CTRI

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CTRI Number

CTRI/2020/09/027693 [Registered on: 10/09/2020] Trial Registered Prospectively

Last Modified On:

02/09/2020

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 Treatment for Allergic Conjunctivitis

Scientific Title of Study

Efficacy Of Nimbalodhra Kwatha Seka In The Management Of Vataja Abhishyanda W.S.R To Simple Allergic Conjunctivitis A Randomized Controlled 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 Prathibha Prakash
Designation	PG Scholar
Affiliation	KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya
Address	Dr Prathibha Prakash PG Scholar Department Of Shalakya Tantra KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya , Shahapur, Belgaum Belgaum KARNATAKA 590003 India
Phone	9742561473
Fax
Email	prathibha4prakash@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Meghana B Patil
Designation	Assistant Professor
Affiliation	KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya
Address	Department Of Shalakya Tantra KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya Shahapur Belgaum Belgaum KARNATAKA 590003 India
Phone	9742561473
Fax
Email	megs816@gmail.com

Details of Contact Person
Public Query

Name	Dr Meghana B Patil
Designation	Assistant Professor
Affiliation	KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya
Address	Department Of Shalakya Tantra KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya Shahapur Belgaum Belgaum KARNATAKA 590003 India
Phone	9742561473
Fax
Email	megs816@gmail.com

Source of Monetary or Material Support

KLE ACADEMY OF HIGHER EDUCATION AND RESEARCHES OWNED SHRI BM KANKANAWADI AYURVEDA MAHAVIDYALAYA AND KLE AYURVEDA HOSPITAL

Primary Sponsor

Name	Dr Prathibha Prakash
Address	Dr Prathibha Prakash PG Scholar Department Of Shalakya Tantra KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya shahapur Belgaum
Type of Sponsor	Other [Self Sponsored PG Dessertation]

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 Prathibha Prakash	OPD No 27	Department of Shalakya Tantra KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya and Hospital Belgaum KARNATAKA	9742561473 prathibha4prakash@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS SHRI BMK AYURVEDA MAHAVIDYALAYA & HOSPITAL SHAHAPUR BELAGAVI	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: H108\|\|Other conjunctivitis,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nimbalodhra kwatha	Nimba Lodhra kwatha seka will be done for 7 days
Comparator Agent	Triphaladi kwatha	Triphaladi kwatha seka will be done for 7 days

Inclusion Criteria

Age From	12.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Patients presenting with signs and symptoms of clinically established Vataja Abhishyanda and fulfilling the diagnostic criteria Patients with age group of 12 to 60yrs Patients of either sex

ExclusionCriteria

Details

Patients suffering from vernal Kerato conjunctivitis Atopic Kerato conjunctivitis Giant papillary conjunctivitis.
Patients having complicated eye diseases, Trachoma, Chalazion, Stye, Pterygium, Dacryocystitis, Trichiasis, etc.
Patients suffering from Corneal Opacity, Ulcers.
Diagnosed cases of Glaucoma and any ophthalmic infective conditions will be excluded.
Patients with other systemic disorders like renal diseases, uncontrolled hyperglycemia and hyperlipidemia, cardiovascular diseases etc will be excluded.
Extremely debilitated patients and in pregnancy.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Nimbalodhra kwatha seka is effective in the management of Vataja Abhishyanda w.s.r to Simple Allergic Conjunctivitis	18 months

Secondary Outcome

Outcome	TimePoints
Nimbalodhra kwatha seka is more effective than Triphaladi kwatha seka in the management of Vataja Abhishyanda w.s.r to Simple Allergic Conjunctivitis	18 months

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/ Phase 2

Date of First Enrollment (India)

01/11/2020

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="6"
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

TTThe study is to evaluate the efficacy of Nimbalodhra kwatha seka in the management of Vataja Abhishyanda w.s.r.t Allergic Conjunctivitis and to compare with Triphaladi kwatha seka when done for a period of 7 days. The study will be conducted at KAHERS Shri BM Kankanawadi Ayurveda Mahavidyalaya and Research Center owned KLE Ayurveda Hospital Shahapur Belgavi Karnataka India. The expected outcome is to reduce the signs and symptoms of Vataja Abhishyanda w s r to Allergic Conjunctivitis and to prove that nimbalodhra kwatha seka is more efficacous .