| CTRI Number |
CTRI/2024/03/064036 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
compare effect of Nayansukhavarti Anjana and Rasanjana in Pterygium |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of nayansukhavarti anjana and rasanjana in prastari arma with special reference to progressive 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 Prarthana Pandurang Patil |
| Designation |
Post Graduate Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD NO 2 Netra Rog OPD Ground floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9545791139 |
| Fax |
|
| Email |
patilprarthu03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayvant Vasant Kharat |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
Second Floor Department of Shalakya Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9604010037 |
| Fax |
|
| Email |
jayvantkharat55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayvant Vasant Kharat |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
Second Floor Department of Shalakya Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9604010037 |
| Fax |
|
| Email |
jayvantkharat55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon shri Annasaheb Dange Ayurved Medical college Post Graduate and Research Center Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Prarthana Pandurang Patil |
| Address |
OPD NO 2 Netra Rog OPD Ground floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli |
| Type of Sponsor |
Other [Nill] |
|
|
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 Prarthana Pandurang Patil |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
OPD NO 2 Netra Rog OPD Ground floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
9545791139
patilprarthu03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H110||Pterygium of eye. Ayurveda Condition: PRASTARI-ARMA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: shusruta samhita, Procedure details: once in day for 15 days)
(1) Medicine Name: Rasanjana, Reference: Ayurved Prakash, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 40(mg), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: Shushruta samhita, Procedure details: Once in a day for 15 days)
(1) Medicine Name: Nayansukhvarti anjana, Reference: Chkradatta, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 40(mg), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient which shows sign and symptoms of Prastari Arma
2 Pterygium, both from inner and outer canthus
3 Pterygium limited to scleral part (up to Limbus) only
4 Patient irrespective of Gender educational status socio economical status marital statuscaste Religion Race etc
|
|
| ExclusionCriteria |
| Details |
1 Any acute infective ocular disease
2 Recently operated eye
3 Pterygium encroaching cornea
4 Patient having major complicated systemic and eye disease
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of nayansukhavarti anjana and rasanjana in prastari Arma |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of nayansukhavarti anjana & rasanjana in prastari Arma |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
04/04/2024 |
| 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="6"
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
|
As we see the number of patients with Prastari Arma increasing now a days so this study will help the patients to relieve the symptoms by the exertion of Doshas and cheaper than surgical treatment and easily available this study is comparitve clinical open trial The efficacy of Nayansukhavarti Anjana and Rasanjana will be compared in the mangement of Prastari Arma with special reference to Progressive Pterygium 41 patients will be selected in each group Group A patients will be treated with Nayansukhavarti Anjana and Group B will be trated with Rasanjana Procedure will be done once in a day for 15 days follow up will be done on with treatment 7th 14th and without treatment 21th 30th days Study will be conducted in India outcome of study will be assessed on basis of Slit Lamp examination and Castroviejo Caliper and reduction of signs and symptoms of Progressive Pterygium will be noted |