Evaluation of herbal formulation in contact dermatitis

Phase 3

Completed

• Conditions: Unspecified contact dermatitis, unspecified cause. Ayurveda Condition: VICARCIKA,

• Registration Number: CTRI/2023/07/055420
• Lead Sponsor: Plant Ayu Life Sciences LLP Pune

Brief Summary

The present work was taken to assess the action of herbal formulations in patients suffering from Contact Dermatitis. The study population was 60 patients randomly divided into two equal groups of 30 individuals.

Group A – Subjects were advised to apply formulation( ECZ-cream-01) to cover lesions sufficiently ( cream formulations).

Group B – Subjects were advised to apply cream-based coconut oil(ECZ- cream 02) to cover lesions sufficiently.

The primary outcome of the study was to evaluate the changes in SCORing Atopic Dermatitis (SCORAD), the Secondary outcome of the study was to evaluate the changes in Dermatology Life Quality Index(DLQI) from baseline to 60 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-30
• Study Completion: 2024-04-29
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Age from 18.
• 60 yrs 2.Mild to moderate SCORing Atopic Dermatitis (SCORAD) > 5 % for > 1 months 3.Body surface involvement (BSI) of > 5% 4.Male or female 5.Willing to provide voluntary written informed consent.

Exclusion Criteria

• 1)Pregnant women and lactating mothers. 2)Patients suffering from systemic disorders as Cardiac, renal and hepatic diseases, Uncontrolled Diabetes mellitus, Uncontrolled Hypertension, Paralysis, Malignancy, Human immune deficiency virus infection, HBsAg, Leprosy. 3)Patients suffering from Psoriatic arthritis. 4)Patients who have received systemic therapy for psoriasis or those who have been treated with immunosuppressive immune.
• modulating treatment in previous 8 weeks. 5)Patient with personal or family history of malignant or premalignant skin tumours. 6)Subject with active infection either acute or chronic by fungi, viruses bacteria and parasites.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is to evaluate the changes in SCORing Atopic Dermatitis (SCORAD)	baseline to 60 days

Secondary Outcome Measures

Name	Time	Method
The Secondary outcome of the study is to evaluate the changes in Dermatology Life Quality Index(DLQI)	baseline to 60 days

Trial Locations

Locations (1)

National Institute Of Ayurveda; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute Of Ayurveda

🇮🇳Jaipur, RAJASTHAN, India

Dr Sarvesh Kumar Singh

Principal investigator

8739860237

sarveshksingh21@gmail.com