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CTRI Number  CTRI/2025/05/086180 [Registered on: 02/05/2025] Trial Registered Prospectively
Last Modified On: 22/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic Management Of Arma WSR to Pterygium 
Scientific Title of Study   A Comparative Clinical Study To Evaluate The Effect Of Marichanjana And Darvadyanjana In The Management Of Arma With Special Reference to Pterygium 
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 Divya Tukaram Moodi 
Designation  P G Scholar  
Affiliation  Government Ayurvedic Medical College 
Address  Department Of PG Studies In Shalakya Tantra,Government Ayurvedic Medical College, Dhanwantari road,Mejastic,Bengaluru.

Bangalore
KARNATAKA
560009
India 
Phone  9686469722  
Fax    
Email  divyatm21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Syed Munawar Pasha 
Designation  Professor 
Affiliation  Government Ayurvedic Medical College 
Address  Department Of PG Studies In Shalakya Tantra,Government Ayurvedic Medical College, Dhanwantari road,Mejastic,Bengaluru.

Bangalore
KARNATAKA
560009
India 
Phone  9886593932  
Fax    
Email  smpasha78@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Divya Tukaram Moodi 
Designation  P G Scholar 
Affiliation  Government Ayurvedic Medical College 
Address  Department Of PG Studies In Shalakya Tantra,Government Ayurvedic Medical College, Dhanwantari road,Mejastic,Bengaluru.

Bangalore
KARNATAKA
560009
India 
Phone  9686469722  
Fax    
Email  divyatm21@gmail.com  
 
Source of Monetary or Material Support  
Dr Divya Tukaram Moodi Government Ayurveda Medical College Bengaluru 
 
Primary Sponsor  
Name  Dr Divya Tukaram Moodi 
Address  Vivekananda Nagar,3rd Cross, BYADGI-581106 
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 Divya Tukaram Moodi  Government Ayurveda Medical College  Shalakya Tantra OPD, Room No.11, Government Ayurveda Medical College, Dhanwantari Road,Mejastic, Bengaluru
Bangalore
KARNATAKA 
9686469722

divyatm21@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:H111||Conjunctival degenerations and deposits. Ayurveda Condition: PRASTARI-ARMA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Marichanjana, Reference: Basavarajeeyam Netraroga adhyaya Chapter no 17, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 50(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Varthi in the form of Anjana
2Intervention ArmDrugClassical(1) Medicine Name: Darvadyanjana, Reference: Basavarajeeyam Netraroga adhyaya Chapter no 17, Route: Ocular, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 50(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Rasakriyanjana in the form of Anjana
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Patients between age group of 30 years to 70 years.
2 Clinical features as per classics.
3 Patients with Pterygium that is limited to limbus.
4 Controlled Diabetic patients
5 Controlled HTN Patients
 
 
ExclusionCriteria 
Details  1 Arma with any other ocular pathology.
2 Pseudo pterygium
3 Those contraindicated for Anjana karma.
4 Pregnant women and Lactating mother.

 
 
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 Pictorial presentation
2 Length
3 Thickness

 
60 Days  
 
Secondary Outcome  
Outcome  TimePoints 
1 Foriegn body sensation
2 Redness
3 Watering of eyes

 
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)   05/05/2025 
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="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  

 Arma is one among Shuklagataroga explained by Acharya Sushrutha and Acharya Vagbhata. It is defined as IYARTI GACCHATHI ITI ARMA. Which means gradually spreading of fleshy growth occurring in Shukla mandala. The Lakshanas of Arma can be correlated with signs and symptoms of Pterygium in modern ophthalmology. Pterygium is a wing shaped fold of conjunctiva encroaching upon cornea from either side within interpalpebral fissure. Pathologically Pterygium is an elastotic degeneration of subconjunctival tissue. In a population-based study from rural central India, prevalence of pterygium increased from 6.7±0.8% in the age group from 30–39 years to 25.3±2.1% in the age group of 70–79 years. The epidemiological studies around worldwide have shown that prevalence rates ranges from 0.3% to 37.46%.

Pterygium is more common in people living in hot climate, and in those who work outdoors. Thus it is considered as a response to prolonged effect of environmental factors such as exposure to sunlight (UV rays), dry heat, high wind and abundance of dust. Asymptomatic nature of the disease and non-availability of medical treatment are the main hurdles in management. Meanwhile it fails to decrease the complication such as development of cyst, ongoing diplopia, Dry eye, scleral or corneal melting. it not only affects the outlook of the patient, but also affects refractive astigmatism which can have significant impact on vision in advanced stage due to the invasion of cornea.

In modern science surgical treatment is only satisfactory approach. Recurrence after surgical excision is common and recurred lesions grow more aggressively than primary lesions. Cost of Surgery is too expensive. Hence to overcome the lacuna in modern therapeutics the present clinical study has been taken up. Therefore an alternative treatment which is safe, devoid of complication, easy to administer and cost effective is need for hour.

In Classics different treatment modalities are explained for the management of Arma mainly Lekhana, Chedhana, Anjana. Arma is a type of Mamsavriddhi (muscle like growth) hence Acharyas have indicated as Chedana sadya and Lekhana sadya vyadhiMarichanjanaand Darvadyanjana both are mentioned in Basavarajeeyam, Netraroghadhikara. Hence an attempt is made to compare the efficacy of Marichanjana and Darvadyanjana in management of ARMA

 NULL HYPOTHESIS

 H0 - Marichanjana is not effective in management of Arma with special reference to   pterygium.

 ALTERNATE HYPOTHESIS

H1 - Marichanjana Is more effective than Darvadyanjana i in management Arma with special reference to pterygium

H2 - Marichanjana is less effective than Darvadyanjana in management of Arma with special reference to pterygium.

 


 
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