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CTRI Number  CTRI/2026/03/106414 [Registered on: 17/03/2026] Trial Registered Prospectively
Last Modified On: 17/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to see the effect of an Ayurvedic preparation, Vasamruta Guggulu Ghrita in Individuals with Myopia (Pratham -Dwitiya Patalagata Timira) 
Scientific Title of Study   A randomized controlled Trial to evaluate efficacy of oral administration of Vasamruta Guggulu Ghrita with spectacles in Pratham-Dwitiya Patalgata Timira with reference to 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 Rutuja Dharma Navale 
Designation  MS Scholar Shalakyatantra (Ayurveda) 
Affiliation  MAMS Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD NO.9 Department of Shalakyatantra ,Sane Guruji Arogya Kendra,Malwadi Road Hadapsar,Pune MAHARASHTRA 411028 INDIA Pune MAHARASHTRA 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  7776841877  
Fax    
Email  rutujanavale12898@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Sumedha Y Kotangale 
Designation  H.O.D. Shalakyatantra 
Affiliation  MAMS Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD NO.9 Department of Shalakyatantra ,Sane Guruji Arogya Kendra,Malwadi Road Hadapsar,Pune MAHARASHTRA 411028 INDIA Pune MAHARASHTRA 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  8275298480  
Fax    
Email  sumedhayk@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Sumedha Y Kotangale 
Designation  H.O.D. Shalakyatantra 
Affiliation  MAMS Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD NO.9 Department of Shalakyatantra ,Sane Guruji Arogya Kendra,Malwadi Road Hadapsar,Pune MAHARASHTRA 411028 INDIA Pune MAHARASHTRA 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  8275298480  
Fax    
Email  sumedhayk@yahoo.com  
 
Source of Monetary or Material Support  
Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra 411028 
 
Primary Sponsor  
Name  Sane Guruji Arogya Kendra 
Address  OPD NO.9 Department of Shalakyatantra ,Sane Guruji Arogya Kendra,Malwadi Road Hadapsar,Pune MAHARASHTRA 411028 INDIA 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rutuja Dharma Navale  MAMS Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar  OPD NO.9 Department of Shalakyatantra ,Sane Guruji Arogya Kendra,Malwadi Road Hadapsar,Pune MAHARASHTRA 411028 INDIA Pune MAHARASHTRA 411028 India
Pune
MAHARASHTRA 		 7776841877
-
rutujanavale12898@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
M.A.M.s SSAM and Sane Guruji Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vasamruta Guggulu Ghrita, Reference: Rasa-Ratnakar, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -Spectacles will be given with oral administration of Ghrita
2Comparator Arm (Non Ayurveda)-SpectaclesSpectacles will be given for continuous use.
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Patient Enrolled with symptoms of Prathama-Dwitiya Patalagata Timira i.e. Avakatmekshateroopam (visual hallucination), Vyaktamapyanimitta (transient nature of blurriness), Dooramnekshate (difficulty of distant vision) in Shalakya OPD.
2. Age-19 to 40 years.
3. Patient who have less than -3D refractive index in the eyes.
4. Patient of either gender.
5. Patient having visual acuity of 6/12, 6/18, 6/24, 6/36, 6/60, or less than 6/60 in the eyes.
6. Patient who is ready to give consent.
 
 
ExclusionCriteria 
Details  1) Patient who have symptoms of Tritiya and Chaturtha Patalagata Timira will be excluded.
2) Congenital type of myopia, pathological type of myopia, acquired or secondary type of myopia that occurs due to
some factors or diseases i.e. post traumatic, drug induced, post keratitis. etc. will be excluded.
3) Myopia associated with other ocular diseases like cataract, glaucoma, etc.
4) Patient who have myopia associated with other refractive errors such as astigmatism,
presbyopia.
5) Patient who have known case of hypertension, diabetes mellitus, Rheumatic arthritis or any other arthritic conditions, rheumatic heart disease, thyroid disorder, asthma, Koch’s, HIV will be excluded.
6) Patient who have active infectious diseases i.e. viral, fungal, bacterial conjunctivitis
, trachoma, blepharitis.
7) Patient below 16 years and above 40 years will be excluded.
8) Patient who have refractive index more than -3D will be excluded.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Symptoms like avyakatmekshateroopam (visual hallucination), Vyaktamapyanimitta (transient nature of blurriness), Dooramnekshate will be decreased  Follow up on 15th and 30th Day.Symptoms will be noted before and after treatment. Observational follow up will be on 45th Day  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   15/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/04/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
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  

In Vagbhata Samhita it is said that when vitiated doshas are in Prathama and Dwitiya Patal it is called as Timira and when vitiated doshas get into Tritaya Patal it is called as Kacha and when Chaturtha Patalgata Doshadushti happens it is said as Linganasha. The Lakshanas in Prathama and Dwitiya Patalgata Dosha Dusti are related to visual disturbances.Avakatmekshateroopam, Vyaktamapyanimitta, Dooramnekshate, by Vagbhata. Myopia is having similar signs and symptoms.
                According to Ayurveda Samhitas, Timira is Aushadha Sadhya Vyadhi, In Ayurveda Timira Chikitsa, Aabhyantar and Kriyakalpa Chikitsa yogas are given.As Aabhyantar chikitsa is more feasible and less studied in Timira Chikitsa Vasamruta Guggulu Ghrita is selected as Aabhyantar Chikitsa Yoga. The Kalpa consists of drugs like Triphala, Ghrita which are Chakshushya and Guggulu and Amruta and first two are having Rasayana properties. While Vasa, Nimba, Patolpatra are having Pachana Gunas.  In ‘Rasa Ratnakar’ it is mentioned that Vasamruta Guggulu Ghrita is useful in various types of eye conditions including Patal, Akshiraag, Shopha, Kandu, Mala, Timira and Kacha of Netra.
 
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