| CTRI Number |
CTRI/2025/02/080748 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Kriyakalpa ( Bidalaka)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effectiveness of ayurvedic preparation vachadi bidalaka and triphala guggulu in the treatment of disease lagan which is correlated with disease chalazion according to modern science. |
|
Scientific Title of Study
|
Randomized controlled clinical study on the efficacy of vachadi bidalaka and Triphala Guggulu in the management of Lagan with special reference to chalazion. |
| 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. Prachi Jivanlal Patle |
| Designation |
PG scholar Shalakyatantra Department. |
| Affiliation |
Vidarbha ayurved Mahavidyalaya |
| Address |
OPD no.13 Shalakyatantra Department GNT hospital And Vidarbha ayurved Mahavidyalaya Chhatri Talav road,Dastur nagar, Amravati.
Amravati
MAHARASHTRA
444605
India |
| Phone |
8208523616 |
| Fax |
|
| Email |
prachipatle98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jyoti R. Dakhore |
| Designation |
Guide and HOD Shalakyatantra Department |
| Affiliation |
Guide And HOD Shalakyatantra Department |
| Address |
OPD no.13 Shalakyatantra Department GNT hospital And Vidarbha ayurved Mahavidyalaya,Chhatri Talav road ,Dastur nagar, Amravati.
Amravati
MAHARASHTRA
444605
India |
| Phone |
9011727497 |
| Fax |
|
| Email |
jyotidakhore23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Prachi Jivanlal Patle |
| Designation |
PG scholar Shalakyatantra Department. |
| Affiliation |
PG Scholar |
| Address |
OPD no.13 Shalakyatantra Department GNT hospital And Vidarbha ayurved Mahavidyalaya,Chhatri Talav road,Dastur nagar, Amravati.
Amravati
MAHARASHTRA
444605
India |
| Phone |
8208523616 |
| Fax |
|
| Email |
prachipatle98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidarbha Ayurveda Mahavidyalaya and GNT Hospital ,Chhatri Talav road, Dastur nagar, Amravati 444605 |
|
|
Primary Sponsor
|
| Name |
Vidarbha Ayurved Mahavidyalaya, Amravati |
| Address |
Vidarbha Ayurved Mahavidyalaya, Chhatri Talav road, Dastur nagar Amravati,Maharashtra 444605. |
| 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 Prachi Jivanlal Patle |
Vidarbha Ayurveda Mahavidyalaya and GNT Hospital |
OPD no.13, Shalakyatantra Department GNT hospital And Vidarbha Ayurved Mahavidyalaya, Chhatri Talav road Dastur nagar Amravati.
Amravati
MAHARASHTRA |
8208523616
prachipatle98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vidarbha Ayurved Mahavidyalaya, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H001||Chalazion. Ayurveda Condition: LAGANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Chloromphenicol 1.0% eye ointment with tab Doxycycline 100mg | Chloromphenicol eye ointment 1.0% with tab.doxycyline 100mg
Chloromphenicol eye ointment External - Local Application at night
tab.doxycyline 100mg orally in 1 BD dose. | | 2 | Intervention Arm | Procedure | - | biDAlaka:, बिडालक: | (Procedure Reference: Sharangdhar Samhita Adhyay no.13, Procedure details: Bidalaka is apply over closed eyelid except eyelashes.
Matra-
Madhyam - 1/3 Angul thickness.
Pashchat karma - After Kalka is dry then remove it.)
(1) Medicine Name: Vacha Churna,Haridra Churna,Shunthi Churna, Reference: Bhavprakash Chikitsa Prakaran ,Madhya khand Netrarogadhikar., Route: Topical, Dosage Form: Kalka/ Paste, Dose: 10(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient of the age group 14-50 years.
Patient have mild to moderate size of chalazion.
Patient have sign and symptoms of lagan as per classical text |
|
| ExclusionCriteria |
| Details |
Patient below 14 year of age and above 50 year of age.
Patient with other associated occular disease dacryocystitis, corner ulcer, Pterygium.
Patient with other systemic disorders like diabetes, hypertension, Asthma. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Painless eyelid swelling, Watering of eyes, inflammation of eyelid, Reddish purple area in tarsal conjunctiva of the patient resolved completely |
0th day
7th day
15th day
30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Remission from all kind of lagan (chalazion)
Clear eyelid skin achieved |
15th day
30th day |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
01/03/2025 |
| 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="0"
Months="8"
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
|
A Randomised controlled clinical trial will be conducted to study the efficacy of vachadi bidalaka with Triphala guggulu and Chloramphenicol eye ointment 1.0% with tab doxycycline 100mg in Lagan with special reference to chalazion.
Trial will be conducted in our institute and it’s periphery.Total 96 patients diagnosed with chalazion. One group will be given Vachadi Bidalaka with Triphala guggulu and other group will be advised Chloramphenicol eye ointment 0.1% with tab doxycycline 100mg.
The study will be done for 30 days
Result will be compared between the two groups. Data analysis will be done by using appropriate statistical test. Primary outcomes will be to compare the effectiveness of Vachadi bidalaka with Triphala guggulu and Chloramphenicol eye ointment 0.1% with tab doxycycline 100mg in chalazion and complete, moderate or mild remission of chalazion in patients.
|