A Study to See if Paradi Marham Is Safe and Improves Skin Symptoms in People with Mild to Moderate Eczema

An Open-Label, Single-Arm, Single-Centre Clinical Study To Evaluate The Safety And Efficacy Of Paradi Marham In Participants With Mild To Moderate Eczema - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/105082

Enrollment

Registered

2026-02-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L309- Dermatitis, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: -Participants aged 18 to 65 years at the time of enrolment. -Participants with mild to moderate Eczema and with or without secondary bacterial infection. -Participants who are willing to avoid other topical treatments during the study period. -Participants who are willing and able to provide written informed consent. -Participants who are willing to comply with the study requirements, including completing all scheduled visits and questionnaires.

Exclusion criteria

Exclusion criteria: -Subjects with severe or extensive eczema or any skin related conditions requiring systemic therapy. -Pregnant and lactating mothers. -Participants with usage of oral corticosteroids or immunosuppressant s within the past 30 days. -Participants with active skin conditions (e.g., psoriasis, lupus). -Chronic or uncontrolled systemic illness that may interfere with study participation (e.g., autoimmune disease, uncontrolled diabetes). -Participants with known allergy or intolerance to ingredients in the investigational product. -Participated in another clinical drug trial within 3 months before recruitment. -Any other condition which, in the opinion of the investigator, makes the participant unsuitable for enrolment. -Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to Baseline.

Design outcomes

Primary

Measure	Time frame
Change in Eczema Severity: Change in total Eczema Area and Severity Index (EASI) score from Baseline to End of Treatment (Day 20). Assesses improvement in key eczema domains including erythema, edema/papulation, excoriation, and lichenification across the defined body regions. Timepoint: Screening & Baseline (Day 0) Follow-up (Day 10 2 days) End of Study (Day 20 2 days)	—

Secondary

Measure	Time frame
1.Change in Quality of Life -Change in Dermatology Life Quality Index DLQI score from Baseline to Day 20 -Measures participant reported impact of eczema on daily activities symptoms emotional well being and social functioning. 2 Symptom Relief and Clinical Progression -Change in Investigator Global Assessment IGA score from Baseline to Day 10 and Day 20 -Evaluates clinician assessed overall improvement in eczema severity clear to severe scale -Time to onset of symptom relief itching erythema scaling as documented through IGA and participant diary review. 3 Safety and Tolerability -Incidence type severity and causality of Adverse Events AEs throughout the study -Any serious adverse events SAEs reported throughout the study period -Incidence and grading of local skin reactions including redness burning stinging irritation dryness or dermatitis -Investigators safety tolerability assessment at each study visitTimepoint: Screening & Baseline (Day 0) Follow-up (Day 10 2 days) End of Study (Day 20 2 days)	—

Measure

Time frame

1.Change in Quality of Life -Change in Dermatology Life Quality Index DLQI score from Baseline to Day 20 -Measures participant reported impact of eczema on daily activities symptoms emotional well being and social functioning. 2 Symptom Relief and Clinical Progression -Change in Investigator Global Assessment IGA score from Baseline to Day 10 and Day 20 -Evaluates clinician assessed overall improvement in eczema severity clear to severe scale -Time to onset of symptom relief itching erythema scaling as documented through IGA and participant diary review. 3 Safety and Tolerability -Incidence type severity and causality of Adverse Events AEs throughout the study -Any serious adverse events SAEs reported throughout the study period -Incidence and grading of local skin reactions including redness burning stinging irritation dryness or dermatitis -Investigators safety tolerability assessment at each study visitTimepoint: Screening & Baseline (Day 0) Follow-up (Day 10 2 days) End of Study (Day 20 2 days)

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Countries

India

Contacts

Public ContactMs Mamatha B Gokavi

Samahitha Research Solutions

satyalm@samahitha.com09739001749

Outcome results