| CTRI Number |
CTRI/2025/02/080099 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| 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
|
study the Effect of Laghumalini Vasant in Pratham Patalgat Timir |
|
Scientific Title of Study
|
Open randomized Control Clinical Trial of Laghumalini Vasant 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 Usha Ghorpade |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Ayurved Medial College Post Graduation And Research Center Ashta |
| Address |
5th floor , Shalakyatantra department, Hon Shri Annasaheb Dange Ayurved
medical College Post Graduate And Research Center Ashta Tal walawa Dist Sangli
Maharashtra Shalakyatantra Department 5th floor
Sangli
MAHARASHTRA
416301
India |
| Phone |
8275483982 |
| Fax |
|
| Email |
kumaji86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Kate |
| Designation |
Head of Department |
| Affiliation |
Hon Shri Annasaheb Ayurved Medial College Post Graduation And Research Center Ashta |
| Address |
5th floor Shalakyatantra department, Hon Shri Annasaheb Dange Ayurved
medical College Post Graduate And Research Center Ashta Tal walawa Dist Sangli
Maharashtra Shalakyatantra Department 5th floor
Sangli
MAHARASHTRA
416301
India |
| Phone |
9404701645 |
| Fax |
|
| Email |
drsujatakate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Kate |
| Designation |
Head of Department |
| Affiliation |
Hon Shri Annasaheb Ayurved Medial College Post Graduation And Research Center Ashta |
| Address |
5th floor Shalakyatantra department, Hon Shri Annasaheb Dange Ayurved
medical College Post Graduation And Research Center Ashta Tal walawa Dist Sangli
Maharashtra Shalakyatantra Department 5th floor
Sangli
MAHARASHTRA
416301
India |
| Phone |
9404701645 |
| Fax |
|
| Email |
drsujatakate@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved College And Post Graduate Research Centre Ashta Tal Walwa Dist Sangli 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Usha Ghorpade |
| Address |
Shalakyatantra Opd Dhanvantari Ayurved Hospital Ashta Tal walwa Dist Sangli 416301 |
| Type of Sponsor |
Private medical college |
|
|
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 Usha Ghorpade |
Dhanvantari Hospital Ashta Sangli |
OPD no 2 , Netra OPD, Hon Shri Annasaheb Ayurved Medical College Post Graduate and Resarch Centre Ashta Tal Walawa Dist Sangli 416301
Sangli
MAHARASHTRA |
8275483982
kumaji86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Hon Shri Annasaheb Ayurved Medical College Post Graduate and Resarch Centre Ashta Tal Walawa Dist Sangli 416301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H53||Visual disturbances. Ayurveda Condition: PRATHAMA-PATALAGATADOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Laghumalini Vasant, Reference: Yogratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -sahapana), Additional Information: -dose according to body weight | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Saptamrit Lauh, Reference: Bhaishjyaratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: sahanpana), Additional Information: Dose according to body weight |
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having signs and symptoms of Pratham Patalgat Timir will be included
2.Patients will be included from age group from 7-25yrs
3.Patients irrespective of gender, socioeconomic status, religion, occupation, educational status, cast and marital status will be included
4.The patients having simple myopia
5. The patients having blurring of vision |
|
| ExclusionCriteria |
| Details |
1. Patient having traumatic & inflammatory injuries to eye.
2. Patients having malignancy, hypertension, diabetes, viral infections & other major retinal diseases maculopathy
3. Patients having sign & symptoms of Dwitiya, Tritiy and Chaturth Patalgat Timir.
4. Patients having post operative Myopia.
5. Patients suffering from infectious diseases like tubercular infection
6.Patients having congenital myopia and pathological myopia |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Laghumalini Vasant is effective in Pratham Patalgat Timir |
Once at night for 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Both Lagumalini Vasant & Saptamrit Loha are eqaually effective in Pratham Patalgat Timir |
Once in night for 30 days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
17/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Most of signs and symptoms of Prathampatalgat Timir similar with Simple Myopia in which error of refraction is seen.It affects 20-40% of young generation.Laghumalini Vasant mentioned in Yogratnakar is said as sarvroghar in shishus.Kharpar used in Laghumalini Vasant is netraroghar and chakshushya.Instead of doing Kriyakalpas oral consumption will be easy method for children. |