| CTRI Number |
CTRI/2026/01/101345 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the comparative effect of padaabhyanga with mahatriphaladi ghrita and trataka yoga kriya in treatment of simple myopia |
|
Scientific Title of Study
|
An Open Labelled Randomised Controlled Clinical Study To Evaluate The Chakshushya Property Of Padaabhyanga With Mahatriphaladi Ghrita In Timira 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 Gitanjali Patidar |
| Designation |
PG Scholar |
| Affiliation |
Parul University |
| Address |
Room no. 406 Department of Shalakya Tantra Parul Institute of Ayurved Parul University P O Limda Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
8889393914 |
| Fax |
|
| Email |
gitanjalipatidar1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjiri Keskar |
| Designation |
HOD Professor |
| Affiliation |
Parul University |
| Address |
Room no. 406 Department of Shalakya Tantra Parul Institute of Ayurved Parul University P O Limda Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9822606358 |
| Fax |
|
| Email |
manjirikeskar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjiri Keskar |
| Designation |
HOD Profesor |
| Affiliation |
Parul University |
| Address |
Room no. 406 Department of Shalakya Tantra Parul Institute of Ayurved Parul University P O Limda Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9822606358 |
| Fax |
|
| Email |
manjirikeskar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of ayurved, parul university limda, Vadodara,gujarat,391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul Institute Of Ayurved,Parul University, P.O Limda, Waghodia,391760 |
| 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 Manjiri Keskar |
Parul Ayurved Hospital |
Department of Shalakya Tantra OPD No. 112 Parul Ayurveda Hospital
Vadodara
GUJARAT |
09822606358
manjirikeskar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग on sole and planter region. | (Procedure Reference: Sushruta Samhita Chikitsa Sthan 24/70, Procedure details: Padaabhyanga with Mahatriphaladi Ghrita ~10 min per day for 48 days.)
(1) Medicine Name: Mahatriphaladi Ghrita, Reference: Astang hridayam Uttartantra 13/12-13, Route: Topical, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 48 Days | | 2 | Comparator Arm | Procedure | - | | (Procedure Reference: HATHYOGA PRADIPIKA 2/31, Procedure details: TRATAKA YOGA KRIYA :- Place a candle 2 feet infront of patient with the flame at the level of eye. Continue until the onset of lacrimation, daily for a period of 48 days. )
|
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with lens power between -0.25 to -5D.
2.Patient of either sex presenting with signs and symptoms of simple myopia along with asthenopic symptoms.
3.Patient who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.K/c/o of systemic disease
2.Patient with conditions such as cataract, POAG,Pterygium,PDR,Phthisis bulbi,corneal ulcer,Keratoconus,Keratoglobus,other major ophthalmic complaints,patient who have undergone any refractive surgeries will not be enrolled in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in visual acuity
2.Reduction in subjective symptoms
|
48 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of an evidence-based intrgrative ayurvedic procedure for myopia management. |
48 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="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
|
Timira is netra vikara classified under drustigata roga which cause vision disturbance.Ayurveda describes four stages of Timira, based on the depth of dosha vitiation in the ocular structures, known as Patalas.Doshas localized in the first Patala cause blurred vision, difficulty in seeing objects distinctly. This stage closely resembles refractive errors.
References and benefits of Padabhyanga the classical texts (Brihattrayee—Charaka Samhita, Sushruta Samhita, and Ashtanga Hridaya) mention Padabhyanga as a daily practice for overall well-being.
In Ayurveda, the feet hold great significance because they contain 11 vital Marma points out of the 107 Marmas in the body.These marma points are energy centers that influence various physiological and neurological functions. Since the feet serve as the foundation of the body and contain nerve endings connected to different organs, their care is essential for overall health.
Although Ayurvedic texts strongly advocate Padabhyanga, its scientific validation through clinical trials is limited. A systematic study can help establish evidence- based benefits of foot massage in preventing or managing refractive errors (Timira),, and eye strain. Can be a cost-effective, non-invasive, and holistic adjunct to conventional treatments. To establish the scientific validation,EEG will be done for patients. |