| CTRI Number |
CTRI/2025/03/082813 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| 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
|
Role of Pathyadi Varti Anjana in Meibomian Gland Dysfunction and Associated Dry Eye |
|
Scientific Title of Study
|
Evaluation of Treatment Efficacy, Safety and Tolerability of an Ayurvedic Ophthalmic Ointment (Pathyadi Varti Anjana) for Meibomian Gland Dysfunction and Associated Dry Eye: A Pilot Clinical Study |
| 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 Rajiv Ranjan Mishra |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic College and Hospital, Patna |
| Address |
Government Ayurvedic College and Hospital, Kadamkuan, Patna,
Bihar, India
Department of Shalakya Tantra, Government Ayurvedic College and
Hospital, Kadamkuan, Patna, Bihar, India
Patna
BIHAR
800003
India |
| Phone |
9717223122 |
| Fax |
|
| Email |
rajiv.mishra1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruby Kumar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College and Hospital, Patna |
| Address |
Department of Shalakya Tantra, Government Ayurvedic College and Hospital, Patna
Patna
BIHAR
800003
India |
| Phone |
8210002352 |
| Fax |
|
| Email |
dr.rubybhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Rajiv Ranjan Mishra |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic College and Hospital, Patna |
| Address |
Department of Shalakya Tantra, Government Ayurvedic College and Hospital, Patna
Patna
BIHAR
800003
India |
| Phone |
9717223122 |
| Fax |
|
| Email |
rajiv.mishra1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment ayurvedic college and hospital,Kadamkuan, Patna, Bihar- 800003, India |
|
|
Primary Sponsor
|
| Name |
Dr. Rajiv Ranjan Mishra |
| Address |
Department of Shalakya Tantra, OPD - Room No.2, Goverment
Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Rajiv Ranjan Mishra |
Goverment Ayurvedic College and Hospital, Patna |
Room No.2, Shalakya-Netra Roga OPD
Patna
BIHAR |
9717223122
rajiv.mishra1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H028||Other specified disorders of eyelid. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Moxifloxacin eye ointment (0.5%) | Moxifloxacin eye ointment (0.5%) – once a day before bathing. | | 2 | Intervention Arm | Procedure | - | a~jjanam, अंजनम् | (Procedure Reference: Sushruta Uttartantra, Chapter 18, Procedure details: Pathyadi varti Anjana – once a day before bathing.)
(1) Medicine Name: Pathyadi Varti, Reference: Sushruta Uttartantra, Chapter 18, Verse 105-106, Route: Ocular, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(NA), Frequency: od, Duration: 2 Months |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who meet the following criteria will be selected for the study
1) Adult patients (aged 18 years or older) with a diagnosis of Meibomian Gland Dysfunction (MGD), ocular dryness, meibomian gland orifice plugging, lid margin telangiectasia.
2) Patients with MGD having Ocular Surface Disease Index (OSDI) scores of more than or equal to 13 at baseline and tear film breakup time (TBUT) of less than or equal to 10 seconds, Schirmer’s test less than or equal to 10mm in both eyes.
3) Score more than or equal to 6 on the Standard Patient Evaluation of Eye Dryness questionnaire (SPEED).
4) Prior to starting recruitment procedures, patients are required to have discontinued -
a) Use of systemic antihistamines or isotretinoin for at least 1 month.
b) Anti-inflammatory treatments for DED for at least 3 months.
c) All other prescription medications used for dry eye or MGD (e.g., antibiotics, corticosteroids, and non-steroidal anti-inflammatory) for at least 2 weeks.
d) All other topical ophthalmic preparations (including artificial tear substitutes) other than the study medication: 72 hours prior to screening visit.
5) Patients able and willing to provide written informed consent and likely to complete the entire course of study according to instructions.
|
|
| ExclusionCriteria |
| Details |
Patients will be excluded from enrollment if they have
1) With pre-existing diseases causing dry eye (e.g., autoimmune diseases such as Sjogren syndrome, rheumatoid arthritis, lupus, Graves’ disease, and sarcoidosis), ocular infection or inflammation including conjunctivitis, keratitis, episcleritis, scleritis, dacryocystitis; punctual occlusion; lagophthalmos; ocular trauma; Stevens-Johnson syndrome.
2) Inflammatory diseases unrelated to MGD.
3) Patients suffering from any systemic disorder or taking any medications which in the opinion of Principle Investigator may affect the clinical outcome of the trial.
4) Use of topical steroids, topical cyclosporine, topical anti-glaucoma medication within 60 days before screening.
