| CTRI Number |
CTRI/2025/08/092687 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| 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
|
Comparing Ayurvedic Haridradi siddha milk eye wash and anu taila nasal drop with Standard Treatments for Dry Eyes Caused by Meibomian Gland Dysfunction A Randomized Clinical Trial |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Haridradi Siddha Paya Parishek with Anu Tail Marsha Nasya versus Standard Treatment Protocol in the Management of Meibomian Gland Dysfunction (Shushkakshipaka): Randomized Clinical Trial |
| 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 Prajwal Dilip Piprewar |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurvedic College and Research Centre Salod Wardha |
| Address |
Room No 24 Shalakyatantra Department Mahatma Gandhi Ayurvedic College Hospital and Reasearch Centre Salod Wardha Maharastra India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
09511813702 |
| Fax |
|
| Email |
piprewarp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roshana Rathi |
| Designation |
Professor Shalakyatantra Department |
| Affiliation |
Mahatma Gandhi Ayurvedic College and Research Centre Salod Wardha |
| Address |
Room No 24 Shalakyatantra Department Mahatma Gandhi Ayurvedic College Hospital and Reasearch Centre Salod Wardha Maharastra India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8766866422 |
| Fax |
|
| Email |
roshana.bhutada@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roshana Rathi |
| Designation |
Professor Shalakyatantra Department |
| Affiliation |
Mahatma Gandhi Ayurvedic College and Research Centre Salod Wardha |
| Address |
Room No 24 Shalakyatantra Department Mahatma Gandhi Ayurvedic College Hospital and Reasearch Centre Salod Wardha Maharastra India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8766866422 |
| Fax |
|
| Email |
roshana.bhutada@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurvedic College Hospital and Reasearch Centre Salod Wardha Maharastra India 442001e |
|
|
Primary Sponsor
|
| Name |
Dr Prajwal Dilip Piprewar |
| Address |
Mahatma Gandhi Ayurvedic College Hospital and Reasearch Centre Salod Wardha Maharastra India 442001 |
| 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 Roshana Rathi |
Mahatma Gandhi Ayurvedic College and Reasearch Centre Salod Wardha |
Room no 24 Shalakyatantra Department Mahatma Gandhi Ayurvedic College and Reasearch Centre Salod Wardha Maharashtra India 442001
Wardha
MAHARASHTRA |
8766866422
roshana.bhutada@dmiher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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) | Drug | Classical | | (1) Medicine Name: 1 Percent Azithromycin Eye Drop Drop , Reference: Arita R, Fukuoka S. Efficacy of Azithromycin Eyedrops for Individuals With Meibomian Gland Dysfunction-Associated Posterior Blepharitis. Eye Contact Lens. 2021 Jan 1;47(1):54-59. doi: 10.1097/ICL0000000000000729., Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 0.05(ml), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: 1 Percent Carboxymethylcellulose
Eye Drop 0.05 ml QID for 15 days | | 2 | Comparator Arm (Non Ayurveda) | Drug | - | | | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haridradi Siddha Paya Parishek, Reference: Sushruta Uttartantra 3/9, Route: Topical, Dosage Form: Ksheerpaka, Dose: 300(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Anu tail Nasya 6 drops OD for 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 18 years to 60 years will be selected irrespective of their gender caste religion
socio-economic or educational status
Patient suffering from Dry Eye Syndrome
Patients with Myopia and Hypermetropia will be selected
Patients with anatomically normal ocular structures will be selected
Patients who are ready to accept the treatment will be selected Written Consent |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in clinical symptoms of Shushkakshipaka
dryness irritation itching photophobia Tear Film Break-Up Time
|
Day 0 (Baseline)
Day 15 (Mid-treatment Follow-up)
Day 30 (Final Assessment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improvement in Meibomian Gland Expression Test
Schirmer’s Test
Meibography
Microscopic Swab Culture |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
18/09/2025 |
| 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="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [piprewarp@gmail.com].
- For how long will this data be available start date provided 01-11-2026 and end date provided 31-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study titled Evaluation of comparative efficacy of Haridradi Siddha Paya Parishek with Anu Tail Marsha Nasya versus Standard Treatment Protocol in the Management of Meibomian Gland Dysfunction Shushkakshipaka is a randomized clinical trial conducted to assess Ayurvedic interventions for Dry Eye Syndrome It compares the therapeutic effects of traditional Ayurvedic treatments Haridradi Siddha Paya Parisheka and Anu Tail Nasya with conventional allopathic methods The trial involves 54 patients divided into two groups and measures outcomes like tear film stability gland function and symptom relief. The aim is to validate Ayurvedic methods as cost-effective holistic alternatives for managing Meibomian Gland Dysfunction Results may encourage the integration of Ayurveda into routine ophthalmic care |