| 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 |
|
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Primary Sponsor
|
| Name |
Dr NITHIN V |
| Address |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College & Hospital, Koppal 583231 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Comparator Arm (Non Ayurveda) | | - | Conjunctival autografting | Superior 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. |
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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.
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Open Label |
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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 |
|
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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
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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. |