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CTRI Number  CTRI/2025/04/085652 [Registered on: 25/04/2025] Trial Registered Prospectively
Last Modified On: 06/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   a study to see the effect of nayanasukhavarti anjana in prevention of recurrence of arma(pterigium) following arma chedana (pterigium excision) 
Scientific Title of Study   A controlled clinical study to evaluate the effect of Nayanasukhavarti Anjana in prevention of recurrence of Arma (Pterygium) following Arma Chedana. 
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 Nithin V  
Designation  PG Scholar 
Affiliation  Shri Jagadguru Gavisidheshwar Ayurvedic Medical College Koppal 
Address  Department of Shalakya tantra, Shri Jagadguru Gavisiddeshwara Ayurvedic Medical College, Gavi mata campus, Koppal Karnataka 583231
#53,Byrapura,Arakere post, Bengaluru north, Karnataka-562163
Koppal
KARNATAKA
583231
India 
Phone  9449920606  
Fax    
Email  nithinvsnv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Veerayya Hiremath 
Designation  Professor and HOD  
Affiliation  Shri Jagadguru Gavisidheshwar Ayurvedic Medical College Koppal 
Address  Department of Shalakya tantra, Shri Jagadguru Gavisiddeshwara Ayurvedic Medical College, Gavi mata campus, Koppal Karnataka 583231

Koppal
KARNATAKA
583231
India 
Phone  9448544376  
Fax    
Email  drvrh.aug15@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nithin V  
Designation  PG Scholar 
Affiliation  Shri Jagadguru Gavisidheshwar Ayurvedic Medical College Koppal 
Address  Department of Shalakya tantra, Shri Jagadguru Gavisiddeshwara Ayurvedic Medical College, Gavi mata campus, Koppal Karnataka 583231
#53,Byrapura,Arakere post, Bengaluru north, Karnataka-562163

KARNATAKA
583231
India 
Phone  9449920606  
Fax    
Email  nithinvsnv@gmail.com  
 
Source of Monetary or Material Support  
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College, Koppal, Karnataka, India -583231 
 
Primary Sponsor  
Name  Dr NITHIN V 
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College & Hospital, Koppal 583231 
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 NITHIN V  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital,Depatment of Shalakya Tantra, Gavi mata campus, Koppal, Karnataka 583231
Koppal
KARNATAKA 
7353843244

nithinvsnv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H110||Pterygium of eye. Ayurveda Condition: PRASTARI-ARMA, (2) ICD-10 Condition:H110||Pterygium of eye. Ayurveda Condition: SUKLARMA, (3) ICD-10 Condition:H110||Pterygium of eye. Ayurveda Condition: ADHIMAMSAJARMA, (4) ICD-10 Condition:H110||Pterygium of eye. Ayurveda Condition: LOHITARMA/KSHATARMA, (5) ICD-10 Condition:H110||Pterygium of eye. Ayurveda Condition: SNAYVARMA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Cedanakarma, छेदनकर्म (Procedure Reference: 8. Sushrutha, Sushrutha Samhitha of Susruta with the nibandhasangraha commentary of Sri Dalhanacharya edited by Vaidya Jadavji Trikamji Acharya and the rest. Chaukhambha Orientalia, Varanasi. Reprinted- 2019, Sutrasthana Chapter no 5, Shloka no 4, Procedure details: Patient will be asked to look to the opposite side of the arma. Arma will be lifted using Hook (Badisha Yantra). After lifting, arma will be held in forceps (Muchundi Yantra) and elevated. Then the elevated arma will be dissected from all sides with Castroviejo corneal scissors (Mandalagra Shastra). Arma will be removed after freeing from all the sides sparing the canthus side. 1/4th arma will be retained at its attachment. )
(1) Medicine Name: Nayanasukha varti Anjana, Reference: Dr. Kanjiv Lochan: Bhaisajya Ratnavali of Shri Govinda Dasji Bhisagratna Commented upon by Vaidya Shri Ambika Datta Shastri Chaukhambha Sanskrit Sansthan, Varnasi. Volume III,Ch.24 Netra roga, Edition Reprint 2014 p.293-294, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: bd, Duration: 30 Days
2Comparator Arm (Non Ayurveda)-Conjunctival autograftingSuperior rectus bridle suture will be applied using 3-0 silk. Pterygium will be excised using a sharp blade/crescent blade. Bleeding wilbe controlled with pressure from cotton buds. The area of conjunctival defect will be measured with a caliper and a conjunctival limbal autograft measuring the same size as the defect will be obtained from the supertemporal quadrant of the bulbar conjunctiva. The graft will be flipped over the cornea and brought near the area of bare sclera formed by excision of the pterygium. Proper orientation will be maintained while placing the graft.
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having either any one of the clinical features of chedana sadya arma such as charmabha bahala snayu mamsaghanaavrutta krushnamandalaga. Controlled diabetic and hypertensive. Patients willing to come for follow up of 6 months 
 
ExclusionCriteria 
Details  Lekhana Sadya Arma. Recurred Pterygium. Subjects having any inflammatory diseases of the eye. Subjects suffering from any of the systemic disorders. Pregnant women and lactating mothers.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To prevent the recurrence of pterygium  220 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the redness foreign body sensation and watering of eye  40 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   05/05/2025 
Date of Study Completion (India) 06/05/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 06/05/2026 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Arma is one among Shuklagatha Roga which is characterized by gradually spreading fleshy growth occurring in the Shukla mandala. Based on the bheda, varna, and dosha involved, Arma is classified into 5 types i.e., Prastari Arma, Shukla Arma, Kshataja/Lohita Arma, Adhimamsa Arma, and Snayu Arma. The anatomical understanding of the Shukla mandala and the symptoms of Arma suggest a comparison to Pterygium. In contemporary, Pterygium is a wing-shaped fold of conjunctiva encroaching upon the cornea from either side within the interpalpebral fissure. The main treatment for pterygium is surgical removal, which has to be taken into consideration in case of reduced visual acuity due to visual axis involvement, induced astigmatism, or frequent inflammation and discomfort. The prevalence rate of pterygium in the total population of India was 10%.

The treatment principles explained in the classics for Arma, Chedana followed by Lekhana Anjana is considered to be more effective. In Chedana procedure the excessive growth in the Shukla mandala is excised. “Nayanasukha varti” a medicine mentioned in the management of Arma in Bhaishajyaratnavali, Contains the Drugs having Lekhana, Chakshushya, Vranaropaka, Rasayana and Tridoshahara Properties.

Pterygium surgery is concerned by postoperative recurrence whose rate can be 24% to 89% and its severity may vary according to the adopted approach and preoperative conditions because fibrovascular growth may occur also with greater extension than its primary presentation. To reduce the recurrence rate advanced techniques have been adopted such as Conjunctival Autografting, Mitomycin C application, and Amniotic membrane graft. Conjunctival limbal autograft (hereafter referred to as "conjunctival autograft") involves removing limbal tissue and adjacent conjunctiva in one piece from another part of the person’s eye and using the tissue to cover the area from which the pterygium was excised. Recurrence of pterygium at three months after surgery ranged up to 16.7% in the conjunctival autograft. The postoperative complications observed included conjunctival encroachment over the graft, small graft, graft dislodging, thick graft, improper position, graft edema, ocular surface exposure, progressive horizontal conjunctivalization, and pyogenic granuloma.

Hence, to overcome the above complications, cost efficiency and effectiveness this study is undertaken to evaluate the effect of Nayanasukha varti Anjana in the prevention of the recurrence of Arma following the arma chedana karma. In this study the control group is conjunctival autografting following Arma Chedana in the prevention of recurrence of Arma.

 
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