| CTRI Number |
CTRI/2024/06/068293 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| 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
|
To study the efficacy of vachadi bidalaka in the management of krimigranthi w. s.r to ulcerative blepharitis |
|
Scientific Title of Study
|
Randomised controlled clinical trial of efficacy of vachadi bidalaka in the management of krimigranthi w. s. r to ulcerative blepharitis . |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yogita Sahebrao Tupe |
| Designation |
PG Scholar |
| Affiliation |
Sangam Sevabhavi Trust ayurved mahavidyalaya graduate and research centre |
| Address |
Shalakya tantra department,Sangam Sevabhavi Trusts Ayurvedic Mahavidyalaya & Graduate OPP To Prasad Hotel Pune Nashik Highway Ghulewadi,Sangamner Ahmednagar, maharashtra
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9076306308 |
| Fax |
|
| Email |
satputedryogita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VD Rekha Jori |
| Designation |
Assitant proffesor |
| Affiliation |
Sangam sevabhavi trust ayurved mahavidyalaya graduate and research centre sangamner |
| Address |
Shalakya tantra department,Sangam sevabhavi trust ayurved mahavidyalaya graduate and research centre, opp prasad hotel pune nashik highway ghulewadi, sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9503197787 |
| Fax |
|
| Email |
drrekhamatkar1912@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogita Sahebrao Tupe |
| Designation |
PG Scholar |
| Affiliation |
Sangam Sevabhavi Trust ayurved mahavidyalaya graduate and research centre |
| Address |
Shalakya tantra department,Sangam sevabhavi trust ayurved mahavidyalaya graduate and research centre, opp prasad hotel pune nashik highway, sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9076306308 |
| Fax |
|
| Email |
satputedryogita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sangam sevabhavi trust graduate research centre, sangamner,district-Ahmednagar, country-India, Pincode- 422605. |
|
|
Primary Sponsor
|
| Name |
Sangam sevabhavi trust ayurved mahavidyalaya graduate and research centre sangamner |
| Address |
Sangam sevabhavi trust ayurved mahavidyalaya graduate and research centre.OPP prasad hotel pune nashik road ghulewadi ,sangamner country-India, pincode-422605 |
| Type of Sponsor |
Private medical college |
|
|
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 Yogita Sahebrao Tupe |
Ayurveda Mahavidyalaya Graduate & Research Centre |
OPD and IPD of shalakya tantra department of ayurveda mahavidyalaya graduate and research centre
Ahmadnagar
MAHARASHTRA |
9076306308
satputedryogita@gmail.com |
|
|
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:H010||Blepharitis. Ayurveda Condition: KRUMIGRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | biDAlaka:, बिडालक: | (Procedure Reference: Sharangdhara samhita, Procedure details: Lepa is done on the eyelids excluding eyelashes. )
(1) Medicine Name: Shigru nimba, Reference: Bhavprakash, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: od, Duration: 4 Weeks | | 2 | Intervention Arm | Procedure | - | biDAlaka:, बिडालक: | (Procedure Reference: Sharangdhara samhita, Procedure details: Lepa is done on the eyelids excluding eyelashes. )
(1) Medicine Name: Vacha-haridra-nimba, Reference: Sharangdhara, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: od, Duration: 4 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient willing to sign written consent
2)Patients with diagnostic symptoms of krimigranthi like strava kandu tod aarati krimiuttapati daha and symptoms of ulcerative blepharitis like itching soarness discharge from eye, eye foreign body sensation will be selected
3) Irrespective of religion and occupation. |
|
| ExclusionCriteria |
| Details |
1)Patient suffering from specific eyelid disorders like K/C/O TUMOUR CARCINOMA ECTROPION TRICHIASIS LAGOPTHALAMUS ACUTE OR CHRONIC INFECTIVE CONJUCTIVITIS CORNEAL ULCER ETC
2)Patient suffering from systemic disorder like K/C/O DM AND BLEEDING DISORDER.
3)The patient showing signs and symptoms of gradation score below 18 and above 50 age of Ulcerative blepharitis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)The Efficacy Of Vachadi Bidalaka In The Management Of Krimigranthi w.s.r to Ulcerative Blepharitis.
2)The efficacy will be assessed by observing the effect on the subjective parameters (itching, pain, burning sensation, foreign body sensation ) |
4week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Review of etiological factors of krimigranthi.
2)The efficacy of vachadi bidalaka & shigru nimba bidalaka in the management of krimigranthi wsr to ulcerative blepharitis.
3)Review of procedure of bidalaka in detail.
4) The effect on subjective parameters like itching, burning sensation, pain, foreign body sensation will be assessed. |
Every week for a month. |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/06/2024 |
| 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="6"
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
|
Eye is an vital Organ Which If Diseased Hampers day to day life . Blepharitis Is Mainly Caused Due To Low Hygeine .It is a Chronic Disease And Its Recurrence Occurs . Bidalaka Procedure Is Best In Symptoms of Daha , Updeha,Asru ,Shopha ,Raga Of Eye Disease . Vachadi Bidalaka Consists Vacha ,Haridra And Neem. Vacha has vedanahara property .Haridra is Shothahara,Vedanasthapan and Kandughana,Vranashodhana and Vranaropan and krimi prakruti vighatakar property . Nimba has Puyasravaghana, Krimighna property. Bidalaka is Easy Procedure Used ,It Is locally Fast acting Procedures So That Patient Is Relieved Fast. All Dravyas Are Economical And Easily Available. |