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A study to evaluate two drugs, Panchatikta Ghrita and Nalpamaradi Taila in patients with Vicharchika(Eczema)

Phase 2
Completed
Conditions
Health Condition 1: L309- Dermatitis, unspecified
Registration Number
CTRI/2019/12/022236
Lead Sponsor
Central Council for Research in Ayurvedic Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

1.Patients of either sex with age between 18 and 60 years

2.Known cases of eczema (based on Hanifin and Rajka Criteria

for Atopic Dermatitis/ Atopic Eczema).

3.Patients willing and able to participate in the study

Exclusion Criteria

1.Patient with Status Eczematous condition.

2.Patient with poorly controlled Hypertension ( >160/100 mmHg)

3.Patient with uncontrolled Diabetes Mellitus having HbA1C > 8%

4.Patient on medication with corticosteroids, phototherapy,

biologics, antidepressants and any other drugs that may

have an influence on the outcome of the study.

5.Alcoholic and/or drug abuser

6.Symptomatic patients with clinical evidence of heart failure.

7.Known case of HIV and AIDS.

8.Known case of Malignacy.

9.Patienttaking participation in any other clinical trial.

10.Woman who are planning for conception/pregnant or lactating.

11.Patientwith concurrent serious hepatic disorders (defined as aspartate amino (AST) and/ or Alanine AminoTransferase(ALT) >2times 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).

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

13.Patient who have completed participation in any other

clinical trial during the past three months.

14.Any other condition which the Investigator thinks may

jeopardize the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in Eczema Area Severity Index score (EASI) <br/ ><br>Change in Patient Oriented Eczema measure (POEM) <br/ ><br>Change in Dermatology life Quality Index (DLQI ) Questionnaire score <br/ ><br>Timepoint: At Baseline, 14th day, 28th day, 42th day, 56th day, 70th day, 84th day and 112th day
Secondary Outcome Measures
NameTimeMethod
Change in Signs & Symptoms.Timepoint: At Baseline, 14th day, 28th day, 42th day, 56th day, 70th day, 84th day and 112th day
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