| CTRI Number |
CTRI/2025/09/094820 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy of patradya varti anjan in pratham patalgat timir with special reference to simple myopia |
|
Scientific Title of Study
|
Randomized controlled clinical trial To evaluate the efficacy of patradya varti anjan in pratham patalgat timir with special reference to simple myopia |
| 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 SUCHITA KESHAV SONWALE |
| Designation |
PG SCHOLAR |
| Affiliation |
LRP AYURVEDIC COLLEGE AND HOSPITAL PG INSTITUTE AND RESEARCH CENTRE,URAN ISLAMPUR |
| Address |
Departmentof shalakyatantra unit 1 lrp aurvedic medical college and hospital and post graduate institute and research centre islampur sangali,maharashtra.
Sangli
MAHARASHTRA
415409
India |
| Phone |
9284422122 |
| Fax |
|
| Email |
sonwalesuchita1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRAVIN CHAVAN |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
LRP AYURVEDIC COLLEGE AND HOSPITAL PG INSTITUTE AND RESEARCH CENTRE,URAN ISLAMPUR |
| Address |
Departmentof shalakyatantra unit 1 lrp aurvedic medical college and hospital and post graduate institute and research centre islampur sangali,maharashtra.
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822338613 |
| Fax |
|
| Email |
drpravin999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUCHITA KESHAV SONWALE |
| Designation |
PG SCHOLAR |
| Affiliation |
LRP AYURVEDIC COLLEGE AND HOSPITAL PG INSTITUTE AND RESEARCH CENTRE,URAN ISLAMPUR |
| Address |
Departmentof shalakyatantra unit 1 lrp aurvedic medical college and hospital and post graduate institute and research centre islampur sangali,maharashtra.
Sangli
MAHARASHTRA
415409
India |
| Phone |
9284422122 |
| Fax |
|
| Email |
sonwalesuchita1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Dist Sangli 415409 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
DR SUCHITA KESHAV SONWALE |
| Address |
Department of shalakyatantra unit 1 lrp ayurvedic medical college and hospital PG institute and research centre urun islampur sangali,maharastra.415409,india |
| 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 SUCHITA KESHAV SONWALE |
Lrp ayurvedic college and hospital pg institute and research centre,uran islampur sangli,maharastra. |
Department of shalakyatantra unit 1 Lrp ayurvedic college and hospital pg institute and research centre,uran islampur sangli,maharastra.415409 India
Sangli
MAHARASHTRA |
9284422122
sonwalesuchita1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H00-H59||Diseases of the eye and adnexa. Ayurveda Condition: TIMIRAH, (2) ICD-10 Condition:H538||Other visual disturbances. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vartiH, वर्तिः | (Procedure Reference: सु.उ.१८,६४/६५, Procedure details: 1.Supine position can be given to the patient and their eyes will be cleaned
using a sterile cotton swab.
2. Application of anjana done over the lower eyelid margins from
kaninikaprant to apang or from apang to kaninikaprant with the help of anjan
shalaka.
3. The patient has asked to rotate their eyes after applying anjana so it spreads
over their eyelids.)
(1) Medicine Name: Patradya varti, Reference: वृन्ध माधव ६१/६४, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 40(mg), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | vartiH, वर्तिः | (Procedure Reference: सु.उ.१८,६४/६५, Procedure details: 1.supine position can be given to the patient and their eyes will be cleaned
using a sterile cotton swab.
2. Application of anjana done over the lower eyelid margins from
kaninikaprant to apang or from apang to kaninikaprant with the help of anjan
shalaka.
3. The patient has asked to rotate their eyes after applying anjana so it spreads
over their eyelids.)
(1) Medicine Name: Haritkyadi varti, Reference: भैषज्य रत्नावली ६४/१९५/चक्रद्त ५९/१०, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 40(mg), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Group: 10 to 21 years
2. A patient having classical symptoms of timira will be selected,
Irrespective of sex, religion, education, and occupation.
3.Patients with low myopia (Less than or equal to -3D Sph)
4. Patients with spherical power lenses will be taken |
|
| ExclusionCriteria |
| Details |
1)Age group-below 10 years and above 21 years.
2)Patients with pathological myopia and high myopia,
severe ocular conditions like retinoblastoma, malignant eye disease,
corneal ulcers, ocular tumor.
3)Patients with degenerative and retinal changes and Patients who are taking
additional ocular medications
4)A recent eye operation was performed.
5)Patients of Moderate Myopia (when the error is between -3D to -6D).
6)Patients suffering from any of the systemic disorders and infections like
Hypertension, Diabetes, Tuberculosis, Syphilis, HIV, HBsAg etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficiency of Patradya Varti Anjana in the management of Pratham Patalagat timira with special reference to simple myopia |
Application of patradya varti anjan on 0th,6th,11th,16th,21th,26th, 30 th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study in detail literature about Pratham Patalagat timira according to ayurveda.
2. To study in detail literature about simple myopia according to Modern.
3.To study the prepration of patradya varti anjana and haritkyadi varti anjana.
4. To compare efficacy of patradya varti anjana with haritkyadi varti anjana. |
Application of patradya varti anjan on 0th,6th,11th,16th,21th,26th, 30 th day.Follow up on 08th, 16th,24th,32thday. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
28/09/2025 |
| 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
|
Pratham patalgat timir with special reference to simple myopia is the most common eye disease and important haelth issue in India. Ocular health can be maintained and promoted by existing treatment in ayurveda. Tarpana , Anjana, Nasya , Putpak, Shirobasti are the various therapeutic majors mentioned for treatment of timir. Anjana are such widely used procedures used in treatment of simple myopia. There are no side effects and probable complications of these procedures. Patradya varti anjana mentioned in vrundhmadhav samhita includes the coponents which are easily available and it has good ocular absorption. Hence, the study intended to copare the action of different anjana in the management of pratham patalgat timir with special reference to simple myopia. |