| CTRI Number |
CTRI/2025/04/084872 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see the effect of Shunthi Gairik Lepa in treatment of Anjananamika. |
|
Scientific Title of Study
|
Single arm clinical trial to assess the efficacy of Shunthi Gairik Lepa in Anjananamika w.s.r. To Stye. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saurabh Ishwar Bhandari |
| Designation |
PG SCHOLAR |
| Affiliation |
SST Ayurved College |
| Address |
Shalakyatantra OPD, Ground floor, Shalakya department,SST Ayurved College Nashik Pune Highway Opp Prasad cafe Ghulewadi Sangamner Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9689979941 |
| Fax |
|
| Email |
bsaurabh333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anil Sugandharao Deshmukh |
| Designation |
HOD Shalakyatantra Department |
| Affiliation |
SST Ayurved College |
| Address |
Shalakatantra OPD
Ground floor
Shalakyatantra Department
SST Ayurved College
Nashik Pune Highway
Opp Prasad cafe
Ghulewadi Sangamner Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9822262627 |
| Fax |
|
| Email |
ranwaraanil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saurabh Ishwar Bhandari |
| Designation |
PG SCHOLAR |
| Affiliation |
SST Ayurved College |
| Address |
Shalakyatantra OPD
Ground Floor
Shalakyatantra Department
SST Ayurved College
Nashik Pune Highway
Opp Prasad cafe
Ghulewadi Sangamner Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9689979941 |
| Fax |
|
| Email |
bsaurabh333@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalakyatantra OPD, ground floor, SST Ayurved College, opp Prasad Cafe, Ghulewadi, Sangamner, Ahmednagar,Maharashtra, India 422605 |
|
|
Primary Sponsor
|
| Name |
No |
| Address |
No |
| Type of Sponsor |
Other [] |
|
|
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 |
| Saurabh Ishwar Bhandari |
SST Ayurved College |
Shalakyatantra OPD,Shalakyatantra department, ground floor, SST Ayurved College Nashik Pune Highway Opp Prasad Cafe Ghulewadi Sangamner
Ahmadnagar
MAHARASHTRA |
9689979941
bsaurabh333@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:H000||Hordeolum (externum) (internum) ofeyelid. Ayurveda Condition: ANJANANAMIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharagadhara Samhita Uttartantra / Lepa Adhyay / Shloka 1-2, Procedure details: Patient is lie down in supine position & made to close his/her eyelids. Shunthi-Gairika Lepa will be applied on the affected eyelid till it starts to dry. Thickness of Lepa should be around 1/4th Angula Praman as per mentioned in Sharangdhara Samhita.)
(1) Medicine Name: Shunthi, Reference: Sharagdhara Samhita Uttartantra / Adhyay 13 / Shloka 32-33, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 5 Days(2) Medicine Name: Gairika, Reference: Sharangdhara Samhita Uttartantra / Adhyay 13 / Shloka 32-33, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age From 18 year to 60 year
2. Both Male and Female Gender
3. Sign And Symptoms of Anjananamika in Apakva Avastha like Vartmashotha, Vedana, Araktata, kandu, Daha
4. sign and symptom of stye like localised, firm, red, tender swelling at eyelid margin, edema at eyelid margin. |
|
| ExclusionCriteria |
| Details |
1) Utsangi pitika, pakva, panchaman Avastha.
2) Pregnant & lactating mothers.
3) K/C/O DM, HTN, TB, anemia, any systemic illness and malignancy.
4) Known cases of congenital disorders of eyelid like Congenital ptosis, congenital coloboma, Epicanthus, Distichiasis, Cryptophthalmos, Microblepharon, Epiblepharon, Euryblepharon. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Shunthi-Gairik Lepa in Anjananamika w.s.r. Stye. |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To review concept of Anjananamika |
5 days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/04/2025 |
| 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="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
|
It is a single arm clinical trial to evaluate the efficacy of Shunthi Gairik Lepa in the management of Anjananamika w.s.t. Stye in the age group of 18 to 60 years of males and females |