| CTRI Number |
CTRI/2025/06/088689 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
CLINICAL
EFFICACY OF BILVADYA ASHCHYOTANA AND ERANDA MOOLADI
KSHEERA PAKA ASHCHYOTANA IN THE MANAGEMENT OF VATAJA
ABHISHYANDA WITH SPECIAL REFERENCE TO SIMPLE ALLERGIC CONJUNCTIVITIS |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL TRIAL TO EVALUATE CLINICAL
EFFICACY OF BILVADYA
ASHCHYOTANA AND ERANDA MOOLADI
KSHEERA PAKA ASHCHYOTANA IN THE MANAGEMENT OF VATAJA
ABHISHYANDA WITH SPECIAL REFERENCE TO SIMPLE ALLERGIC CONJUNCTIVITIS |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shital Laxmanrao pawar |
| Designation |
PG SCHOLAR |
| Affiliation |
Sst Ayurved College |
| Address |
Sst Ayurved Mahavidyalaya, shalakyatantra opd,room no.3 ,infront of prasad hotel , sangamner ,ahmadnagar,maharashtra
Sst Ayurved mahavidyalaya Shalakyatantra Opd and ipd, infront of prasad hotel sangamner , ahmadnagar maharashtra
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9112321882 |
| Fax |
|
| Email |
pawarshital592@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anil Sugandhrao Deshmukh |
| Designation |
Guide and Hod |
| Affiliation |
Sst Ayurved mahavidyalaya Sangamner ahmadnagar |
| Address |
Sst Ayurved Mahavidyalaya Shalakyatantra department, Sangamner, ahmadnagar maharashtra
Visava building deshmukh hospital,pune nashik highway,Sangamner, ahmadnagar maharashtra
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9822262627 |
| Fax |
|
| Email |
ranwaraanil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shital Laxmanrao Pawar |
| Designation |
Pg scholar |
| Affiliation |
Sst Ayurved College Sangamner ahmadnagar |
| Address |
Sst Ayurved Mahavidyalaya Shalakyatantra Opd , room no.3,infront of prasad hotel sangamner ahmadnagar maharashtra
Sst Ayurved College Girls Hostel infront of prasad hotel sangamner ahmadnagar maharashtra
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9112321882 |
| Fax |
|
| Email |
Pawarshital592@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sst Ayurved Mahavidyalaya Sangamner |
| Address |
Sst Ayurved Mahavidyalaya, infront of prasad hotel,Sangamner pune nashik h ighway, ahmadnagar ,maharashtra ,india 422605 |
| Type of Sponsor |
Private medical college |
|
|
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 shital Laxmanrao Pawar |
Sst Ayurved College |
Sst Ayurved hospital Shalakyatantra Opd room no.3,infront of prasad hotel pune nashik highway sangamner ahamadnagar
Ahmadnagar
MAHARASHTRA |
9112321882
Pawarshital592@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: H10, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Eranda mooladi ksheera paka aschyotana , Reference: Bhaishajya ratnavali 64/16, Route: Ocular, Dosage Form: Ksheerpaka, Dose: 10(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilvadya aschyotana , Reference: Bharat bhaishjya ratnakar part 3 4590, Route: Ocular, Dosage Form: Kwatha/ Kashaya, Dose: 10(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -drug will be prepared as per samhita |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 16 years to 60 years of age.
2. Patients presenting with typical signs and symptoms of Vataja
Abhishyanda (Simple Allergic Conjunctivitis) within eye i.e., Nistoda
(Pricking Pain), Sangharsha (Foreign body sensation), Ragata
(Redness), Vishushka Bhava (Dryness feeling), Achchashruta
(Clean/Watery discharge), Alpa Shopha (Mild Chemo-sis), Chala Ruja
(Intermittent pain), Kandu (Itching), Daha (Burning sensation |
|
| ExclusionCriteria |
| Details |
Patients having complications like corneal involvement like
Marginal Corneal Ulcer, Dacryocystitis, Trachoma,
Keratoconjunctivitis sicca, Vernal keratoconjunctivitis, Giant
papillary conjunctivitis, Atopic keratoconjunctivitis.
2. All types of Conjunctivitis (Acute and Chronic) which are non-allergic
in nature are excluded from the Study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduce sign and symptoms of Vataja Abhishyanda w.s.r. to Simple
Allergic Conjunctivitis. |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
No recurrence of Vataja abhishyanda w.s.r to simple Allergic
Conjunctivitis. |
5 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
23/06/2025 |
| 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
|
As we see the number of patients suffer with conjunctivitis are mainly because of allegens they are in get contact with, So to know ,compare efficacy of bilvadya ashchyatana and arand mooladi ksheerpaka aschyotana in simple allergic conjunctivitis , Both drugs are used in the form of aschyotana for diagnosed cases of simple allergic conjunctivitis for 5 days , 40 patients in each group studied, study will be conducted in india, outcome of study will be asses on reducing symptoms like itching, foreign body sensation, lacrimation . |