| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: PRATHAMA-PATALAGATADOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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.
|