| CTRI Number |
CTRI/2022/05/042345 [Registered on: 02/05/2022] Trial Registered Prospectively |
| Last Modified On: |
01/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of Erand mul arka eye drop on simple allergic conjunctivitis. |
|
Scientific Title of Study
|
Randomized controlled trial of Eranad mul arka eye drop with Olopetadine 0.1% eye drop in Vataj Abhishand W.S.R simple allergic conjunctivitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIivek P Harne |
| Designation |
MS Shalakyatantra scholar |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Center |
| Address |
Department of Shalakya tantra Opd Dr D Y Patil College Of Ayurveda And Research Center Sant Tukaram Nagar Pimpri Pune Pune MAHARASHTRA 411018 India
Department of Shalakya tantra Opd Dr D Y Patil College Of Ayurveda And Research Center Sant Tukaram Nagar Pimpri Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
8530094441 |
| Fax |
|
| Email |
dr.vivekharne15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Pallavi Jagtap |
| Designation |
prof of Shalakya tantra |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Center |
| Address |
Department of Shalakya tantra Opd Dr D Y Patil College Of Ayurveda And Research Center Sant Tukaram Nagar Pimpri Pune Pune MAHARASHTRA 411018 India
Department of Shalakya tantra Opd Dr D Y Patil College Of Ayurveda And Research Center Sant Tukaram Nagar Pimpri Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
8983535924 |
| Fax |
|
| Email |
pallavibhor78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vivek P Harne |
| Designation |
MS Shalakyatantra scholar |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Center |
| Address |
Department of Shalakya tantra Opd Dr D Y Patil College Of Ayurveda And Research Center Sant Tukaram Nagar Pimpri Pune Pune MAHARASHTRA 411018 India
Department of Shalakya tantra Opd Dr D Y Patil College Of Ayurveda And Research Center Sant Tukaram Nagar Pimpri Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
8530094441 |
| Fax |
|
| Email |
dr.vivekharne15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College Of Ayurveda And Research Center |
|
|
Primary Sponsor
|
| Name |
Vivek P Harne |
| Address |
Dr D Y Patil College Of Ayurveda And Research Center Sant Tukaram Nagar Pimpri Pune |
| 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 |
| Vivek P Harne |
Dr D Y Patil Ayurved Hospital Pimpri |
OPD and IPD of Dr D Y Patil Ayurved Hospital Pimpri
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8530094441
dr.vivekharne15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H103||Unspecified acute conjunctivitis. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Olopetadine 0.1 % | medicine name Olopetadine 0.1 % | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Erand Mul. Arka , Reference: bhaishayjya ratnavali, sharandhar samhita, Route: Topical, Dosage Form: Arka, Dose: 2(drops), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Both male and female
2) Between the age group of 18 to 60 yrs will be included in the study.
3) Patient suffering from Toda (pricking pain), Sangharsh (foreign body sensation), Vishushk Bhav (dryness feeling), Shishirasruta (cline/watery discharge), Alpashopha (mild chemosis) will be selected irrespective of their sex, education, socio economic status & religion.
|
|
| ExclusionCriteria |
| Details |
1) Patient not willing for trial
2) Pregnant & lactating women.
3) Patient who need surgical and other in intervention.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
to see effect of Erand Mul Arka Eye drop and Olopetadine 0.1 % Eye drop in Vataj Abhi Shyand (simple allergic conjunctivitis) To review ancient literature on Vataj Abhi Shyand (simple allergic conjunctivitis)
|
7th and 15th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
evidence base support for the effect of Erand Mul Eye Drop as mentioned in our ancient literature
provide simple and effective treatment for Vataj Abhi Shyand (simple allergic conjunctivitis)
|
throught study for 15 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/05/2022 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of study is compare effect of Erand Mul. Arka Eye drop in management of Vataj Abhi Shyand (simple allergic conjunctivitis) with OLOPETADINE 0.1% EYE DROP IN VATAJ ABHISHAND W.S.R SIMPLEALLERGIC CONJUNCTIVITIS†total 60 patients will recive treatment in group A 30 and group B 30 . Group A recive Erand mul eye drop 2 drops thrice a day for 15 days . Group B recive Olopetadin 0.1 % Eye drop for 15 days. Data will be assed on the basis of subjective and objective parameters . conclusion will be drawn on the the basis of statistical analysis . |