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CTRI Number  CTRI/2026/04/107585 [Registered on: 06/04/2026] Trial Registered Prospectively
Last Modified On: 06/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An Ayurvedic Management of Simple Myopia 
Scientific Title of Study   A Comparative clinical study to evaluate the efficacy of Shadangi varti Anjana and Usheeradi Anjana in the management of Prathama patalagata 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 DAKSHAYANI N 
Designation  PG SCHOLAR 
Affiliation  Government Ayurvedic Medical College 
Address  Department of PG Studies in Shalakya tantra, Government Ayurvedic Medical College, Dhanwantari road, Majestic, Bengaluru

Bangalore
KARNATAKA
560009
India 
Phone  7996620219  
Fax    
Email  veenachinnu9966@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SYED MUNAWAR PASHA 
Designation  HOD AND PROFESSOR 
Affiliation  Government Ayurvedic Medical College 
Address  Department of PG Studies in Shalakya tantra, Government Ayurvedic Medical College, Dhanwantari road, Majestic, Bengaluru

Bangalore
KARNATAKA
560009
India 
Phone  9886593932  
Fax    
Email  smpasha78@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SYED MUNAWAR PASHA 
Designation  HOD AND PROFESSOR 
Affiliation  Government Ayurvedic Medical College 
Address  Department of PG Studies in Shalakya tantra, Government Ayurvedic Medical College, Dhanwantari road, Majestic, Bengaluru

Bangalore
KARNATAKA
560009
India 
Phone  9886593932  
Fax    
Email  smpasha78@gmail.com  
 
Source of Monetary or Material Support  
Dr Dakshayani N, Government Ayurveda Medical College, Dhanvantari road, Majestic, Bengaluru-560009, Karnataka, India 
 
Primary Sponsor  
Name  Dr DAKSHAYANI N, Government Ayurvedic Medical College, Bengaluru 
Address  #549, Opposite Govt School,Near Sri Balamuri Vinayaka temple, Pattandur Agrahara, Whitefield post, Bengaluru-560066, Karnataka 
Type of Sponsor  Other [SELF] 
 
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 DAKSHAYANI N  Government Ayurveda Medical College, Bengaluru  Department of PG Studies in Shalakya tantra, Government Ayurvedic Medical College, Dhanwantari road, Majestic, Bengaluru-560009
Bangalore
KARNATAKA 
7996620219

veenachinnu9966@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,Government Ayurveda Medical College, Bengaluru  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: PRATHAMA-PATALAGATADOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: USHEERADI ANJANA, Reference: Ashtanga Hrudaya Uttaratantra, 13th chapter, verses 77–78, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 50(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: SHADANGI VARTI ANJANA, Reference: GADA NIGRAHA, 3rd chapter, 288th verse, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 50(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Anjana is done with varti after gharshana with madhu
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Subjects irrespective of gender, caste, religion.
Subjects between age group of 8 years to 35 years.
Clinical features as per classics.
Subjects having refractive error ranging from -0.25 to -3.00 diopters. 
 
ExclusionCriteria 
Details  Pathological myopia, Astigmatism, High myopia with degenerative and gross retinal changes.
Those contraindicated for Anjana karma.
Myopia associated with structural deformities like corneal opacity, keratoconus and keratoglobus.
Subjects who have underwent any of the refractive surgeries.Patients suffering from any of the systemic disorders like uncontrolled DM, Hypertension, TB etc.
Pregnant and lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Visual Acuity- Manually done using Snellen’s chart
2. Autorefractometry 
60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Blurred vision  60 days 
 
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)   22/04/2026 
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  

Prathama Patalagata Timira is one among the Drishtigata netra rogas. This condition is characterized by impairment in vision (Avyakta Darshana), particularly for distant objects. According to Ayurvedic principles, Prathama Patalagata Timira occurs due to the aggravation of Vatadi doshas, which ascend (Urdhwagamana) to the Siras and get localized in the Prathama Patala (first layer of the eye). A condition described in Ayurvedic texts is equivalent to simple myopia (nearsightedness)

Epidemiology and Conventional Treatment

Myopia has become a significant global public health concern, with increasing prevalence rates worldwide. In India, the prevalence of myopia in urban children aged 5-15 years has risen from 4.44% in 1999 to 21.15% in 2019. Due to the generational effect, there will be an overall increase in myopia prevalence across all age groups of 10.53% in the next three decades (2020 to 2050). According to sight saving review (1979) myopia is the 4th major cause of visual loss after cataract, glaucoma and senile macular degeneration.

Conventional treatments such as glasses, contact lenses, and surgery provides only symptomatic relief without addressing the underlying cause or preventing progression. Spectacles and contact lenses require lifelong dependence and may cause complications like:
Dry eye, allergic conjunctivitis, corneal abrasions, infections and corneal hypoxia.

Refractive surgeries like LASIK and PRK, though effective, are associated with adverse effects like: Dry eye, glare, halos, night-vision disturbances, regression of refractive error, corneal ectasia, and rare permanent visual impairment, and are expensive without guaranteeing a permanent cure.

Ayurveda acharyas explain many Kriyakalpas which are useful in ocular conditions. One among the kriyakalpas is Anjana, a traditional Ayurvedic procedure, involves applying medicinal pastes or powders to the inner side of the lower eyelids. This treatment has been mentioned in various Ayurvedic texts, including the Bruhat Trayees and Sharangadhara Samhita.

Usheeradi anjana explained in Ashtanga hrudaya is indicated in all types of Timira and Shadangi varti anjana, which has been mentioned in Gada nigraha is specifically indicated in Timira. These formulations may offer a safe, effective, and cost-efficient alternative to conventional treatments.


Considering all these facts, this work “A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHADANGI VARTI ANJANA AND USHEERADI ANJANA IN THE MANAGEMENT OF PRATHAMA PATALAGATA TIMIRA WITH SPECIAL REFERENCE TO SIMPLE MYOPIA" has been taken up.

HYPOTHESIS 

NULL HYPOTHESIS

HO- Shadangi varti anjana and Usheeradi anjana have no similar effect in the management of Prathama patalagata timira

ALTERNATE HYPOTHESIS

H1- Shadangi varti anjana is more effective in Prathama Patalagata Timira than Usheeradi anjana

H2- Usheeradi anjana is more effective in Prathama Patalagata Timira than Shadangi varti anjana. 


 
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