| CTRI Number |
CTRI/2025/04/085529 [Registered on: 24/04/2025] 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 Comparative Clinical Study Of Collyrium Of Kusumika And Nilotpaladya Along with Triphala Powder in Cataract |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Kusumika Varti Anjana And Nilotpaladya Varti Anjana Along With Triphala Churna In The Management Of Prathama Patalagata Timira Wsr To Lamellar Separation Stage Of Senile Cortical Cataract |
| 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 Rachana K |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Kalabyraweshwara Swamy Ayurvedic Medical College Hospital And Research Centre |
| Address |
Department Of Shalakya Tantra Room No 21 Sri Kalabyraweshwara Swamy Ayurvedic Medical College Hospital And Research Centre No 10 Pipeline Road Rpc Layout Vijayanagar 2nd Stage
Bangalore
KARNATAKA
560104
India |
| Phone |
8861107842 |
| Fax |
|
| Email |
rachanagudgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujathamma K |
| Designation |
Professor And Hod |
| Affiliation |
Sri Kalabyraweshwara Swamy Ayurvedic Medical College Hospital And Research Centre |
| Address |
Room No 21 Department Of Pg Studies In Shalakya Tantra Sri Kalabyraweshwara Swamy Ayurvedic Medical College Hospital And Research Centre
No 10 Pipeline Road Rpc Layout Vijayanagar 2nd Stage
Bangalore
KARNATAKA
560104
India |
| Phone |
9448848786 |
| Fax |
|
| Email |
drsujathammaskamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujathamma K |
| Designation |
Professor And Hod |
| Affiliation |
Sri Kalabyraweshwara Swamy Ayurvedic Medical College Hospital And Research Centre |
| Address |
Room No 21 Department Of Pg Studies In Shalakya Tantra Sri Kalabyraweshwara Swamy Ayurvedic Medical College Hospital And Research Centre
No 10 Pipeline Road Rpc Layout Vijayanagar 2nd Stage
KARNATAKA
560104
India |
| Phone |
9448848786 |
| Fax |
|
| Email |
drsujathammaskamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rachana K Room No 21 Dept Of Pg Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical
College Hospital And Reseach Centre Vijayanagar Bangalore karnataka India 560104 |
|
|
Primary Sponsor
|
| Name |
Dr Rachana K |
| Address |
Room No 21 Department Of Pg Studies In Shalakya Tantra Sri Kalabyraweshwara Swamy Ayurvedic Medical College Hospital And Research Centre No 10 Pipeline Road Rpc Layout Vijayanagar 2nd Stage |
| 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 Kiran M Goud |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
Room No 21 Department Of Pg Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy
Ayurvedic Medical College
Hospital And Research Centre
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCH AND RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H250||Age-related incipient cataract. Ayurveda Condition: PRATHAMA PATALAGATA TIMIRA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | a~jjanam, अंजनम् | (Procedure Reference: Chakrapanidatta Chikitsa Sangraha, Procedure details: 1 harenu matra of nilotpaladya anjana mixed with honey should be taken in fingertip of right hand & applied uniformly from kaneenika sandhi to apanga sandhi once in morning)
(1) Medicine Name: Triphala churna, Reference: Bhavaprakasha Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Duration: 48 Days | | 2 | Comparator Arm | Procedure | - | a~jjanam, अंजनम् | (Procedure Reference: gadanigraha, Procedure details: 1 harenu matra of kusumika varti anjana mixed with honey should be taken in fingertip of right hand & applied uniformly from kaneenika sandhi to apanga sandhi once in morning)
(1) Medicine Name: Triphala churna, Reference: Bhavaprakasha nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Duration: 48 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects With Lakshanas Of Prathamapatalagata Timira
Subjects With Clinical Features Of Lamellar Separation Stage Of Senile Cortical Cataract
Subjects Within The Age Group Of 40 To 60 Years Irrespective Of Gender
• Subjects who are fit for Anjanaprocedure.
|
|
| ExclusionCriteria |
| Details |
Subjects With Complicated Cataract Congenital Cataract Secondary Cataract And Traumatic Cataract And Requiring Surgical Intervention
Subjects With Mature Cataract
Subjects With Corneal Diseases Retinal Diseases Sclera And Conjunctival Abnormalities
Subjects With Other Systemic Diseases Which Interferes With The Course Of Treatment
|
|
|
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 See The Improvement In Visual Acuity And Decrease in vacuoles in the lens |
Total Duration Of Study Is 79 Days 48 Days Of Anjana And Triphala Churna In Both The Groups And Followup After 1Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
05/05/2025 |
| 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="0"
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
|
Thus
the present study is taken to scientifically validate and compare the effect of
KusumikavartiAnjana and
NilotpaladyaAnjana along
with Triphalachoorna in
the management of Prathamapatalagata timira w s r lamellar separation
stage of senile cortical cataract |