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CTRI Number  CTRI/2025/12/098551 [Registered on: 05/12/2025] Trial Registered Prospectively
Last Modified On: 09/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of eye ointment containing shunthi like herbal drugs in Pinguecula an eye disease 
Scientific Title of Study   An Open Labelled Randomized Controlled Clinical Study To Evaluate The Efficacy Of Nagaradi Eye Ointment In The Management Of Pishtaka With Special Reference To Pinguecula. 
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. Gangane Prasad Laxman 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved, Parul University 
Address  108, Department of Shalakyatantra, Parul Institute of Ayurved, Parul University, Limda, Waghodia

Vadodara
GUJARAT
391760
India 
Phone  7385037102  
Fax    
Email  prasadgangane333@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shalaka More 
Designation  Asso. Professor 
Affiliation  Parul Institute of Ayurved, Parul University 
Address  108, Department of Shalakyatantra, Parul Institute of Ayurved, Parul University, Limda, Waghodia

Vadodara
GUJARAT
391760
India 
Phone  7057894025  
Fax    
Email  vdshalakapawar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shalaka More 
Designation  Asso. Professor 
Affiliation  Parul Institute of Ayurved, Parul University 
Address  108, Department of Shalakyatantra, Parul Institute of Ayurved, Parul University, Limda, Waghodia

Vadodara
GUJARAT
391760
India 
Phone  7057894025  
Fax    
Email  vdshalakapawar@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Parul Institute of Ayurved 
Address  Parul Institute of Ayurved, Parul University, Limda, Waghodia 
Type of Sponsor  Private 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 Shalaka More  Parul Ayurved Hospital  OPD No.108, Department of Shalakyatantra, Parul Institute of Ayurved, Parul University, Limda, Waghodia
Vadodara
GUJARAT 
7057894025

vdshalakapawar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIA/IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H111||Conjunctival degenerations and deposits. Ayurveda Condition: PISHTAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Nagaradi Eye Ointment, Reference: Ashtang Hridayam Uttarsthan 16th chapter 17th shloka, Route: Ocular, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: hs, Bhaishajya Kal: Antarabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: apply ointment inside eyelids
2Comparator Arm (Non Ayurveda)-Flurbiprofen Eye DropNon-Steroid Anti-Inflammatory Drug
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients irrespective of gender, caste, religion.
Patients presenting signs & symptoms of Pishtaka (Pinguecula).
Patients who are ready to give consent. 
 
ExclusionCriteria 
Details  Patients with history of any ocular surgeries.
Patients with ocular manifestations due to serious systemic illness.
Any individual with uncontrolled systemic disorders like Hypertension, Diabetes, etc.
Any chronic disease like Carcinoma, HIV or any other immuno-compromised disorder.
Pregnant woman.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Relief from symptoms of Pishtak  7th, 15th, 30th day 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
No Recurrance  7th, 15th, 30th day 
 
Target Sample Size
Modification(s)  
Total Sample Size="76"
Sample Size from India="76" 
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)   25/01/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The importance of Ayurveda in the global scenario is because of its holistic approach towards a positive lifestyle.

The study of disease is the study of man and his environmental factors; hence the key to man’s health lies largely in his environment. Much of man’s ill health can be traced to adverse environmental factors such as water pollution, soil pollution, air pollution, poor housing condition, presence of ignorance about the spread of diseases. The above mentioned factors are responsible for the Nidana or causes of the disease called Pistaka (Pinguecula). Acharya Susrutha has mentioned 76 eye diseases based on Videha Tantra.

Acharya Charaka has casually described according to Dosha, while Vagbhata, Bhavaprakasha, Sharangadhara, etc. have also described the eye diseases and their management with slight variation in the number of diseases and their sign and symptoms.

Now a days due to urbanization and very much changes in lifestyles and due to different causative factors like exposure to the sun, smoke, dust, heat, etc the disease Pistaka (Pinguecula) is very commonly seen.

Acharya Sushruta described Pistaka is one of the Shuklagata netrarogas. It is Kapha dosha predominant disease, it is Ousadha sadhya vyadhi 

In Pistaka vyadhi shukla mandala is spread with white round and fresh papule nodular development, seen like whitish rice flour and fresh like water so it’s called as Pistaka.

Pingueculae are among the more common conjunctival disorders with prevalence rates ranging from 22.5% to 97%. Pingueculae are benign, white to yellow raised lesions which can sometimes have a lipid-like appearance. Pingueculae are typically located at the three and nine o’clock positions on the bulbar conjunctiva near the sclerocorneal junction but do not cross into the cornea.

In Astanga Hridaya Uttarsthana, Acharya Vagabhatta has mentioned it in.(A.H.U.10- Sandhisitasit-rogvidnyaniyam Adhyaya).

·         A Pinguecula (plural pingueculae) is an innocuous but extremely common asymptomatic elastotic degeneration of the conjunctival stroma. A yellow–white mound or aggregation of smaller mounds is seen on the bulbar conjunctiva adjacent to the limbus. Inflammation of Pinguecula is called as Pingueculitis. It is characterized by pain, redness, watering and foreign body sensation in eyes.

·         The cause is believed to be actinic damage, similar to the aetiology of pterygium, which pinguecula resembles histologically; the distinction is that the limbal barrier to extension has remained intact with a pinguecula, though transformation can occur.

(Kanski’s- Clinical Ophthalmology, By-Brad Bowling. Chapter-5-Conjunctiva, pg. no-162)

 

 
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