| CTRI Number |
CTRI/2024/09/073945 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and Efficacy of ANJANA in immature uncomplicated cataract |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of ANJANA in patients suffering from immature uncomplicated cataract-An open label, single-center, single-arm, prospective, interventional clinical study. |
| Trial Acronym |
AN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN/24/01, Version 1.0, Dated 04/04/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Pradip Kumar Panda |
| Designation |
Dean |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
1st Floor
Department of Shalakya Tantra
Sri Sri College of Ayurvedic Science and Research Hospital
Sri Sri University
Sri Sri Vihar
Bidyadharpur
Ward No 3
Cuttack
754006
Odisha
Cuttack
ORISSA
754006
India |
| Phone |
08280252401 |
| Fax |
|
| Email |
pandapk9092@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Pradip Kumar Panda |
| Designation |
Dean Sri Sri College of Ayurvedic Science and Research Hospital |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Sri Sri College of Ayurvedic Science and Research Hospital
Sri Sri University
Sri Sri Vihar
Bidyadharpur
Ward No 3
Cuttack
754006
Odisha
ORISSA
754006
India |
| Phone |
08280252401 |
| Fax |
|
| Email |
pandapk9092@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Pradip Kumar Panda |
| Designation |
Dean Sri Sri College of Ayurvedic Science and Research Hospital |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Sri Sri College of Ayurvedic Science and Research Hospital
Sri Sri University
Sri Sri Vihar
Bidyadharpur
Ward No 3
Cuttack
754006
Odisha
ORISSA
754006
India |
| Phone |
08280252401 |
| Fax |
|
| Email |
pandapk9092@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital
Sri Sri University
Sri Sri Vihar
Bidyadharpur
Ward No 3
Cuttack
754006 |
|
|
Primary Sponsor
|
| Name |
Netraum Ayurveda Pvt. Ltd. |
| Address |
95
Jairam complex
Raipur
Chhattisgarh
492001 |
| Type of Sponsor |
Other [Ayurvedic] |
|
|
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 |
| Prof Dr Pradip Kumar Panda |
Sri Sri College of Ayurvedic Science and Research Hospital |
1st Floor
Department of Shalakya Tantra
Sri Sri University, Sri Sri Vihar
Bidyadharpur
Ward No 3
Cuttack
754006
Odisha
Cuttack
ORISSA |
08280252401
pandapk9092@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kar Vision Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: KAPAJA-NETRAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Anjana, Reference: Kajal, Route: Ocular, Dosage Form: Lepa Churna, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1.Patient willing to provide written informed consent
2.Premenopausal female of age 30 – 70 years
3.Subjects with immature (Asymptomatic or Symptomatic) and uncomplicated cataract not requiring surgery.
4.Subjects having cataract with possible grading on slit lamp bio microscopy according to Lenticular Opacity Classification System II.
5.Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study. |
|
| ExclusionCriteria |
| Details |
1.Subjects with congenital cataract, mature and hyper mature cataract.
2.Subjects having any other ophthalmic condition like glaucoma, diabetic retinopathy, macular degeneration, retinitis pigmentosa which requires urgent and separate treatment.
3.Subjects with Uncontrolled Diabetes and Uncontrolled Hypertension.
4.Subjects taking Steroid treatment and or any kind of immunosuppressive therapy.
5.Subjects participating in any other clinical study or having participated in any other Study 3 months prior to screening in the present study.
6.Subjects who are in general sensitive to any eye drops.
7.A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period.
8.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in lens evaluated on LOCS II in Slit lamp Test between subjects using ANJANA at visit 3 and visit 4 as compared to baseline visit.
Changes in direct and indirect ophthalmoscopic examinations between subjects using ANJANA at visit 3 and visit 4 as compared to baseline visit. |
Baseline to EOS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparative clinical assessment of symptoms related to cataract in visit 4 as compared to baseline visit.
Assessment of other changes in eyes-related symptoms like itching, tiredness, irritation, burning, etc. if any.
Global assessment for overall change by the subject & investigator at the end of 90 days of study treatment.
Adverse events reported during the study.
Serious adverse events were reported during the study.
Overall tolerability evaluation at the end of the study. |
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/09/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Evaluation of efficacy and safety of ANJANA in patients suffering from immature uncomplicated cataract - An open label, Single Center, single arm, prospective, interventional clinical study |