| CTRI Number |
CTRI/2024/08/072916 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of suparni varti anjan in pratham patalgat timir with special reference to simple myopia |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the efficacy of Suparni 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 Bhagyashri Vishnu Kumbhar |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College and Hospital Islampur |
| Address |
OPD No. 10 Shalakya Tantra Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur Tal Walawa District Sangli Maharashtra India 415109
Sangli
MAHARASHTRA
415409
India |
| Phone |
7977287130 |
| Fax |
|
| Email |
bhagyashrikumbhar1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravin Vitthal chavan |
| Designation |
HOD and Guide of the Shalakyatantra Department |
| Affiliation |
LRP Ayurvedic Medical College and Hospital Islampur |
| Address |
OPD No 10 Shalakya Tantra Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur Taluka Walawa District Sangli Maharashtra India 415109
Sangli
MAHARASHTRA
415409
India |
| Phone |
9623318318 |
| Fax |
|
| Email |
drpravin222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyashri Vishnu Kumbhar |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College and Hospital Islampur |
| Address |
OPD No 10 Shalakya Tantra Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur Tal Walawa District Sangli Maharashtra India 415109
Sangli
MAHARASHTRA
415409
India |
| Phone |
7977287130 |
| Fax |
|
| Email |
bhagyashrikumbhar1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital Post Graduate PG Institute and Research Center Urun Islampur Taluka Walawa District Sangli Maharashtra India 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Bhagyashri Vishnu Kumbhar |
| Address |
Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital Post Graduate PG Institute and Research Center Urun Islampur Taluka Walawa District Sangli Maharashtra India 415409 |
| 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 Bhagyashri Vishnu Kumbhar |
Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital Islampur |
OPD No 10 Shalakya Tantra Department Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur Tal Walawa District Sangli Maharashtra India 415409
Sangli
MAHARASHTRA |
7977287130
bhagyashrikumbhar1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, LRP Ayurvedic Mahavidyalay, Islampur, Sangli. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: PRATHAMA-PATALAGATADOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: Sushrut Samhita Uttartantra 18 64 65, Procedure details: Procedure for Suparni Varti Anjan Application
1 Positioning: The patient will lie down on the table in a supine position.
2 Eye Cleaning: Clean the eyes with a sterile cotton swab.
3 Preparation: Rub Suparni Varti on shila (stone) with sterile water.
4 Application: Retract the lower eyelid with the left hand, & ask the patient to look upward. Apply Anjana over the lower eyelid margins from kannikaprant (inner canthus) to apang (outer canthus) or vice versa using anjan shalaka (applicator).
5 Eye Rotation: Instruct the patient to rotate their eyes to spread the Anjana evenly.
6 Post-Application Care: Advise the patient not to rub their eyes after Anjana Karma.
7 Cleaning: Clean the eyes with sterile water once the watery discharge stops.
8 Post-Procedure Advice:
1 Avoid exposure to wind, sun, or dust.
2 Avoid looking at minute or bright objects.
3 Follow hygienic measures.
Duration
Procedure Duration: Approximately 5-10 minutes.
Timing: To be performed in the evening.)
(1) Medicine Name: Suparni Varti , Reference: Gadnigrah shlok no 206, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 40(mg), Frequency: od, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: Sushrut Samhita Uttartantra 18 64 65, Procedure details: Procedure for Nayansukhadi Varti Anjan Application
1 Positioning: The patient will lie down on the table in a supine position.
2 Eye Cleaning: Clean the eyes with a sterile cotton swab.
3 Preparation: Rub Nayansukhadi Varti on shila (stone) with sterile water.
4 Application: Retract the lower eyelid with the left hand, & ask the patient to look upward. Apply Anjana over the lower eyelid margins from kannikaprant (inner canthus) to apang (outer canthus) or vice versa using anjan shalaka (applicator).
5 Eye Rotation: Instruct the patient to rotate their eyes to spread the Anjana evenly.
6 Post-Application Care: Advise the patient not to rub their eyes after Anjana Karma.
7 Cleaning: Clean the eyes with sterile water once the watery discharge stops.
8 Post-Procedure Advice:
1 Avoid exposure to wind, sun, or dust.
2 Avoid looking at minute or bright objects.
3 Follow hygienic measures.
Duration
Procedure Duration: Approximately 5-10 minutes.
Timing: To be performed in the evening.)
(1) Medicine Name: Nayansukhadi Varti, Reference: Bhaishajya ratnavali shlok no 202, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 40(mg), Frequency: od, Duration: 30 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 Timir will be selected.
3. Irrespective of sex, religion, education, and occupation,
4. The patient has a refractive error from -1.00 to -6.00 diopter. |
|
| ExclusionCriteria |
| Details |
1. age group-below 10 years and above 21 years. Patients with pathological myopia and
high myopia.
2. Patients with severe ocular conditions like retinoblastoma, leprosy, and malignant eye
disease, corneal ulcers, ocular tumour, or retinoblastoma, as well as those with
degenerative and retinal changes and Patients who are taking additional ocular medications
3. A recent eye operation was performed.
4. Patients with a refractive error below -1.00 and above -6.00 diopter. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Visual Acuity |
30 days study with Follow up on 0th 7th 15th 30th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Myopic Refraction |
30 days study with Follow up on 0th 7th 15th 30th days |
|
|
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)
|
02/09/2024 |
| 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="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
|
In India, the prevalence rate of myopia in children varies between 4% and 11.5%.Refractive surgeries are not cheap, and surgical complications can result in keratitis. In Ayurvedic texts, Timir is known as’ Aushadh Sadya Vyadhi’, i.e., a medically treated disease.Many medical remedies are prescribed for Timira, as well as various herbal preparations for improving visual acuity.This is Randomized Controlled Clinical trial in which Ayurvedic formulations will be provided to 80 patients showing signs and symptoms of Pratham Patalgat Timir, which is Myopia.There will be 2 groups: trail group and control group.The trail group will receive Suparni Varti Anjana, and the control group will receive Nayansakhadi Varti Anjana.The age group taken for the study trail will be between 10 to 21 years.Ayurvedic formulations will be given on 0th 6th 11th 16th 21th 26th 30th days.Follow up on 0th 7th 15th 30th days.Total duration of the study will be 1 year and 6 months. A final conclusion will be drawn on the basis of statistical methods. |