| CTRI Number |
CTRI/2025/10/096410 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| 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 effect of Nayanasukha Varti Anjana and Antioxidant Therapy in Kaphaj Kacha- Senile Immature Cortical Cataract. |
|
Scientific Title of Study
|
An Assessment of Effectiveness of Nayanasukha Varti Anjana with Antioxidant Therapy in Kaphaja Kacha (Senile Immature Cortical Cataract)- A Randomized Controlled Clinical Trial. |
| 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 Neha Anant Bhatavadekar |
| Designation |
PG Scholar |
| Affiliation |
Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. |
| Address |
OPD No.25, Shalakyatantra Department,Ground Floor, Dr.G.D.Pol Foundation, YMT Ayurvedic Medical College, Institutional Area, Sector 4 Kharghar.
Navi Mumbai, Raigarh MAHARASHTRA.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7057398800 |
| Fax |
|
| Email |
cpnneha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Vijay Magar |
| Designation |
Professor |
| Affiliation |
Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. |
| Address |
OPD No.25, Shalakyatantra Department,Ground Floor, Dr.G.D.Pol Foundation, YMT Ayurvedic Medical College, Institutional Area, Sector 4 Kharghar.
Navi Mumbai, Raigarh MAHARASHTRA.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9987335024 |
| Fax |
|
| Email |
sunitamagar66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Vijay Magar |
| Designation |
Professor |
| Affiliation |
Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. |
| Address |
OPD No.25, Shalakyatantra Department,Ground Floor, Dr.G.D.Pol Foundation, YMT Ayurvedic Medical College, Institutional Area, Sector 4 Kharghar.
Navi Mumbai, Raigarh MAHARASHTRA.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9987335024 |
| Fax |
|
| Email |
sunitamagar66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College and Hospital PG Institute. Institutional Area Sector 4 Kharghar Navi Mumbai. |
|
|
Primary Sponsor
|
| Name |
Dr. Neha Anant Bhatavadekar |
| Address |
OPD No.25, Shalakyatantra Department,Ground Floor, Dr.G.D.Pol Foundation, YMT Ayurvedic Medical College, Institutional Area, Sector 4 Kharghar.
Navi Mumbai, Raigarh MAHARASHTRA. |
| 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 Neha Anant Bhatavadekar |
Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College and Hospital |
OPD No. 25.Shalakyatantra Department, Ground Floor, Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College and Hospital PG Institute. Institutional Area Sector 4 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA.
Raigarh
MAHARASHTRA |
7057398800
cpnneha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Dr G D Pol Foundation YMT Ayurvedic medical college and charitable hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H258||Other age-related cataract. Ayurveda Condition: KACAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Antioxidant therapy | Antioxidant is combination of Vit C, lutein, zinc, Vit E, zeaxanthin, copper, will be given once in a day for 60 days. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nayanasukha Varti Anjana, Reference: Chakradatta Netrarogadhikar, Route: Topical, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 60(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: Nayanasukha Varti Anjana will be given along with Antioxidant therapy.
Anjana will be applied in supine or sitting position. Eyelids will be retracted with left hand. With the help of right hand ring finger; Anjana will be applied from inner canthus to outer canthus in single stroke.After application of Anjana, patient will be asked to close the eyes and rotate the eyeballs. Whenever lacrimation stops and Samyak Lakshana seems, Prakshalana will be done with respective Aushadhisiddha Jala. |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms of Senile Immature Cortical Cataract (Kaphaja Kacha) such as Cloudy vision (Tanuchailavrottopamam),Lustreless Vision (Nishprabh Induarkapradip), Gradual loss of vision (Drushti Hiyate Kramat), Glare. Uniocular Polyopia/Diplopia.
Visual acuity between 6/9-6/36 by Snellen’s chart |
|
| ExclusionCriteria |
| Details |
Patients with Mature cataract and Hyper mature cataract.
Visual acuity - less than 6/36 by Snellen’s chart.
Patients with congenital and developmental, traumatic, complicated or metabolic cataract.
Patients having any other Posterior Segment Disease such as ARMD, NPDR.
Patients who are a K/C/O Uncontrolled DM/HTN/TB/IHD.
Patients having any other Serious Systemic Disease, Glaucoma.
Patients having symptoms of Timir, Vataj Kacha, Pittaj Kacha, All types of Linganash. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Nayanasukha Varti Anjana on symptoms of Kaphaja Kacha (Senile Immature Cortical Cataract) such as Tanuchailavrottopamam (Cloudy Vision), Nishprabh Induarkapradip (Lustreless Vision), Glare, Polyopia/Diplopia. |
Follow Up on 0th 15th 30th 45th 60th & 90th day with assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the effect seen in Visual Acuity.
2.To evaluate changes in Cataract Gradation, Graded as per Lens Opacification Criteria System (LOCS) III and Simplified Cataract Grading System based on Quadrant Occupied (COR).
3.To study effects seen in Contrast Sensitivity Test. |
Follow Up on 15th 30th 45th 60th & 90th day with assessment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/01/2026 |
| 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
|
This Randomized Controlled Clinical Trial is designed to evaluate the effectiveness of Nayanasukha Varti Anjana along with Antioxidant Therapy in management of Kaphaja Kacha(Senile Immature Cortical Cataract). A total of 60 patients between age group of 45-65years of age will be randomly selected and will be divided in two groups: The Control Group will receive Antioxidant Therapy only. The Trail group will receive Nayanasukha Varti Anjana along with Antioxidant Therapy for total 60 days. Assessment will be done on 0th,15th,30th,45th and 60th day and it will be based on subjective parameters such as Cloudy Vision, Lusterless Vision, Glare, Diplopia and objective parameters such as Visual Acuity, Contrast Sensitivity Test, Slit Lamp Examination for Cataract Gradation such as LOCS III Criteria And Gradation based on Quadrant Occupied(COR)Criteria. Data will be statistically analyzed to determine the efficacy of Nayanasukha Varti Anjana in improving vision and reducing and delaying further growth of senile immature cortical cataract along with Antioxidant Therapy. |