| CTRI Number |
CTRI/2017/04/008334 [Registered on: 12/04/2017] Trial Registered Prospectively |
| Last Modified On: |
11/04/2017 |
| 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
|
Ayurvedic management of Dry eye syndrome. |
|
Scientific Title of Study
|
"Efficacy of Dashamuladhya ghrita along with Mridweekaadi eye drops and Nayanamrita eye ointment on Shushkaakshipaka(Dry eye syndrome)-An open label,Randomized,Comparative,Clinical trial". |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D B vaghela |
| Designation |
Associate proffessor |
| Affiliation |
ipgt & ra gau |
| Address |
Gujarat Ayurved University Jamnagar
GUJARAT 361008 India Department of Shalakyatantra IPGT AND RA Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
Gujarat Ayurved University Jamnagar
GUJARAT 361008 India Department of Shalakyatantra IPGT AND
RA Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D B vaghela |
| Designation |
Associate proffessor |
| Affiliation |
ipgt & ra gau |
| Address |
Gujarat Ayurved University Jamnagar
GUJARAT 361008 India Department of Shalakyatantra IPGT AND
RA Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
Gujarat Ayurved University Jamnagar
GUJARAT 361008 India Department of Shalakyatantra IPGT AND
RA Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D B vaghela |
| Designation |
Associate proffessor |
| Affiliation |
ipgt & ra gau |
| Address |
Gujarat Ayurved University Jamnagar
GUJARAT 361008 India Department of Shalakyatantra IPGT AND
RA Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
Gujarat Ayurved University Jamnagar
GUJARAT 361008 India Department of Shalakyatantra IPGT AND
RA Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA GUJARAT AYURVED UNIVERSITY |
| Address |
IPGT AND RA GUJARAT AYURVED UNIVERSITY OPPOSITE
CITY B DIVISION POLICE STATION PN MARG JAMNAGAR |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| ashok kumar |
IPGT&RA |
IPGT&RA
GAU
OPD no 4 and reffered from other dept of IPGT&RA
jamnagar
Jamnagar
GUJARAT |
9587836164
ashokkumar17061989@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 |
patient having sign and symptoms of dry eye syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A intervention
mridweekaadi eye drop with nayanamrita eye ointmaent with dashamuladhya ghrita orally
Group B comparator
mridweekaadi eye drop and nayanamrita eye ointment |
Group A intervention
mridweekaadi eye drop 1drop QID
nayanamrita eye ointmaent 60mg HS and dashamuladhya ghrita 10 gm HS orally.
Group B comparator
mridweekaadi eye drop 1drop QID and nayanamrita eye ointment 60mg HS |
| Comparator Agent |
group B |
mridweekaadi eye drop 1drop QID and nayanamrita eye ointment 60 mg HS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
sign and symptoms of dry eye syndrome
willing and able to participate in the study |
|
| ExclusionCriteria |
| Details |
severe case of dry eye syndrome with complications
allergic eye disease
non specific topical beta blocker users |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease of dry eye symptoms |
decrease of dry eye symptoms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efficacy of ayurvedic drugs |
nov2017 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
18/04/2017 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nothing till now |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
dry eye syndrome presenting with irritation feeling of dryness burning sensation. In present trail comparision between two groups one groups with mridweekadi eye drops and nayanaamrit eye ointment and another one with same drugs along with dashamuladhya ghrita . |