| CTRI Number |
CTRI/2025/01/079624 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| 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
|
A clinical trial to study application of medicated paste on eyelid for eyelids inflammation |
|
Scientific Title of Study
|
A randomized controlled clinical study of shunthyadi pindi in blepharities |
| 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 Chand Babu Siddiqui |
| Designation |
MS Shalakya scholar |
| Affiliation |
Bharati Vidyapeeth deemed to be university,college of ayurved and hospital |
| Address |
Bharati Vidyapeeth (Deemed to be University)College of Ayurved and Hospital Department of Shalakya TantraOPD number 24 Dhankawadi Pune
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Shalakya Tantra OPD number 24 Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9130714165 |
| Fax |
|
| Email |
Chandbabu.siddiqui-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gajanan Balkrishna Patil |
| Designation |
Associate Professor MS shalakya |
| Affiliation |
Bharati Vidyapeeth deemed to be university college of ayurved |
| Address |
Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital Department of Shalakya Tantra OPD number 24DhankawadiPune
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Shalakya Tantra OPD number 24DhankawadiPune
Pune
MAHARASHTRA
411043
India |
| Phone |
9923037117 |
| Fax |
|
| Email |
Patil.gajanan1@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gajanan Balkrishna Patil |
| Designation |
Associate Professor MS shalakya |
| Affiliation |
Bharati Vidyapeeth deemed to be university college of ayurved |
| Address |
Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital Department of Shalakya Tantra OPD number 24DhankawadiPune
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Shalakya Tantra OPD number 24DhankawadiPune
Pune
MAHARASHTRA
411043
India |
| Phone |
9923037117 |
| Fax |
|
| Email |
Patil.gajanan1@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Department of Shalakya Tantra, College of Ayurved and Hospital, Bharati Vidyapeeth (Deemed to be University),
Katraj Dhankawadi Campus, Pune 411043 |
|
|
Primary Sponsor
|
| Name |
Dr chand babu Siddiqui |
| Address |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital Department of
Shalakyatantra,OPD No.-24
Katraj Dhankawadi Pune 411043 |
| 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 chand babu siddiqui |
Bharati ayurved hospital |
OPD No. 24 Department of Shalakya Tantra
Pune
MAHARASHTRA |
9130714165
Chandbabu.siddiqui-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE [BV(DU)COA-EC] |
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: Shunthyadi PiNDI, Procedure details: PiNDI of Shunthyadi churna applied on affected eye 10mins per day for 10 days)
(1) Medicine Name: Shunthyadi , Reference: Chakra Datta , Route: Ocular, Dosage Form: Churna/ Powder, Dose: 30(g), Frequency: od, Duration: 10 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | CHLORAMPHENICOL (1% W/W) | CHLORAMPHENICOL EYE OINTMENT local application on lid margin for 10 days once a time daily on bed time only. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants presenting with symptoms of Blepharitis who are willing to participate will be selected
Participants between the age group of 18 to 60 years will be included
Participants will be selected irrespective of gender
socioeconomic status and religion |
|
| ExclusionCriteria |
| Details |
Patients suffering from other ocular pathologies
Patients suffering from any lash abnormalities such as madarosis (absenceof cilia) poliosis Trichiasis etc
Patients having Eczema of skin & recurrent stye
One eye |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced lid margins oedema and pain |
1, 3, 5, 7, 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced itching, watering & scaling of lid margin. |
1,3,5,7,10 days |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
10/02/2025 |
| 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 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 a randomised, controlled, open label, parallel group study on effect of Shunthyadi pindi in blepharities for 7 days in 21 patients with that will be conducted in Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital, Department of Shalakya Tantra, OPD number 24, Katraj, Dhankawadi, Pune Primary Outcome – reduction in lid margins oedema and pain in the trial group. Secondary outcome - Reduction in the symptoms of itching, watering and scaling in the |