| CTRI Number |
CTRI/2025/03/081688 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the role of Shunthyadi Pindi kriyakalpa in management of Blepharitis(Praklinnavartma). |
|
Scientific Title of Study
|
Effectiveness of Shunthyadi Pindi in comparison with 1 percent Azithromycin eye ointment in management of Praklinnavartma (Blepharitis)- A Randomized control 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 Madhuri Pawar |
| Designation |
PG Scholar |
| Affiliation |
|
| Address |
YMT Ayurvedic Medical College and Hospital,Institutional Area, Sector 4, Kharghar, Navi Mumbai. Raigarh.410210
YMT Ayurvedic Medical College and Hospital,Institutional Area, Sector 4, Kharghar, Navi Mumbai. Raigarh.410210.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9764200602 |
| Fax |
|
| Email |
vaidyamadhuri46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Magar |
| Designation |
Professor |
| Affiliation |
YMT Ayurvedic Medical College and Hospital, Sector 4, Kharghar, Navi Mumbai. Raigarh. |
| Address |
YMT Ayurvedic Medical College and Hospital, Shalakya Tantra Department, Ground Floor, Institutional Area, Sector 4, Kharghar, Navi Mumbai. Raigarh.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9987335024 |
| Fax |
|
| Email |
sunitamagar66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Magar |
| Designation |
Professor |
| Affiliation |
YMT Ayurvedic Medical College and Hospital, Sector 4, Kharghar, Navi Mumbai. Raigarh. |
| Address |
YMT Ayurvedic Medical College and Hospital, Shalakya Tantra Department, Ground Floor, Institutional Area, Sector 4, Kharghar, Navi Mumbai. Raigarh.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9987335024 |
| Fax |
|
| Email |
sunitamagar66@gmail.com |
|
|
Source of Monetary or Material Support
|
| YMT Ayurvedic Medical College and Hospital, Shalakya tantra department,OPD and IPD,Kharghar, Navi Mumbai, Raigarh. Maharashtra. India.
Pin code- 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Madhuri Pawar |
| Address |
YMT Ayurvedic Medical College and Hospital,Institutional Area, Sector 4, Kharghar, Navi Mumbai. Raigarh.410210 |
| 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 Madhuri Pawar |
YMT Ayurvedic Medical College and Hospital. |
OPD and IPD Of Shalakya Tantra Department, YMT Ayurvedic Medical College and Hospital, Ground Floor, Institutional Area, Sector 4, Kharghar, Navi Mumbai. Raigarh.
Raigarh
MAHARASHTRA |
9764200602
vaidyamadhuri46@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:H010||Blepharitis. Ayurveda Condition: PRAKLINNAVARTMA/KAPOTKLISHTA-VARTMA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | piNDI, पिण्डी | (Procedure Reference: sharangdhra samhita madhyam khanda netraog chikitsa prakarnam 25 , Procedure details: churna of the expected dravya is taken in sterile bowl & mixed with warm water to get thick kalka which is rolled in sterile gauze piece
this pindi is now kept on closed eye for 15 min & after that patient is asked to wash face with warm water)
| | 2 | Comparator Arm (Non Ayurveda) | | - | 1 percent Azithromycin eye ointment | 1 percent Azithromycin eye ointment given for 14 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients in age group of 18-40 years and irrespective of
gender.
2. Patient of Praklinnavartma diagnosed by Ayurveda classics -
1. Aruja bhayahata shun
2.Antahaklinnata
3.Strav
4.Kandu
5.Nistod |
|
| ExclusionCriteria |
| Details |
Patient having major eye problem like corneal ulcer, entropion
etc.
2. Patient with any malignant condition of eye.
3. Patient who has undergone Punctum occlusion surgery.
4. Patient with skin diseases like psoriasis, rosacea, atopic
dermatitis,
5. Patient with uncorrected refractive error.
6. Patient suffering with complications of Blepharitis such as
conjunctivitis & Keratitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Shunthyadi pindi in reducing the symptoms aruja bhahyatahashun, nistod, kandu, strav by slit lamp examination and schirmers test in management of symptoms of Praklinnavartma (Blepharitis) |
follow up on 0th,7th,14th,28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in matting of eyelashes, marginal hyperemia and schirmers test. |
follow up on 0th, 7th, 14th and 28th day. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
14/03/2025 |
| 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="2"
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 - NO
|
|
Brief Summary
|
Aim- To assess the effectiveness of Shunthyadi pindi in comparison with 1% Azithromycin eye ointment in management of Praklinnavartma(Blepharitis)
Primary Objective- To study the effectiveness of Shunthyadi Pindi in comparison with 1% Azithromycin eye ointment in reducing the symptoms of Aruja bhayahatashun, Antahaklinnata, Strav, Knadu, Nistod in management of Praklinnavartma(Blepharitis).
Secondary Objective- To assess the changes in matting of eyelashes, marginal hyperemia and schirmer’s test. |