladi Ghrita, Reference: Bhaishjyaratnavali, Netrarogadhikara – 241-248, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Shunthyadi Aschyotana, Reference: Anubhuta, Route: Ocular, Dosage Form: Ghrita, Dose: 1(ml), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
3Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Su. Chi. 40/25-30, Procedure details: • The patient will be asked to lie in supine position extending his/her arms and legs and head slightly extended. • Later tip of the nose will be drawn upward by Vama Pradeshni (left index finger). • With right hand the lukewarm medicament will instilled into both nostrils using Gokarna. )
(1) Medicine Name: Triphaladi Ghrita, Reference: Bhaishjyaratnavali, Netrarogadhikara – 241-248, Route: Nasal, Dosage Form: Ghrita, Dose: 8(drops), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Irrespective of gender, caste, religion and socio-economic status.
2. Patients between age group of 18 and 60 years.
3. Patients presenting with minimum 3 symptoms and at least two positive tests of Dry Eye Disease.
 
 
ExclusionCriteria 
Details  1. Dry Eye due to any local cause e.g., Chemical Burn, Xerosis.
2. Dry Eye due to systemic disease like Sjogren’s Syndrome.
3. Patients on Steroids, Oral Contraceptive Pills, Estrogen Replacement Therapy, or any other medication such as Antispasmodic drugs like Atropine that may adversely affect the outcome of the study.
4. Persistent contact lens users.
5. Patients having chronic debilitating diseases like HIV, Tuberculosis, Malignancy, uncontrolled Diabetes Mellitus and uncontrolled Hypertension, Pregnant ladies and lactating mothers.
 
 
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 
Relief in signs and symptoms of dry eye disease.  Relief in signs and symptoms of dry eye disease in 4-8 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in associated complaints of dry eye disease.   Relief in associated complaints of dry eye disease in 4-8 weeks. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 
Date of First Enrollment (India)   01/05/2025 
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="2"
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 - NO
Brief Summary  

Cases of Dry Eye Disease is rising day by day due to various etiological factors; excessive usage of VDT (Visual Display Terminal) gadgets, prolonged usage of medications like PPIs, hypertensives, anti-depressants and increased use of contact lenses etc. Treatment of contemporary medicine consists, the tear lubricants mentioned are a failure in reproducing the tears because the natural tears are a complex mixture of lipids, mucin and water. It may reduce the severity of dry eye,but it can’t break the root cause of pathology which often results in recurrence. Other lacunas include high costing and lifelong dependency on the drugs. So, to provide good combination of medicine in ayurveda research is conducted on the efficacy of Shunthyadi Aschyotana (Eye Drop), Triphaladi Ghrita Pana with Triphaladi Ghrita Nasya.  Assessment will be done based on special proforma through scoring pattern and will be analyzed statistically with the help of paired “t” test (paired and unpaired), Wilcoxon statistical tool, where > 0.05=insignificant result, <0.05=significant result and <0.001= highly significant result.

 
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