EFFECT OF KHADIRARISHTA, KAISHORE GUGGULU AND GANDHAKADI MALHAR IN THE VICHARCHIKA (ECZEMA)

Phase 2

Completed

• Conditions: Health Condition 1: L209- Atopic dermatitis, unspecified

• Registration Number: CTRI/2020/11/029384
• Lead Sponsor: Central Council for Research in Ayurvedic sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-09-20
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Known cases of eczema (based on Hanifin and Rajka Criteria for Atopic Dermatitis/ Atopic Eczema) and willing and able to participate in the study

Exclusion Criteria

Patients with Status Eczematous condition.

Patients with poorly controlled Hypertension ( >160/100 mmHg)

Patients with uncontrolled Diabetes Mellitus having HbA1C > 8%

Patients on medication with corticosteroids, phototherapy, biologics, antidepressants and any other drugs that may have an influence on the outcome of the study.

Patients who have history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months

Symptomatic patients with clinical evidence of Heart failure

Known cases of HIV and AIDS.

Known cases of malignancy

Patient taking participation in any other clinical trial.

Women who are planning for conception / pregnant or lactating.

Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD)

H/o hypersensitivity to any of the trial drugs or their ingredients

Patients who have completed participation in any other clinical trial during the past three months

Any other condition which the Investigator thinks may jeopardize the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the clinical efficacy of Khadirarishta, Kaishoreguggulu and Gandhakadimalaharin Vicharchika (Eczema) by the assessmentof Change in Eczema Area Severity Index score (EASI)Timepoint: 14th day 28th day 42th day 56th day 70th day 84th day

Secondary Outcome Measures

Name	Time	Method
Changes in clinical Sign & symptoms as per the Ayurvedic classics <br/ ><br>Changes in Patient Oriented Eczema measure (POEM)Changes in Dermatology Life Quality Index (DLQI) Questionnaire <br/ ><br>Timepoint: 14th day 28th day 42th day 56th day 70th day 84th day