Health Condition 1: L309- Dermatitis, unspecified
Conditions
Interventions
Intervention1: Sengathaari Ennai: Dose: 10 ml twice a day with warm water.
Course: For 7 Weeks
Course may be repeated after 1 week of drug holiday if recovery is
not complete. The course will not be repeated if no resolution is observed
Test drug will be given till the defined recovery or 15 w
Sponsors
A LAZHA
Eligibility
Inclusion criteria
Inclusion criteria: Signed and dated written informed consent following Good Clinical Practice (GCP) and local legislation before the start of any screening procedures Diagnosis of eczema for at least 6 months Women of child bearing potential (WOCBP) must be ready and able to use highly effective methods of birth control
Exclusion criteria
Exclusion criteria: Use of topical corticosteroids or other agents for eczema within 7 days before the first dose of trial treatment. Use of systemic corticosteroids or other agents for dermatitis within 4 weeks before the first dose of trial treatment. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating; they should refrain from breastfeeding up to 16 weeks after the last study drug administration Organ transplants and patients with renal replacement therapy. Any documented active or suspected malignancy or history of malignancy within 5 years before the screening visit, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of the uterine cervix. Use of any restricted medication or any drug considered likely to interfere with the safe conduct of the study. Active systemic infections (Fungal and bacterial disease) during the last 2 weeks prior to the first drug administration. Relevant chronic or acute infections (exception: common cold) including human immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the patient was treated and is cured of the acute infection. Active or Latent Tuberculosis Currently enrolled in another investigational device or drug trial, or less than 30 days or 5 half- lives, whichever is longer since ending another investigational device or drug trial(s), or receiving other investigational treatment(s). Evidence of current or previous disease, medical condition (including chronic alcohol or drug abuse or any condition) other than AD, surgical procedure, psychiatric or social problems, medical examination finding (including vital signs and ECG), or laboratory value at the screening outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol, comply with all study visits/procedures or to complete the trial, compromise the safety of the patient or compromise the quality of the data. Major surgery (major according to the investigator) performed within 12 weeks before the first study drug administration or planned during the study Severe, progressive, or uncontrolled hepatic disease, is defined as greater than 3-fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or greater than 2-fold ULN elevation in total bilirubin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in the Eczema Area and Severity Index (EASI) and SCORAD scores at baseline and endpoint [Time Frame: Baseline (day 1) and 7 weeks and/or if course repeated at 15th week or when the lesions are fully resolved whichever is earlier].Timepoint: Percentage change in the Eczema Area and Severity Index (EASI) and SCORAD scores at baseline and endpoint [Time Frame: Baseline (day 1) and 7 weeks and/or if course repeated at 15th week or when the lesions are fully resolved whichever is earlier]. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with a 50% improvement from baseline in Eczema Area and Severity Index (EASI) (EASI50) at Week 7 and 15Timepoint: Baseline (Day 1) and Week 15 ;The proportion of patients with a 75% improvement from baseline in Eczema Area and Severity Index (EASI) (EASI75) at Week 7 and 15Timepoint: Baseline (Day 1) and Week 15;Number of participants with trial drug-related Adverse Events (AEs)Timepoint: Baseline (Day 1) and Week 15;Change from baseline in SCORing of Atopic Dermatitis (SCORAD)Timepoint: weeks7 and 16;The difference in the proportion of patients who have atypical Neikkuri findings (i.e sieve pattern) in baseline converted to typical Neikkuri patterns (i.e. coin-shaped pattern) with treatment and recovery. The duration taken for conversion from atypical to typical patterns in the converted will be compared between the two groupsTimepoint: At baseline and after resolution of lesions;Estimation of body temperature, and heart rate variability during and after the intervention.Timepoint: NIL;Variations of Dermatitis biomarkers indicating the eczema related inflammation like IL 13, CD 25 cells, EG2 + cells through lesional skin Immuno histochemistry and Serum CCL 17 / TARC levels through ELISA will be assessedTimepoint: At baseline(day 1) and at endpoint(Week 15);The difference in Point prevalence of Mood symptoms will be compared using the Hospital Anxiety and Depression Scale (HADS)Timepoint: At baseline (Day 1), 7th week and 15th week;Preclinical safety data with the administration of test drug to rats will be generated Timepoint: NIL;Preclinical data of anti eczematous potential of the test drug will be generated both in vivo and in vitro.Timepoint: NIL;Thegi characterization with propensity to increased therapeutic response to test drug will be identified.Timepoint: NIL | — |
Countries
India
Contacts
Public ContactGJ Christian
National Institute of Siddha
Outcome results
None listed