| CTRI Number |
CTRI/2025/03/083268 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To examine the effect of Karanja Beeja Varti Anjan application in 84 participants (both male and female) of age group between 18 to 55 years with signs of progressive pterygium. |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of Karanja Beej Varti Anjan 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 Manasi Surendra Karjini |
| Designation |
B.A.M.S. PG Scholar (Shalakyatantra) |
| Affiliation |
LKR Ayurvedic Mahavidyalaya Post Graduate Training and Research Center, Gadhinglaj, Kolhapur |
| Address |
Shalakyatantra OPD no. 49, 1st floor, LKR Hospital, P2 MIDC Area, Shendri Mal, Gadhinglaj, Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9969403114 |
| Fax |
|
| Email |
manasikarjini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra Kolachi |
| Designation |
B.A.M.S. M. S. Shalakyatantra |
| Affiliation |
LKR Ayurvedic Mahavidyalaya Post Graduate Training and Research Center, Gadhinglaj, Kolhapur |
| Address |
Shalakyatantra OPD no. 49, 1st floor, LKR Hospital, P2 MIDC Area, Shendri Mal, Gadhinglaj, Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9972616774 |
| Fax |
|
| Email |
ayurraga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manasi Surendra Karjini |
| Designation |
B.A.M.S. PG Scholar (Shalakyatantra) |
| Affiliation |
LKR Ayurvedic Mahavidyalaya Post Graduate Training and Research Center, Gadhinglaj, Kolhapur |
| Address |
Shalakyatantra OPD no. 49, 1st floor, LKR Hospital, P2 MIDC Area Shendri Mal, Gadhinglaj, Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9969403114 |
| Fax |
|
| Email |
manasikarjini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Manasi Surendra Karjini |
| Address |
A-1/4, Old Best Nagar, Gajanan Maharaj Marg, Goregaon West, Mumbai 400104. |
| 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 Manasi Surendra Karjini |
LKR Ayurvedic Mahavidyalaya Post Graduate Training and Research Centre |
Shalakyatantra OPD no. 49, 1st floor, LKR Hospital, P2 MIDC Area, Shendri Mal, Gadhinglaj, Kolhapur 416502.
Kolhapur
MAHARASHTRA |
9969403114
manasikarjini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| L.K.R. Ayurvedic Mahavidyalaya Post Graduate Training and Research Center, Gadhinglaj, Kolhapur |
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 | Drug | Classical | | (1) Medicine Name: Karanja Beeja Varti , Reference: Sharangdhar Samhita Uttarkhand Adhyaya 13/78 , Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: Varti will be rubbed with water and application of Anjan will be done daily. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chandrodaya Varti , Reference: Bhaishajya Ratnawali Adhyaya 64 Netrachikitsa Adhyaya 189 to 192, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: Varti will be rubbed with water and application of Anjan will be done daily. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Lakshanas of Aushadhi Sadhya Arma.
Patients with pterygium type I extending up to 2mm on the cornea. |
|
| ExclusionCriteria |
| Details |
Patients with pterygium and associated with other ocular conditions will be excluded from study.
Patients with Chhedya and Asadhya arma will be excluded.
Those who are suffering from serious illness like Cardiac Disorders, HIV, TB, Leprosy,Cancer, Diabetes mellitus, Asthma, Renal Impairments, Hepatitis and those who are on Immune Suppressive drugs will be excluded from the study.
Pregnant and nursing mothers are excluded from study. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of Karanja Beej Varti Anjan in Prastari Arma. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse reaction if any. |
21 days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
03/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a single blind randomized controlled clinical study to evaluate the efficacy of Karanja Beej Varti Anjan in Prastari Arma.
total 84 patients of age 20 to 55 years of both sex will be randomly selected for this trial and divided into two groups.
Group A Treated with Karanja Beej Varti Anjan.
Dose (20 to 55 years) one harenu matra in eyes for 21 days.
Group B Treated with Chandrodaya Varti Anjan.
Dose (20 to 55 years) one harenu matra in eye for 21 days.
Data will be analysed and appropriate statistical tests will be applied. |