| CTRI Number |
CTRI/2026/01/101575 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| 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
|
Effectivness of an Ayurvedic Eyewash and Herbal Ointment on Treating Eyelid Inflammation(Blepharitis) |
|
Scientific Title of Study
|
An open labelled randomised controlled clinical study to evaluate the efficacy of sphatika eye wash and rasanjanadi ointment in the management of praklinnavartma with special reference to seborrhoeic blepharitis |
| 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 Jidnyasa Kishor Gulale |
| Designation |
PG SCHOLAR - MS SHALAKYA |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
OPD No. 108 Dept of shakakya tantra, Parul Ayurved Hospital, Parul university, Waghodia, Dist. Vadodara, Limda, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8975925389 |
| Fax |
|
| Email |
jidnyasagulale18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalaka More |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
OPD NO. 108,Dept of shalakya tantra,Parul Ayurved Hospital, Parul university, Waghodia, Dist. Vadodara, Limda, Gujarat
Valsad
GUJARAT
391760
India |
| Phone |
7057894025 |
| Fax |
|
| Email |
vdshalakapawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalaka More |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
OPD NO. 108,Dept of shalakya tantra,Parul Ayurved Hospital, Parul university, Waghodia, Dist. Vadodara, Limda, Gujarat
GUJARAT
391760
India |
| Phone |
7057894025 |
| Fax |
|
| Email |
vdshalakapawar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of ayurved |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurveda |
| Address |
Parul Ayurved Hospital, Parul university, Limda, Waghodia Gujarat 391760 |
| 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 |
EYE OPD no 108 ,Dept. Of shalakya tantra, LIMDA , WAGHODIA, VADODARA GUJARAT
Vadodara
GUJARAT |
7057894025
vdshalakapawar@gmail.com |
|
|
Details of Ethics Committee
|
| 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:H010||Blepharitis. Ayurveda Condition: PRAKLINNAVARTMA/KAPOTKLISHTA-VARTMA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sphatik Eye wash, Reference: Rasa Tarangini 11/195, Route: Ocular, Dosage Form: Sheeta/ Hima, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasanjanadi Ointment, Reference: Vangsena 36/539-540, Route: Ocular, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | | - | Baby Shampoo and Ciprofloxacin ointment | Baby shampoo will be used as an eyewash in comparison to Sphatik eye wash and Ciprofloxacin ointment will be used in comparison to Rasanjanadi Eye ointment |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients NOT having diseases like corneal ulcer, ectropion, entropion, trichiasis, dacryocystitis, dry eye, lagophthalmous, acute chronic infective conjunctivitis etc. 2. Patients N0T suffering from specific eyelid disorders like tumor, carcinoma etc. |
|
| ExclusionCriteria |
| Details |
1. Patients having diseases like corneal ulcer, ectropion, entropion, trichiasis, dacryocystitis, dry eye, lagophthalmous, acute chronic infective conjunctivitis etc. 2. Patients suffering from specific eyelid disorders like tumor, carcinoma etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the changes in relevant clinical parameters (e.g., eyelid margin
inflammation, scaling, itching, redness) |
Study Duration - 15 days
Follow up – First on 8th day
Second on 15th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No pathological findings in slit lamp examination post intervention |
Study Duration - 15 days
Follow up – First on 8th day
Second on 15th day.
|
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
30/01/2026 |
| 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 Vartma Patala/Mandala (eye lids) is one of the anatomical part of eye which provides
protection and rest to the eye ball and is also the site for pathogenesis of the diseases called as
Vartma Gata Rogas [1]. These Vartma Gata Rogas are 21 in number as per Acharya Sushruta
and 24 in number as per Acharya Vagbhata.[2]
Praklinnavartma is one among the 21 types of diseases of Vartma, it is characterized by
predominance of Klinnata (congestion) due to Kapha Dosha. [3]
Acharya Sushruta has described the rupa of the Praklinnavartma such as: [4]
Arujam- That means painless/mild pain (acc to Dalhana)
Bahytah shunam –Swelling in the external surface of eyelid
Antah klinnam- Sticky exudation in inner part of eyelid
Srava- Discharge
Kandu- Itching sensation
Toda- Pricking pain sensation
Samprapti/Pathogenesis - Praklinnvartma is mainly Kapha pradhana disease. So the
kapha vardhaka and the Achakshushaya Ahara, Vihara will lead to the vitiation of the
Agni, further causing the vitiation of the Rasa which leads to the kaphavriddhi. This
increased kapha via the Sira and the Srotas and with the help of the prana, udana and
the vyana vayu will get situated in the vartma of the netra. There the dosha and the
dushaya sammurchana will lead to the Rakta and the Mamsa dushti and hence leading
to the kleda vriddhi and then Praklinnvartma. [5]
SEBORRHOEIC BLEPHARITIS:
Symptoms:
Deposition of whitish material (soft scales) at the lid margin associated with mild
discomfort, irritation, occassional watering and a history of falling of eyelashes. Signs:
1.Accumulation of white dandruff like scales is seen on the lid margin, among the
lashes. On removing these
scales, the underlying surface is found to be hyperaemic and greasy. 2.The lashes fall out easily but are replaced quickly without distortion.
3.Lid margin is thickened and the sharp posterior border tends to be rounded leading
to epiphora in long standing cases. Treatment:
1.General measures include improvement of health and balanced diet. 2.Associated seborrhoea of the scalp should be adequately treated. 3.Local measures include removal of scales from the lid margin with help of
lukewarm solution of 3% soda bicarb or baby shampoo and frequent application of
combined antibiotic and steroid ointment at the lid margin. [6]
Acc to Ayurveda, Praklinnavartma should be treated with seka, ashchyotana, nasya,dhumapana and anjana after eliminating the doshas by oleation and applying
saturation according to respective dosha |