| CTRI Number |
CTRI/2025/08/093157 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Jeevanthyadi Ghritapan in Timir with special reference to Myopia in school going children. |
|
Scientific Title of Study
|
Single Arm Clinical Study To Evaluate the efficiency of Jeevanthyadi Ghrutpan in Timir with special reference to Myopia in school going children. |
| 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 Ojas Ajay Dhobe |
| Designation |
MD Scholar Shalakyatantra (Ayurveda) |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Center |
| Address |
Department of Shalakyatantra OPD No 11, Unit 1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Center, Uran Islampur Tal Walawa,Sangli Maharashtra
Sangli MAHARASHTRA 415409 India |
| Phone |
7020958205 |
| Fax |
|
| Email |
princydhobe99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neeta Ramesh Patil |
| Designation |
Assistant Professor |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Center |
| Address |
Department of Shalakyatantra OPD No 11,Unit 1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Center,Uran Islampur Tal Walawa,Sangli Maharashtra
Sangli MAHARASHTRA 415409 India |
| Phone |
9975335457 |
| Fax |
|
| Email |
drneetapatil@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Neeta Ramesh Patil |
| Designation |
Assistant Professor |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Center |
| Address |
Department of Shalakyatantra OPD No 11, Unit 1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Center,Uran Islampur Tal Walawa,Sangli Maharashtra
Sangli MAHARASHTRA 415409 India |
| Phone |
9975335457 |
| Fax |
|
| Email |
drneetapatil@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Center,Uran Islampur,Tal Walawa,Sangli- 415409, Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Dr Ojas Ajay Dhobe |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Center,Uran Islampur,Tal Walawa,Sangli- 415409, Maharashtra,India |
| 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 Ojas Ajay Dhobe |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Center |
Department of Shalakyatantra,OPD No 11,Unit 1,LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Center, Uran Islampur,Tal Walawa,Sangli- 415409, Maharashtra,India Sangli MAHARASHTRA |
7020958205
princydhobe99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LRP Ayurvedic Medical College Institutional Ethical Committee |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jeevantyadi Ghrut, Reference: Ashtanga Hrudayam Uttarasthana Adhyay 13/2-3, Route: Oral, Dosage Form: Ghrita, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing for trial.
2. Patient having simple Myopia with low error less or equal minus 3D with normal ophthalmoscopic findings. (Optic Disc - margins sharp, yellowish orange to pink colour, shape round or oval, Vessels - No arterial light reflex, No exudates or haemorrhages, Macula-Macula is located 2.5 disc diameter temporal to optic disc.)
3. Patient of Age group between 5-17 years with sign and symptoms of simple myopia as per Ayurveda and Modern aspect. (Avyaktani Rupani Sarvaneva Prapashyati i. e. Blurred vision, Asthenopia) |
|
| ExclusionCriteria |
| Details |
A. Patients of Moderate Myopia (when the error is between -3D to -6D)
B. Patients of High Myopia (when the error is more or equal to -6 D)
C. Patients having any other known ocular pathology involving Chalazion, Stye, Glaucoma, Cataract, Retinopathy, Corneal ulcer, Conjunctivitis, Uveitis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Jeevantyadi ghritapan in timir with special reference to Myopia in school going children |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
11/09/2025 |
| 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="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
|
Shalakya Tantra addresses illnesses that arise above the clavicle. Timir can be found in our ancient books that states eyeball has six patals or layers, of which two are ’Bahya’ and are referred to as Bahya vartmagat patalas, while the remaining four cover the eyeball. These four netra patals are afflicted, which causes Timira to appear. Doshas that become asharya in the Pratham patal result in "aspashta roopa darshan," which is the pradurbhava of "Timira." When Timira is connected to "Roga," it is referred to as "Kacha".
Sushruta states that Timir is caused by a variety of factors that,when it enters the internal orbital organs through Sira and resides in First Patala, cause pathology in that area. This Timirarambhak dosha produces a slight veiling of the eyes. Vaghbhat claims that clear objects might also appear blurry for no apparent reason. Sushruta states that when this Timirarambhak dosha reaches Diwityapatala, vision continues to deteriorate. Flies, mosquitoes, hair,cobwebs, ornaments (Mandala, Pataka), oasis (Mrugjala), earrings(Kundala), star movement, or frog hopping (Pariplava) are examples of hallucination-like items.thread cannot flow through a needle; somebody with defective perception (Index Hypermetropia or Myopia) perceives far-off objects as if they are closer and nearer.
Vagbhat states that when dosha enters Diwityapatala, Bhuta, orexisting close items, are seen easily, whereas Abhuta, or nonexistentfigures like flies, mosquitoes, hair, etc., are not visible.
Clinical picture of Timir can nearly stimulates with Myopia. Study goal is to indentify treatment for Timir that is Myopia in children .As Condition becoming widespread in the child group.
Jeevanthyadi ghrit described in Ashtang hridayam uttarstan adhyay 13 shlok 2-3 ,noted for its Rasayana(rejuvenating) and Chakshushya (eye-beneficial) qualities.
This is accurate given that the number of people who need to wear glasses is rising daily. According to data the prevalence of Myopia is estimated to be 2–10% of school going children in India so it has became crucial to investigate alternative treatment strategy for management of myopia due to lack of management and only modern alternative available is spectacles. |