| CTRI Number |
CTRI/2026/03/106356 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on the effectiveness of Draksha Ghrita Eye Drops in patients with Dry Eye Disease |
|
Scientific Title of Study
|
An Open-Label Randomized Controlled Clinical Trial to
Evaluate the Efficacy of Topical Draksha Ghrita for Treatment
of Dry Eye Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajisha P |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalakya Tantra,
Faculty of Ayurveda,
Institute of Medical sciences,
Banaras Hindu University,
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8606117260 |
| Fax |
|
| Email |
ajishababup96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Manoj Kumar |
| Designation |
Professor and Head |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalakya Tantra,
Faculty of Ayurveda,
Institute of Medical sciences,
Banaras Hindu University,
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9793127744 |
| Fax |
|
| Email |
mkumarbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajisha P |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalakya Tantra,
Faculty of Ayurveda,
Institute of Medical sciences,
Banaras Hindu University,
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8606117260 |
| Fax |
|
| Email |
ajishababup96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of shalakya tantra Faculty of ayurveda
Banaras Hindu University
Varanasi
Uttarpradesh
India
221005
|
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Varanasi
Uttarpradesh
India
221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ajisha P |
Institute of science |
Department of Zoology,
Institute of Science
Banaras Hindu University
Varanasi
UTTAR PRADESH |
8606117260
ajishababup96@gmail.com |
| Ajisha P |
Sir sunderlal hospital |
OPD of shalakya tantra,
Faculty of ayurveda,
Institute of Medical science,
Banaras Hindu University
Varanasi
UTTAR PRADESH |
8606117260
ajishababup96@gmail.com |
| Ajisha P |
Sir sunderlal hospital |
OPD of ophthalmology, RIO, Institute of Medical Science, Banaras Hindu University
Varanasi
UTTAR PRADESH |
8606117260
ajishababup96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe, IMS, BHU |
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 | - | AScyotanam, आश्च्योतनम् | (Procedure Reference: Ashtanga hridaya sutrasthana , Procedure details: 1 drop of drug is to be instilled into lower fornix 3 times daily)
(1) Medicine Name: Draksha ghrita, Reference: Ashtanga Hridaya Uttarasthana (1/9), Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: tds, Duration: 30 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Carboxymethyl cellulose 0.5% eye drops | Carboxymethyl cellulose 0.5% eye drops: 1 drop, 4 times/day | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Carboxymethyl cellulose 0.5% eye drops, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 30 Days, Reference: NA, Route: -, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Signed ICF (Informed Consent Form)
Patients presenting with signs and symptoms of Dry eye Disease
Age group 18-50 years
TFBUT (Tear Film Break-up Time)less than or equal to 10 Seconds.
CFS (Corneal Fluorescein Staining)
Schirmer’s test less than 10mm |
|
| ExclusionCriteria |
| Details |
Cases with any ocular history even in one eye, ocular injury, ocular infection,
eyelid disease, lid abnormalities
Known allergies
Autoimmune disease
Patients who use contact lens
Other oral steroids, oral cyclosporine, anti glaucoma medication within 60 days before
screening
Patients suffering from any systemic disorder or taking any medications
History of ocular surgery within 6 months prior to enrolment
Stevens-Johnson syndrome
Sjogren’s syndrome
Patient who starts developing complications will be excluded from the study
Patient not willing for the treatment |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in OSDI score from baseline
|
30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Tear film breakup time from baseline
|
30 days |
Change in Tear film proteomics from baseline
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
11/06/2026 |
| 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="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
|
DED is a multifactorial disease of the ocular surface
characterized by a loss of homeostasis of the tear film, and accompanied by
ocular symptoms, in which tear film instability and hyperosmolarity, ocular
surface inflammation and damage, and neurosensory abnormalities play
etiological roles.
Treatment of DED typically involves various approaches such
as ophthalmic anti-inflammatory agents, autologous serum tears, punctal
occlusion, eye side shields, systemic cholinergic agents, incorporating
essential fatty acids, and adopting environmental strategies. Additionally
managing DED requires lifelong treatment as there is no curative remedy
available in conventional medicine, only palliative measures. The primary focus
for the management of DED lies in addressing the relentless inflammatory cycle.
However, the use of topical steroids for a long period can be harmful because
of adverse effects associated with it.
Ayurvedic drugs have been in use for centuries and have the
potential to be effective on multifactorial interlinked complex pathology. It
describes several medical formulations and topical therapeutic procedures to treat DED efficiently. Aschyotana is considered the
first and foremost ocular therapeutic procedure for all type of eye diseases.
This study will compare the changes in signs and symptoms of
Dry Eye Disease between the intervention and the control groups and also
compare the changes in human tear proteomes between both groups following
Draksha Ghrita eyedrop for 1month and assess treatment effectiveness at the
protein level according to treatment regimen.
Draksha contain polyphenols have ocular protective
activities like anti oxidant, antimicrobial, anti aging and anti inflammatory
properties. Purana Ghrita is having anti-oxidant, rejuvenating, wound healing
properties. Forms a uniform layer over ocular surface which bring a smoothening
effect to eyes. So overall effects of Draksha Ghrita can prevent the ocular
surface inflammation, tear film instability associated with dry eye disease and
can bring the normal ocular surface homeostasis.
|