CTRI

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CTRI Number

CTRI/2025/02/080869 [Registered on: 19/02/2025] Trial Registered Prospectively

Last Modified On:

19/02/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug
Siddha
Preventive

Study Design

Single Arm Study

Public Title of Study

A study on iluppai ennai in the management of kaduvan

Scientific Title of Study

A pilot study on clinical evaluation of siddha herbal formulation Iluppai Ennai( External Medicine) in the management of Kaduvan(Lichen Planus) among out-patients attending the OPD of ayodhidass pandithar hospital, National Institute of siddha.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Suruthi Balakrishnan
Designation	PG Scholar
Affiliation	National Institute of Siddha
Address	Room no 26/27 Department of nanju maruthuvam National institute of siddha Tambaram sanatorium Chennai Chennai TAMIL NADU 600047 India
Phone	07904646277
Fax
Email	suruthiks19@gmail.com

Details of Contact Person
Scientific Query

Name	Dr V Manjari
Designation	Associate professor
Affiliation	National Institute of Siddha
Address	Room no 26/27 Department of nanju maruthuvam National institute of siddha Tambaram sanatorium Chennai Chennai TAMIL NADU 600047 India
Phone	8056903083
Fax	044-22381314
Email	drmanjarimd@gmail.com

Details of Contact Person
Public Query

Name	Suruthi Balakrishnan
Designation	PG Scholar
Affiliation	National Institute of Siddha
Address	Room no 26/27 Department of nanju maruthuvam National institute of siddha Chennai Chennai TAMIL NADU 600047 India
Phone	07904646277
Fax	044-22381314
Email	suruthiks19@gmail.com

Source of Monetary or Material Support

National institute of siddha tambaram sanatorium Chennai 47

Primary Sponsor

Name	National Institute of siddha
Address	Room no 26/27 Department of Nanju Maruthuvam National Institute of siddha Tambaram sanatorium Chennai 47
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 B Suruthi	Ayothidass pandithar Hospital	Room no 26/27 Department of nanju maruthuvam National institute of siddha tambaram sanatorium Chennai 47 Chennai TAMIL NADU	07904646277 044-22381314 suruthiks19@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
National Institute of siddha	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: L439\|\|Lichen planus, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Iluppai ennai	External application of the medicine 30 ml for 1 week 2 times a day
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	30.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Age: 30 to 60 years Gender: Male/Female/Transgender Patients having the signs and symptoms of kaduvan (lichen planus) and LPSI score below 53 Purple polygonal planar pruritic papules plaques. Patients willing and able to provide informed consent and to comply with the study protocol.

ExclusionCriteria

Details

Pregnant or lactating women.
Known cases of Skin diseases [contact dermatitis, vitiligo, psoriasis, atopic dermatitis].
Other diseases or medications that might directly interfere in the study.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Reduction in LICHEN PLANUS SEVERITY INDEX Score will be assessed before and after treatment period.	2 months - Screening 2 months - Patient enrollment 2 months - outcome assessment

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="20"
Sample Size from India="20"
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 3

Date of First Enrollment (India)

03/03/2025

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="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary

Background:

Lichen planus (LP) is an inflammatory disorder of the skin and mucous membranes with no known cause. It appears as pruritic, violaceous papules and plaques most commonly found on the wrists, lower back, and ankles. A lattice-like network of white lines called Wickham striae overlies the lesions but is most easily observed on the buccal mucosa where erosions can also be present. It can display a variety of lesion types, but the most common presentation is an area of polygon-shaped, itchy, violaceous, flat-topped papules a few millimeters wide. This classic presentation is known as The Six Ps of LP: purple, polygonal, planar, pruritic papules, and plaques.

OBJECTIVE:

• To evaluate the therapeutic effectiveness of the external medicine “ILUPPAI ENNAI” in the management of KADUVAN (LICHEN PLANUS) through LPSI SCORE(3).

• LPSI score is expected to change from moderate to mild or nil and mild to nil after treatment

STUDY DESIGN : An open clinical trial – Single arm.

EXPECTED OUTCOME:

Changes in LICHEN PLANUS SEVERITY INDEX will be assessed before and after treatment.