| CTRI Number |
CTRI/2025/11/097662 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation Of Triphala Vati with Sarpi and Madhu Over Axial Length in Developmental Myopia: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Efficacy of Ayurvedic yoga (Tripala with Sarpi & Madhu) in comparison to Standard of care on Axial length in Prathama Patalagata Timira (Simple Myopia) Among 8 -12-Year-Old School Children in Belagavi: A Randomized Controlled 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 |
Hemlata Shete |
| Designation |
Associate professor |
| Affiliation |
KAHERS Shri BMK Ayurveda Mahavidyalaya |
| Address |
A8 JNMC campus KLE Nehru nagar Belagavi
Department of Shalakya tantra, OPD No. 27, Shalakya tantra netra Division, KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka 590003
Belgaum
KARNATAKA
590010
India |
| Phone |
8217623771 |
| Fax |
|
| Email |
hemalata.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Hemlata Shete |
| Designation |
Associate professor |
| Affiliation |
KAHERS Shri BMK Ayurveda Mahavidyalaya |
| Address |
A8 JNMC campus KLE Nehru nagar Belagavi
Department of Shalakya tantra, OPD No. 27, Shalakya tantra netra Division, KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka 590003
Belgaum
KARNATAKA
590010
India |
| Phone |
8217623771 |
| Fax |
|
| Email |
hemalata.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Hemlata Shete |
| Designation |
Associate professor |
| Affiliation |
KAHERS Shri BMK Ayurveda Mahavidyalaya |
| Address |
A8 JNMC campus KLE Nehru nagar Belagavi
Department of Shalakya tantra, OPD No. 27, Shalakya tantra netra Division, KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka 590003
Belgaum
KARNATAKA
590010
India |
| Phone |
8217623771 |
| Fax |
|
| Email |
hemalata.kaher@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
hemlata Shete |
| Address |
KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka 590003 |
| Type of Sponsor |
Other [] |
|
|
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 Hemlata shete |
KLE Ayurved hospital |
Department of Shalakya tantra, OPD No. 27, Shalakya tantra netra Division, KLE Ayurveda hospital Belagavi Karnataka 590003
Belgaum
KARNATAKA |
8217623771
hemalata.kaher@kleayurworld.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital Shahapur Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H538||Other 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: Triphala, Reference: Ashtang hridaya sutrasthana 8th chapter 44th shloka, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1800(mg), Frequency: hs, Bhaishajya Kal: Pragbhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: sarpi and madhu), Additional Information: triphala sarpi and Madhu will be taken in 1:2:3 ratio | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard | Eyeglasses: Single-vision spectacles |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
8-12 years of age of either gender
The legal guardian of the subject voluntarily signed the written informed consent, and the subject should approve verbal consent voluntarily.
Refractive errors ranging between –0.25D to –3.00D of spherical correction
May or may not associate with asthenopic features like headache, watering, redness etc
|
|
| ExclusionCriteria |
| Details |
less than 8years and more than 12 years
Allergic to this product or its excipients
Suffering from eye diseases that may affect vision eg allergic manifestations cataract glaucoma macular disease keratopathy uveitis retinal detachment Retinitis pigmentosa amblyopia strabismus vitreal hemorrhages inflammatory disorders etc
Use of other myopia control methods, medications and others including traditional Chinese medicine, auricular acupuncture massage accommodative flippers red light therapy instrument etc within 3 months before screening |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A-scan Biometry is used for measuring Axial length |
Axial length will be measured at baseline, 90 days and 180 days, and 365 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Classical signs & symptoms and Blurred vision for distant objects (Avyakta Darshana)
Headache (Shirobhitapa),
Watering (Netrasrava),
Eye strain (Netrayasa)
Burning sensation (Netradaha)
The best corrected vision will be assessed by refraction
Visual Activity (Naked eye/Pin hole/Present glasses/Near vision) |
Baseline, 90 days and 180 days, and 365 days. |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2025 |
| 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="0"
Months="6"
Days="5" |
|
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
|
research study titled Efficacy of Ayurvedic yoga (Tripala with Sarpi,
and Madhu ) in comparison to Standard of care on Axial length in Prathama Patalagata Timira
(Simple Myopia) Among 8 -12-Year-Old School Children in Belagavi: A Randomized
Controlled Trial. Nowadays, many children are developing
difficulty in seeing distant objects clearly because of more screen time and
less outdoor play. This condition is called myopia (short-sightedness).
If it is not taken care of early, it can increase with age and affect the
child’s studies and daily life. Ayurveda describes safe and natural remedies to
keep the eyes healthy. Among them, the use of Triphala vati with honey and ghee has been mentioned
for eye care since ancient times. This study is being done to see how well this
Ayurvedic combination helps in improving eye health in children with myopia.This study will recruit 86 subjects over 3 months and the intervention will be given for a perod of 6 months in study group along with eye glasses. Outcome will be asses at baseline , 90 days, 180 days and 270 days and 365 days. |