Role of selected Ayurvedic formulations in the management of psoriasis.

Phase 3

• Conditions: Health Condition 1: L409- Psoriasis, unspecified

• Registration Number: CTRI/2023/06/053619
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients of any gender, in the age group 18 and 60 years.

2.Known cases of psoriasis, without psoriatic arthropathy, exhibiting psoriatic triad â??

a.Bright pink or red lesions with pronounced edges, covered with silvery white scales, the scales can be easily separated from the lesion.

b.Under the scales there appears a pinkish moist tender skin.

c.With the scraping of the moist skin there appear tiny blood droplets (Auspitzâ??s sign)

3.Patients suffering from psoriasis with less than 50 % of the body surface involvement.

4.Disease duration between 3 months to 5 years.

5.Willing to give informed consent.

Exclusion Criteria

Patients with the following criteria will be excluded from the study:

1.Generalized skin lesions and a diagnosis for recent history of Herpes simplex, Herpes zoster, Scabies, Acne, Urticaria, and Immunological medicated skin diseases like Pemphigus vulgaris, Dermatitis,herpetiformis, Lupus erythematous, Psoriatic arthropathy etc.

2.Patients with poorly controlled Hypertension (Blood pressure more than 160/100mm of Hg).

3.Pregnant or lactating women.

4.Patient with uncontrolled Diabetes Mellitus (Hb A1C >8).

5.Patient who are known cases of autoimmune disorders.

6.Patient suffering from major systemic illness necessitating long-term drug treatment (Rheumatoid arthritis, cardiovascular disease Tuberculosis, Psycho - Neuro-endocrinal disorders, etc.).

7.Patients on medication with corticosteroids, phototherapy, biologics,antidepressants or any other drugs that may have an influence on the outcome of the study in the last 6 months.

8.Patients withHepatic Dysfunction (defined as AST and/or ALT >2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl)

9.Uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or AIDS or STD or other concurrent severe disease.

10.Alcoholics and/or drug abusers, & smoking.

11.H/o hypersensitivity to the trial drug or any of its ingredients.

12.Patients who have completed participation in any other clinical trial during the past six months.

13.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
1. Assessment of treatment adherence through self-reported compliance log and counting of used medication containers/strips. <br/ ><br>2. Assessment of the tolerability of the Ayurveda therapeutic regimen through reportedincidence of adverse events(GIT-related AE specifically) during the study period.Timepoint: 1. Day 1 to Day 180 <br/ ><br>2. Day 30, Day 60, Day 90, Day 120, Day 150, Day 180

Secondary Outcome Measures

Name	Time	Method
1. Change in the laboratory safety parameters from baseline (CBC, LFT, and KFT) <br/ ><br>2. Change in PASI score from baseline <br/ ><br>3. Change in Dermatology life Quality Index (DLQI) QuestionnaireTimepoint: 1. Day 0, Day 90, Day 180 <br/ ><br>2. Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 <br/ ><br>3. Day 30, Day 60, Day 90, Day 120, Day 150, Day 180