| CTRI Number |
CTRI/2020/04/024696 [Registered on: 16/04/2020] Trial Registered Prospectively |
| Last Modified On: |
07/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, nagaradi eye drops and vachaharidradi application in patients with allergic conjuctivitis |
|
Scientific Title of Study
|
A comparative study of nagaradi aschyotana and vachaharidradi vidalaka in the management of kaphaja abhishyanda (simple allergic conjuctivitis) |
| Trial Acronym |
NAVV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenu P R |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of Shalakya Tantra
3rd floor
Alvas Ayurveda Medical College and Hospital
Moodbdri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8547392951 |
| Fax |
|
| Email |
meenupraphul92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Kumar K |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of Shalakya Tantra
3rd floor
Alvas Ayurveda Medical College and Hospital
Moodbdri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9986576898 |
| Fax |
|
| Email |
drpradeepkayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar K |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of Shalakya Tantra
3rd floor
Alvas Ayurveda Medical College and Hospital
Moodbdri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9986576898 |
| Fax |
|
| Email |
drpradeepkayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakya Tantra
3rd floor
Alvas Ayurveda Medical College and Hospital
Moodbdri |
|
|
Primary Sponsor
|
| Name |
Dr Meenu P R |
| Address |
Rakendhu(ho) Vattoli bazar(po)
Calicut Kerala
673612 |
| 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 Meenu P R |
Alvas Ayurveda Medical College and Hospital |
Shalakya OPD Department of Shalakya Tantra Room number 3 Ground floor Vidyagiri Moodbidri
Dakshina Kannada
KARNATAKA |
8547392951
meenupraphul92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee Alvas Ayurveda Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H108||Other conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nagaradi Aschyotana |
8 drops of medicine should be instilled to the eye twice daily for 7 days |
| Comparator Agent |
Vachaharidradi Vidalaka |
Quantity sufficient medicine should be applied around the eye twice daily for 7 days |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 5 years
Patients presenting with clinical features of Kaphaja Abhishyanda(Simple allergic conjunctivitis) will be selected
|
|
| ExclusionCriteria |
| Details |
Patients having other types of Conjuctivitis, Marginal corneal ulcer, Dacryocystitis and other ocular manifestations
Patients suffering with systemic disorders
Patients having genetic predisposition to allergy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Watering of eye
2.Itching
3.Burning sensation
4.Congestion of bulbar and palpebral conjuctiva
5.Chemosis
6.Papillary reaction
7.Foreign body sensation
|
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
http://www.ncbi.nlm.nih.gov/ |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized open label parallel group single centre trial comparing efficacy of Nagaradi Aschyotana and Vachaharidradi Vidalaka for 7 days in 40 patients with Kaphaja Abhishyanda that will be conducted in Alvas Ayurveda Medical College Vidyagiri Moodbidri Dakshin Kannada.Primary outcome measures will be Watering of eye, Itching, Burning sensation, Foreign body sensation, Congestion of bulbar and palpebral conjuctiva, Chemosis and Papillary reaction in 21 days |