5) History of Contact lenses use.
6) History of ocular surgery within 6 months prior to enrolment in trial.
7) Chemical, thermal or radiation injury.
8) Ocular or periocular malignancy.
9) Lid structural abnormality not caused by MGD.
10) An active or recurring eye or eyelid infection or ocular surface abrasion.
11) Only one eye in each patient will be enrolled in the study. If both eyes will be eligible, the right eye will be selected.
12) Patients who will unable to continue for the proposed length of treatment or return for follow-up visits.
13) Pregnant and lactating mother.
14) Active participation in any type of intervention study.
15) Patients who start developing complications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the mean change in Total Ocular Surface Disease Index (OSDI) at the follow-up and after 2 months (last treatment visit) compared with baseline. |
day 15, day 30, day 45, day 60, and day 75 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the mean change in tear break-up time (TBUT), Schirmer test and fluoresceine staining test at the follow-up and last treatment visits compared with baseline.
2. To determine the mean change from baseline to follow up and last treatment visit in Standard Patient Evaluation of Eye Dryness (SPEED) score and visual analog.
3. To determine the change in eyelid appearance (Normal versus Abnormal) in biomicroscopy evaluation with the slit lamp, including lid margin thickening, conjunctival injection, loss of eye lashes, pouting and plugging of meibomian gland orifices at the follow-up and last treatment visit compared with baseline.
4. To determine the tolerability and safety of Ayurvedic intervention (Pathyadi Varti Anjana).
|
day 15, day 30, day 45, day 60, and day 75 |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
02/04/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Purpose: To evaluate the treatment
efficacy, safety, and tolerability of Pathyadi Varti ointment applied to
the upper and lower eyelid once a day before bathing for up to 2 months
compared to Moxifloxacin eye ointment (0.5%) in patients with meibomian gland
dysfunction (MGD) and associated dry eye.
Design: Clinical, Prospective,
Randomized, Open labelled, Parallel Group, Drug controlled, Single
blind study.
Participants: (n=15) Patients of either gender,
aged 18 years or older, diagnosed with meibomian gland dysfunction based on
their medical history and eyelid examination. Severity grading will be
conducted on the screening day using the Ocular Surface Disease Index (OSDI),
the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and the
Visual Analogue Scale (VAS).
Methods: Patients will be randomized in a 1:1
ratio to study treatment with Trial drug (Pathyadi Varti) or Control
drug (Moxifloxacin Eye ointment 0.5%). Each enrolled subject will receive
treatment for 2 months and will be followed for a total of 2.5 months, with
evaluations conducted at baseline and on days 15, 30, 45, 60, and 75 after
starting the study medication. Only one eye per patient will be randomly
selected for evaluation, with preference given to the eye exhibiting a worse
Ocular Surface Disease Index (OSDI), Standard Patient Evaluation of Eye Dryness
(SPEED) score, and Visual Analogue Scale (VAS) score; if both eyes have equal
scores, the right eye will be chosen. Study participants will complete the OSDI
questionnaire, SPEED questionnaire, and VAS assessment at each visit. Tear
Break-Up Time (TBUT) will be performed first to avoid potential interference
from eyelid manipulation, with three successive readings averaged. Following a
30-minute wait, Schirmer’s test without anesthesia will be conducted with the
patient’s eyes closed. TBUT, Schirmer’s test, and corneal fluorescein staining
(CFS) will be performed at each visit.
Main outcome measures: The primary efficacy
outcome will be to determine the mean change in the Total Ocular Surface
Disease Index (OSDI) at follow-up and after 2 months (last treatment visit)
compared with baseline. The secondary efficacy outcome will be to determine the
mean change in tear break-up time (TBUT), Schirmer test, and fluorescein
staining test at follow-up and the last treatment visit compared with baseline.
Additionally, the mean change from baseline to follow-up and the last treatment
visit in the Standard Patient Evaluation of Eye Dryness (SPEED) score and
Visual Analogue Scale (VAS) will be assessed. Changes in eyelid appearance
(normal versus abnormal) will also be evaluated using biomicroscopy with a slit
lamp, including parameters such as lid margin thickening, conjunctival
injection, loss of eyelashes, pouting, and plugging of meibomian gland orifices
at follow-up and the last treatment visit compared with baseline. Furthermore,
the tolerability and safety of the Ayurvedic intervention (Pathyadi Varti
Anjana) will be assessed.
Results: Both groups will be compared on the
basis of main outcome measures. |