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Clinical trial of some Ayurvedic drugs and special diets in the management of Psoriasis

Phase 2
Conditions
Health Condition 1: null- Psoriasis
Registration Number
CTRI/2015/01/005426
Lead Sponsor
Central Council for Research in Ayurvedic Sciences CCRAS
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

1. Patients of either sex with age between 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. V.D.R.L. / HIV/Hepatitis negative.

6. Positive histopathological finding.(Skin-biopsy)

7. Willing to participate in the study.

Exclusion Criteria

1. Generalized skin lesions, Herpes simplex, Herpes zoster, Scabies, Acne, Urticaria, Immunological medicated skin diseases like Pempigus vulgaris, Dermatitis ,herpetiformis, Guttate, Pustular, 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 (Blood sugar fasting more than 250 mg/dl).

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

6. Patientâ??s suffering/Past history of Heart disease, serious hepatic disorders, Severe Pulmonary Dysfunction, Renal Disorders etc.

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

8. Patients with concurrent serious hepatic disorder or renal disorders, AIDS, STD etc.

9. Alcoholics and/or drug abusers.

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

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

12. Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
â?¢ Changes in Psoriasis Severity score.Timepoint: Two Years
Secondary Outcome Measures
NameTimeMethod
â?¢ Changes in the clinical Sign & symptoms of Psoriasis. <br/ ><br>â?¢ Change in Dermatology life Quality Index (DLQI) Questionnaire. <br/ ><br> <br/ ><br>Timepoint: Two Years
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