CTRI

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CTRI Number

CTRI/2018/03/012530 [Registered on: 13/03/2018] Trial Registered Prospectively

Last Modified On:

13/03/2018

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Process of Care Changes

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

Whether herbal eye drops help in management of dry eye syndrome ?

Scientific Title of Study

"Role of Rajnidaaru eye drops and Rasayan Churna in the management of Shushkaakshipaka (Dry eye syndrome) - An open label double arm randomized clinical trialâ€

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Neeraj Dubey
Designation	P.G. Scholor
Affiliation	All india institue of ayurveda
Address	OPD No-101 1 st floor, Hospital Block ,All India Institute of Ayurveda Department of Shalakya Tantra,Gautampuri,Sarita Vihar,New Delhi South West DELHI 110076 India
Phone
Fax
Email	dubenrj@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Neeraj Dubey
Designation	P.G. Scholor
Affiliation	All india institue of ayurveda
Address	OPD No-101 1 st floor, Hospital Block ,All India Institute of Ayurveda Department of Shalakya Tantra,Gautampuri,Sarita Vihar,New Delhi South West DELHI 110065 India
Phone	8285520530
Fax
Email	dubenrj@gmail.com

Details of Contact Person
Public Query

Name	Dr Neeraj Dubey
Designation	P.G. Scholor
Affiliation	All india institue of ayurveda
Address	OPD No-101 1 st floor, Hospital Block ,All India Institute of Ayurveda Department of Shalakya Tantra,Gautampuri,Sarita Vihar,New Delhi South West DELHI 110065 India
Phone	8285520530
Fax
Email	dubenrj@gmail.com

Source of Monetary or Material Support

All India institute of Ayurveda,Gautampuri,Sarita Vihar,New Delhi-110076

Primary Sponsor

Name	All india Institute of Ayurveda
Address	Department of Shalakya Tantra,Gautampuri,Sarita Vihar,New Delhi
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Manjusha Rajagopala	AIIA	OPD No-101,Department of Shalakya Tantra,All India Institute of AyurvedaGautampuri,Sarita Vihar,New Delhi-110076 South West DELHI	7600901848 bhatrajma2008@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

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Patients with sign and symptoms of shuskakshipaaka (dry eye syndrome),

Intervention / Comparator Agent

Type	Name	Details
Intervention	Rajnidaaru Eyedrop	2 drops in both eyes will be administered twice a day for 42 days.
Comparator Agent	Rajnidaaru eyedrop with Rasayan Churna	2 drops in both eyes will be administered twice a day for 42 days along with 3g Rasayan Churna twice a day for 42 day

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1.Patients of either sex aged up to18 - 60 years. 2.Patients presenting with signs and symptoms of Dry eye syndrome. 3.Willing and able to participate in the study.

ExclusionCriteria

Details

1.Age group less than 18 and more than 60 years.
2.Severe cases of dry eye syndrome with complications like perforated corneal ulcer, Uveitis, Glaucoma.
3.Allergic eye disease i.e. vernal keratoconjunctivitis, Giant papillary conjunctivitis.
4.Non specific topical beta blocker users.
5.Inflammatory conditions like acute conjunctivitis.
6.Patients on steroids, oral contraceptive pills, estrogen replacement therapy or any other medication such as antispasmodic drugs like Atropine that may adversely affect the outcome of the study.
7.Patients suffering from major systemic illness necessitating long term drug treatment i.e. Psycho-epileptic drug users.
8.H/o hypersensitivity to the trial drug or any of its ingredients.
9.Persistent Contact Lens Users.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Alternation

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Reduction in clinical features of dry eye syndrome	The patients will be assesed at the end of the study

Secondary Outcome

Outcome	TimePoints
Changes in the quality of life	The patients will be assesed at the end of the study

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 4

Date of First Enrollment (India)

15/04/2018

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="3"
Months="2"
Days="3"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

The outcomes of the study will be communicated to peer reviewed journals.

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

This study is an open label double arm randomised clinical trial comparing the efficacy of Rajnidaaru eye drops (2drop in each eye)along with Rasayan Churna(3g BD) and alone for 42 days in patients of shuskakshipaaka (Dry eye syndrome) for 30 days.The trail will be conducted in All India institute of Ayurveda.The primary outcome measures will be reduction in th clinical features of dry eye syndrome and the secondary outcomes will be changes in quality of life.