| CTRI Number |
CTRI/2025/05/086523 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of haritakyadi varti anjana in the management of kaphaj abhishyanda |
|
Scientific Title of Study
|
Randomised control clinical trial to evaluate the efficacy of haritakyadi varti anjana in kaphaj abhishyanda with special referance to acute mucopurulent 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 |
Dipali Dilip Rupnar |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurved Medical College and Hospital,Post Graduate Institute and Reasearch Centre,Islampur. |
| Address |
OPD No.11,Shalakyatantra Department,Lokanete Rajarambapu Patil Ayurved Medical College and Hospital, Post Graduate Institute and Reasearch Centre,Urun Islampur,Tal- Walwa,Dist- Sangli
LRP Ayurved Medical College and Hospital, Post Graduate Institute and Reasearch Centre,Urun Islampur,Tal- Walwa,Dist- Sangli,415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
7083934472 |
| Fax |
|
| Email |
dipalirupnar53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Walvekar |
| Designation |
Asso. Professor |
| Affiliation |
LRP Ayurved Medical College and Hospital,Post Graduate Institute and Reasearch Centre,Islampur. |
| Address |
OPD No.11,Shalakyatantra Department, Lokanete Rajarambapu Patil Ayurved Medical College and Hospital, Post Graduate Institute and Reasearch Centre,Urun Islampur,Tal- Walwa,Dist- Sangli
LRP Ayurved Medical College and Hospital, Post Graduate Institute and Reasearch Centre,Urun Islampur,Tal- Walwa,Dist- Sangli,415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822442719 |
| Fax |
|
| Email |
sunilwalvekar99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dipali Dilip Rupnar |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurved Medical College and Hospital,Post Graduate Institute and Reasearch Centre,Islampur. |
| Address |
OPD No.11,Shalakyatantra Department,Lokanete Rajarambapu Patil Ayurved Medical College and Hospital, Post Graduate Institute and Reasearch Centre,Urun Islampur,Tal- Walwa,Dist- Sangli
LRP Ayurved Medical College and Hospital, Post Graduate Institute and Reasearch Centre,Urun Islampur,Tal- Walwa,Dist- Sangli,415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
7083934472 |
| Fax |
|
| Email |
dipalirupnar53@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurved Mahavidyalay and Hospital ,PG Institute and Research Centre, Urun Islampur415409 |
|
|
Primary Sponsor
|
| Name |
Dipali Dilip Rupnar |
| Address |
OPD No.11,Lokanete Rajarambapu Patil Ayurved Medical College and Hospital, Post Graduate Institute and Reasearch Centre,Islampur,Tal- Walwa,Dist- Sangli |
| 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 Dipali Dilip Rupnar |
LRP Ayurvedic Medical Collegeand Hospital, PG Institute andResearch Centre,Urun Islampur. |
OPD No.11,Shalakyatantra Department,Lokanete Rajarambapu Patil Ayurved Medical College and Hospital, Post Graduate Institute and Reasearch Centre,Urun Islampur,Tal- Walwa,Dist- Sangli,415409
Sangli
MAHARASHTRA |
7083934472
dipalirupnar53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC LRP Ayurvedic Medical College and Hospital, PG Institute and Research Centre, Islampur. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H100||Mucopurulent conjunctivitis. Ayurveda Condition: KAPABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi Varti Anjana , Reference: Sushrut Uttartantra 11/7, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Moxifloxacin Eye Drop | Moxifloxacin hydrochloride ophthalmic solution 0.5% is the ocular formulation of moxifloxacin.It is a broad spectrum 8-methoxyfluoroquinolone which terminates bacterial growth bt binding to DNA gyrase and topoisomerase5
Contains- Active Moxifloxacin 0.5%(5 mg/ml),inactive boric acid, sodium chloride and purified water. |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients showing classical sign and symptoms of Kaphaj Netra Abhishyanda
2.Patients irrespective of sex, occupation and socio economic status will be selected |
|
| ExclusionCriteria |
| Details |
1.Patients of age group below 16 years and above 50 years
2.Patients with other ocular diseases
3.Recently eye operated patients
4.Patients with other major systemic diseases
5.Using any other eye medication
6.Patients with sever complaints will exclude |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Haritakyadi varti anjana in the management of Kaphaj Abhishyanda. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the detail literature about Kaphaj Abhishyanda
2.To study the detail literature about Acute Mucopurulent Conjunctivitis.
3.To study the effect of Haritakyadi Varti Anjan in Kaphaj Abhishyanda. |
5 TO 15 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 3 |
|
Date of First Enrollment (India)
|
20/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="2" |
|
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
|
Aim - To evaluate the efficacy of Haritakyadi Varti Anjana in Kaphaj Abhishyanda with special referance to Acute Mucopurulent Conjunctivitis.
Primary Objective - To study efficacy of Hritakyadi Varti Anjana in Kaphaj Abhishyanda with special referance acute mucopurulent conjunctivitis.
Secondary Objective - To study the detail literature about Kaphaj Abhishyanda. To study the detail literature about acute mucopurulent conjunctivitis To study the effect of Haritakyadi Varti Anjana in Kaphaj Abhishyanda with special referance to Acute Mucopurulent Conjunctivitis.
Type of study design - Double Arm Clinical Study , Open study
Study setting - Patients having symptoms related to Kaphaj Abhishyanda will be registered from the Shalakya OPD in our hospital.
Study Population - 80
Duration of Treatment - 5 Days
Overall Duration of Study - 18 months
Follow up - 1st, 3rd, 5th, 7th, 15th Day
Diagnostic criteria -
Patients will be diagnosed on the basis of clinical signs and symptoms.
Assessment Criteria -
Subjective parameters are based on symptomatic relief i.e - Netra Kandu , Photophobia
The data obtained will be analyzed statistically.
Observation and Result - The obtained Clinical efficacy of treatment will be observed and recorded.
Discussion - On the basis of collection of data discussion will be done
Conclussion - Conclussion will be done on the basis of statistical significant i.e as per obtained result and observation the clinical study will be discussed.
Summary - The research study will be summarized in brief.
Ethical consideration - The study will be conducted in accordance with ethical guidelines and inform concent from participants. |