| CTRI Number |
CTRI/2025/05/086533 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparitive Clinical Study To Compare The Efficacy Of Karpooradikuzhambu Ointment And Triphaladi Rasakriya Ointment In The Management Of Blepharitis |
|
Scientific Title of Study
|
An Open Label Double Arm Randomised Clinical Study To Compare The Efficacy Of Karpooradhi Kuzhampu Pratisarana And Triphaladhi Rasakriya Pratisarana In The Management Of Krimigranthi Wsr To 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 |
Dr Priyana T V |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Kalabhyraveswara swamy ayurvedic medical college |
| Address |
Room number 21
Department of Shalakya Tantra
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Center Vijayanagar
Banglore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
8075728823 |
| Fax |
|
| Email |
priyanatv98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujathamma K |
| Designation |
Professor |
| Affiliation |
sri kalabhyraveswara swamy ayurvedic medical college |
| Address |
Room Number 21 Department Of Shalakya Tantra
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
944884786 |
| Fax |
|
| Email |
sujathamma0531@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSujathamma K |
| Designation |
PROFESSOR |
| Affiliation |
sri kalabhyraveswara swamy ayurvedic medical college |
| Address |
Room number 21
Department of Shalakya tantra Sri kalabyraveshwara swamy ayurvedic medical college hospital and research centre vijayanagar Bangalore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
944884786 |
| Fax |
|
| Email |
sujathamma0531@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri kalabyraveshwara swamy ayurvedic medical college hospital and research centre
vijayanagar bangalore 560104 |
|
|
Primary Sponsor
|
| Name |
Dr Priyana tv |
| Address |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| nil |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr kiran m goud |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre |
Department Of Shalakya Tantra Room Number 21
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| skamc and rc |
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 | Intervention Arm | Procedure | - | pratisAraNam, प्रतिसारणम् | (Procedure Reference: sushrutha samhitha, Procedure details: take quantity sufficient medicine & rub on the eye lids.)
(1) Medicine Name: karpooradi kuzhambu, Reference: sahasrayogam, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | pratisAraNam, प्रतिसारणम् | (Procedure Reference: sushrutha, Procedure details: take quantity sufficient medicine & rub on the eye lids.)
(1) Medicine Name: triphaladi rasakriya, Reference: bhaishajya ratnavali, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with the clinical features of krimigranthi
Patients presenting with signs and symptoms of blepharitis
Patients both gender within the age group of 20 to 60 years
|
|
| ExclusionCriteria |
| Details |
Associated with psoriasis and any other skin diseases
Posterior Blepharitis
Patients with systemic disorders that may interfere with the course of the study
Patients suffering with complictions of advanced stage Blepharitis such as Blepharokeratoconjuctivitis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To check the Reduction of Itching and Crusting Of eyelashes Watering of eyes Inflammation of
eyelids by slit lamp examination and other parameters in two treatment modalities viz Tripahala
rasakriya pratisarana and karpooradhi kuzhampu in krimigranthi w s r to blepheritis |
Total duration of study is 14 days 7days of pratisarana and 7 days of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
28/05/2025 |
| 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="6"
Days="5" |
|
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
|
Hence the present study will be undertaken to evaluate and compare the efficacy of karpooradi kuzhampu pratisarana and triphaladi pratisarana in krimigranthi wsr to blepharitis |