| CTRI Number |
CTRI/2024/07/069874 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Anjana in Immature Cortical Cataract |
|
Scientific Title of Study
|
An open label controlled clinical study on the efficacy of Vyoshadhi Varti Anjana in the management of Kaphaja Timira,Immature 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 Rethika |
| Designation |
Post Graduate Resident |
| Affiliation |
SDM Institute of Ayurveda and Hospital |
| Address |
Room no 11 Department of Shalakyatantra ,SDM Institute of Ayurveda and Hospital,Anchepalya,Bengaluru.
Bangalore
KARNATAKA
560074
India |
| Phone |
9488414879 |
| Fax |
|
| Email |
drrethika@sdmayurbangalore.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Stuvert |
| Designation |
Associate Professor |
| Affiliation |
SDM Institute of Ayurveda and Hospital |
| Address |
Room no : 11, Department of shalakya tantra,SDM Institute of Ayurveda and Hospital,Anchepalya,Bengaluru.
Bangalore
KARNATAKA
560074
India |
| Phone |
9481028050 |
| Fax |
|
| Email |
divyastuvert@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Stuvert |
| Designation |
Associate Professor |
| Affiliation |
SDM Institute of Ayurveda and Hospital |
| Address |
Room no : 11, Department of shalakya tantra,SDM Institute of Ayurveda and Hospital,Anchepalya,Bengaluru.
Bangalore
KARNATAKA
560074
India |
| Phone |
9481028050 |
| Fax |
|
| Email |
divyastuvert@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SDM Institute of Ayurveda and Hospital,Anchepalya,Bengaluru-560074. |
|
|
Primary Sponsor
|
| Name |
Dr.Rethika |
| Address |
SDM Institute of Ayurveda and Hospital Anchepalya Bengaluru-560074 |
| 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 |
| DrDivya Stuvert |
SDM Institute of Ayurveda and Hospital |
Room no 11 Department of Shalakyatantra, SDM Institute of Ayurveda and Hospital,Anchepalya,Bengaluru-560074
Bangalore
KARNATAKA |
9481028050
divyastuvert@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital |
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: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: Astangasangraha, Procedure details: Patient is advised to lie dow in supine position comfortably.
the eye lid & surrounding area is wiped with clean cotton.
Varti is rubbed with plain water to make it in paste consistency.
Patient is advised to open the eyes widely with help of left handlower eye lid id pulled down.
With help of anjana shalaka the medicine is applied over the lower lid.
Patient is advised to close the eyes and asked to rotate the eyeball for proper spreading of the medicine.
Once lacrimation stops patient is asked to wash the eyes with clean warm water.)
(1) Medicine Name: vyoshadhi varti , Reference: Bhaisajya rathnavali, Route: Topical, Dosage Form: Varti/ Suppository, Dose: 40(mg), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: Astanga sangraha , Procedure details: Patient is advised to lie down in supine position comfortably.
the eyelid & surrounding area is wiped with clean cotton.
Varti is rubbed with plain water to make it into paste consistency.
Patient is advised to open the eyes widely,with the help of left hand the lower eyelid is pulled down.
With help of anjana shalaka the medicine is applied over the lid.
Patient is advised to close the eyes and rotate the eyeball for spreading of the medicine.
Once the lacrimation stops patient is asked to clean the eyes with warm water.)
(1) Medicine Name: Harithakyadhi varti, Reference: Bhaisajya rathnavali, Route: Topical, Dosage Form: Varti/ Suppository, Dose: 40(mg), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with clinical features of Kaphaja Timira and cortical senile Immature cataract
2.Visual acuity distant 0.1 to 0.7 LogMAR
3.Near vision N8 to N36 |
|
| ExclusionCriteria |
| Details |
1. Patients with signs of nuclear sclerosis, polar cataract, posterior subcapsular cataract.
2. Patients with congenital cataract or developmental cataract or cataract caused due to any
systemic disorder.
3. Patients with any posterior segment changes on fundoscopy.
4. Other ocular pathologies which cause diminution of vision. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To analyse the visual acuity for Distant vision (DV)with LogMAR CHART from base line.
2.To analyse the visual acuity for Near vision (NV) with Snellen’s near vision chart from baseline.
3.To analyse the cortical lens changes with Lens Opacity Classification System (LOCSIII) from base score.
4.To analyse the changes in Autorefraction.
5.To analyse the changes in the contrast sensitivity test from the baseline.
6.To analyse the effect of Vyoshadi Varti Anjana and Hareethakyadhi Anjana in relieving clinical features of Kaphaja Timira
|
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To analyse the improvement in CAT quest 9F questionnaire. |
45 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
17/07/2024 |
| 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="3"
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
|
Cataract is one among the avoidable blindness and major contributor to visual impairment. Immature Cortical cataract is ana incomplete clouding of cortex of natural intraocular lens causing visual disturbance. Currently as there is no established treatment in the management of cataract at early stages, surgery is the only line of treatment in the modern science. The ayurvedic management and the drug chosen could effectively manage the cataract and delays further progression of the disease. |