| CTRI Number |
CTRI/2025/05/087330 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Remedy Gandhak Kalpa for Myopia Treatment
|
|
Scientific Title of Study
|
PHARMACEUTICO ANALYTICAL and EXPLORATORY THERAPEUTIC POTENTIAL OF GANDHAKA KALPA and AKSHITARAPANA WITH GOGHRITA IN 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 peeyusha pandey |
| Designation |
MD scholar |
| Affiliation |
PGIA , jodhpur |
| Address |
Dr S R Rajasthan Ayurveda University, Jodhpur
RAJASTHAN 342037 India
Dept of Rasa Shastra Post Graduate Institute of Ayurveda Dr S R
Rajasthan Ayurveda University Jodhpur
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8005567758 |
| Fax |
|
| Email |
shreenidhiir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr peeyusha pandey |
| Designation |
MD scholar |
| Affiliation |
PGIA , jodhpur |
| Address |
Dr S R
Rajasthan Ayurveda University Jodhpur
Jodhpur
RAJASTHAN
342037
India
Dept of Rasa Shastra Post Graduate Institute of Ayurveda Dr S R
Rajasthan Ayurveda University Jodhpur
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8005567758 |
| Fax |
|
| Email |
shreenidhiir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr peeyusha pandey |
| Designation |
MD scholar |
| Affiliation |
PGIA , jodhpur |
| Address |
Dr S R
Rajasthan Ayurveda University Jodhpur
Dept of Rasa Shastra Post Graduate Institute of Ayurveda Dr S R
Rajasthan Ayurveda University Jodhpur
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8005567758 |
| Fax |
|
| Email |
shreenidhiir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. S R Rajasthan Ayurved University, Karwar, Nagaur road, Jodhpur |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved, Jodhpur, Rajasthan |
| Address |
PGIA, Dr S R Rajasthan Ayurved University, Jodhpur, Rajasthan,
342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Peeyusha pandey |
kudi bhagtasini sector 2 jodhpur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr peeyusha pandey |
Sanjeevani Hospital |
Dr S R
Rajasthan Ayurveda University Jodhpur
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN |
08005567758
shreenidhiir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H278||Other specified disorders of lens. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: gandhak kalpa, Reference: ras tarangini, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Myopia upto -6D will be included in the study.
|
|
| ExclusionCriteria |
| Details |
a) Patient age below 10 and above 25 years of age.
b) Patients having Pathological myopia condition.
c) Patient with recent eye surgery or having any trauma.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in subjective parameters |
90days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life of patient |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/03/2026 |
| 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="0"
Months="3"
Days="0" |
|
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
|
Myopia, a widespread refractive error in todays world and is becoming increasingly prevalent due to increased screen time and use of smartphones and gadgets for longer durations. The incidence of myopia in children is on the rise and worsens as they get older. The frequency of myopia in India is on the incline, particularly in urban areas. Among urban schoolchildren aged 5-15 years, the prevalence escalated from 4.4% in 1999 to 21.1% in 2019. Forecasts indicate that by 2030, it might reach approximately 31.89%, and by 2050, nearly 48.14%2. Gandhak Kalpa contains medicinal plants along with Shuddha Gandhak. Triphala and Bhringraj have antioxidant and anti inflammatory properties and are potent medicines for improving eyesight. |