| CTRI Number |
CTRI/2026/01/100686 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Animal and clinical study is to find out whether Chakshushya Basti an Ayurvedic treatment is effective and safe in reducing dryness irritation and discomfort in people suffering from Dry Eye syndrome |
|
Scientific Title of Study
|
Experimental and clinical study to evaluate the effect of Chakshushya Basti in Dry Eye syndrome |
| 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 Prapulla K |
| Designation |
Assistant Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and hospital, hassan |
| Address |
OPD NO 5
Panchakarma Department
SDM College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan
573201
Hassan
KARNATAKA
573201
India |
| Phone |
8095369407 |
| Fax |
|
| Email |
prapulla6k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lohith BA |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and hospital, hassan |
| Address |
OPD NO 5
Panchakarma Department
SDM College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan
573201
Hassan
KARNATAKA
573201
India |
| Phone |
9886749168 |
| Fax |
|
| Email |
drlohithba@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prapulla K |
| Designation |
Assistant Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and hospital, hassan |
| Address |
OPD NO 5
Panchakarma Department
SDM College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan
573201
Hassan
KARNATAKA
573201
India |
| Phone |
8095369407 |
| Fax |
|
| Email |
prapulla6k@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM Road, Thanniruhalla, Hassan 573201, Karnataka state, India |
|
|
Primary Sponsor
|
| Name |
Dr Prapulla K |
| Address |
SDM COLLEGE OF AYURVEDA AND HOSPITAL
BM ROAD THANNIRUHALLA
HASSAN
573201 |
| Type of Sponsor |
Other [Individual] |
|
|
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 Prapulla K |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
OPD NO 5
Panchakarma
BM Road Thanniruahlla Hassan
Hassan
KARNATAKA |
8095369407
prapulla6k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara college of Ayurveda , Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H041||Other disorders of lacrimal gland. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: charaka kalpasthana 4th chapter, Procedure details: Kosta Shodana for 1 day followed by chakshushya basti in modified kaala basti pattern for the duration of 9 days.
2 basti per day from 3rd day onwards, & last two days 2 anuvasana basti )
| | 2 | Comparator Arm (Non Ayurveda) | | - | Carboxy methyl cellulose sodium eye drops | Dosage form:- Topical
2 drops 4 times per day for the duration of 30 days.
|
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Experimental Study
1. Healthy Murine model of either gender will be considered.
2. Weight- 150 to 250 g.
Clinical Study
1.Subject between age group of 20-50 years
2.Subjects irrespective of sex and religion
3.Subjects fit for basti karma
4.Subjects having minimum three ocular symptoms of 5.Dry eye syndrome as per diagnostic criteria
6.Subjects who are ready to sign the consent form |
|
| ExclusionCriteria |
| Details |
Experimental Study
1. Weight less than 150g and greater than 250 g.
2. Pregnant and diseased murine model.
3. Murine model that are under trial of other experiments or previous experiment
Clinical Study
1.Known cases of severe ophthalmic conditions like Steven Johnsons, Chemical – Thermal Radiation burns, Idiopathic atrophy, Trachoma, Ocular pemphigoid.
2.Known cases of Neuroparalytic Keratitis, post-measles infection of cornea, Pterygium, Tumours, low grade bacterial/viral conjunctivitis
3.Any condition which jeo paradise the study
4.Known cases of Systemic disorder and autoimmune disorder
5.Diagnosed cases of inflammatory and infective ocular conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Tear Film Stability assessed by Tear Break-Up Time (T-BUT) before and after intervention.
2. Increase in Tear Secretion evaluated by Schirmer’s Test readings.
3. Histopathological improvement in corneal epithelial cell integrity and reduction in desquamation through Hematoxylin–Eosin staining (experimental arm only)
|
1st assessment - Before Treatment (0th Day)
2nd assessment -end of Basti treatment (10th day)
3rd assessment- 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Reduction in subjective symptoms such as dryness itching burning foreign body sensation eye strain assessed by
OSDI (Ocular Surface Disease Index) questionnaire
Dry Eye Grading Severity Scheme
2 Improvement in Visual Acuity
3 Observation of Samyak Niruha Basti Lakshana
4 Assessment of safety tolerance by monitoring any Adverse Drug Reactions (ADR) |
1st assessment Before Treatment (0th Day)
2nd assessment By end of Basti treatment (10th day)
3rd assessment by 30th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/09/2026 |
| 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="3"
Months="6"
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
|
This study is planned to assess the role of Chakshushya Basti in the management of Dry Eye Syndrome through both experimental and clinical evaluation. An experimental study will be carried out on a Benzalkonium Chloride–induced murine model to observe changes in tear film stability and corneal histopathology. The clinical arm involves an open-label randomized controlled trial comparing Chakshushya Basti with Carboxymethylcellulose sodium eye drops. Assessment will be done using Tear Break-Up Time, Schirmer’s test, OSDI scores, histological findings, and safety parameters. The study intends to provide scientific support for the therapeutic usefulness of Chakshushya Basti in Dry Eye Syndrome. |