| 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
|
|
|
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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H111||Conjunctival degenerations and deposits. Ayurveda Condition: PISHTAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Comparator Arm (Non Ayurveda) | | - | Flurbiprofen Eye Drop | Non-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)
|