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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:H111||Conjunctival degenerations and deposits. Ayurveda Condition: PRASTARI-ARMA, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Classical | | (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 | 2 | Intervention Arm | Drug | Classical | | (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 vyadhi. Marichanjanaand 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. |