| CTRI Number |
CTRI/2017/06/008746 [Registered on: 02/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of Ayurvedic Eye Drops with Antibiotic Eye Drops for conjunctivitis. |
|
Scientific Title of Study
|
Role of Nimbadi eye drops in Netrabhishyanda in the special reference to infective conjunctivitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RUBY |
| Designation |
PhD Scholar |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Shalakya Tantra,
Faculty of Ayurveda,
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8210002352 |
| Fax |
|
| Email |
dr.rubybhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj Kumar |
| Designation |
Guide for PG Thesis and Associate Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Shalakya Tantra,
Faculty of Ayurveda,
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8210002352 |
| Fax |
|
| Email |
mkumarbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RUBY |
| Designation |
PhD Scholar |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Shalakya Tantra,
Faculty of Ayurveda,
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8210002352 |
| Fax |
|
| Email |
dr.rubybhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
RUBY |
| Address |
Department of Shalakya Tantra,
Faculty of Ayurveda,
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi-221005, India |
| Type of Sponsor |
Other [University] |
|
|
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 |
| RUBY |
Institute of Medical Sciences |
OPD (Room No. 13)Department of Shalakya Tantra,and OPD (Room No 7of Department of Ophthalmology,Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH |
8210002352
dr.rubybhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Infective Conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Levofloxacin 0.5% eye drops |
2 drops, four times in a day for 10 days |
| Intervention |
Nimbadi eye drops (Ayurvedic formulation) |
2 drops, four times in a day for 10 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with at least 12 years of age and having clinical diagnosis of infective conjunctivitis at least in one eye. |
|
| ExclusionCriteria |
| Details |
Patients with any concomitant disease of eye which could interfere with assessment of infective conjunctivitis (Netrabhishyanda) such as anterior uveitis, scleritis, episcleritis etc. were excluded from the study
Patients who develop any complication during the trial will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in scores of symptoms and signs of infective conjunctivitis |
Day 2, Day 5, Day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in scores of symptoms and signs of infective conjunctivitis |
Day 2, Day 5, Day 10 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/09/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study has been planned to evaluate the efficacy of Nimbadi eye drops on symptoms and signs
of Infective Conjunctivitis (Netrabhishyanda) as compared to Levofloxacin 0.5%
ophthalmic solution on 30 patients of infective conjunctivitis. It has been planned to assess the disease condition on clinical basis.
|