| CTRI Number |
CTRI/2025/07/090941 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of anajana in pterygium (Arma) |
|
Scientific Title of Study
|
An open label double arm controlled clinical study of Shankanjana in Arma( 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. Manoj M C |
| Designation |
Postgraduate scholar |
| Affiliation |
SDM institute of Ayurveda college and Hospital |
| Address |
Room no- 10, Department of Shalakya tantra, SDM institute of Ayurveda college and Hospital, Shalakya tantra department,opd-10,Anchepalya, Bengaluru-560074
Room no- 10, Department of Shalakya tantra, SDM institute of Ayurveda college and Hospital, Shalakya tantra department,opd-10,Anchepalya, Bengaluru-560074
Bangalore
KARNATAKA
560074
India |
| Phone |
8884596148 |
| Fax |
|
| Email |
drmanojmc@sdmayurbangalore.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharan prasad Kolliyavar |
| Designation |
Associate professor |
| Affiliation |
SDM INNSTITUTE OF AYURVEDA COLLEGE AND HOSPITAL |
| Address |
ROOM NO- 10, Department of shalakya tantra, SDM INNSTITUTE OF AYURVEDA COLLEGE AND HOSPITAL, ANCHEPALYA, BENGALURU-74
Bangalore
KARNATAKA
560074
India |
| Phone |
9844897784 |
| Fax |
|
| Email |
drsharanprasad.k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharan prasad Kolliyavar |
| Designation |
Associate professor |
| Affiliation |
SDM INNSTITUTE OF AYURVEDA COLLEGE AND HOSPITAL |
| Address |
ROOM NO- 10, Department of shalakya tantra, SDM INNSTITUTE OF AYURVEDA COLLEGE AND HOSPITAL, ANCHEPALYA, BENGALURU-74
KARNATAKA
560074
India |
| Phone |
9844897784 |
| Fax |
|
| Email |
drsharanprasad.k@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM institute of Ayurveda college and Hospital,Anchepalya, Bengaluru,-560074 |
|
|
Primary Sponsor
|
| Name |
Dr Manoj M C |
| Address |
SDM Institue of Ayurveda college and Hospital, Anchepalya, Bengaluru-74 |
| 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 Manoj M C |
SDM Institute of Ayurveda and Hospital,Bengaluru |
Room no-10,11,16, Department of shalakya tantra, SDM Institute of Ayurveda and Hospital,Bengaluru- 560074
Bangalore
KARNATAKA |
8884596148
drmanojmc@sdmayurbangalore.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DHARMASTHALA MANJUNATHESHWARA INSTITUTE OF AYURVEDA AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H110||Pterygium of eye. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHANKANJANA, Reference: CHIKITSA MANJARI, Route: Topical, Dosage Form: Bhasma, Dose: 60(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: GUDUCHYADI RASAKRIYANJANA, Reference: SHARANGADHARA SAMHITHA, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 30 to 60 years of either gender will be selected.
2. Patients having the classical Lakshanas of Arma will be selected.
3. Encroaching of Pterygium limited to corneal margins.
4. Pterygium with both unilateral and bilateral will be considered.
|
|
| ExclusionCriteria |
| Details |
1.Patients with Autoimmune diseases that has caused Pterygium.
2.Pterygium with any other ocular pathologies.
3.Pseudopterygium and Pinguecula.
4.Patients with Chedhana yogya Arma as explained in classical text will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOME MEASURE
1. Improvement in the Subjective parameters
2. Decrease in Length and Width of the Arma.
SECONDARY OUTCOME MEASURES:
1. Sustained effect of treatment on Subjective Parameters
2. To develop easily approachable cost-effective treatment.
|
45 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY OUTCOME MEASURES:
1. Sustained effect of treatment on Subjective Parameters
2. To develop easily approachable cost-effective treatment.
|
45 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/07/2025 |
| 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="5"
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
|
In
modern science patient have to undergo excision of pterygium and mostly bare
sclera surgical technique is accepted having high rate of recurrence, while
topical medications only can temporarily subside the symptoms and disease may
produce cosmetic problems, significant astigmatism and visual impairment or Blindness. In Ayurveda, before Arma
encroaches Krishnamandala acharyas have explained many treatment modalities like Lekhana
Anjana and many researches have proved its benefits in treating many cases
successfully. Among them Guduchyadi rasakriyanjana which
is having properties like Rukshata,
Lekhana, Sukshma, Tikshna, Vyavayi, Vikasi, Rasayana which has already proved its efficacy is
taken as control group.Shankhanjana possessing the properties like Kshariya,sheeta , Laghu,Ruksha guna which facilitates the actions on Arma as
Lekhananjana is taken for the present study as trial group. |