Health Condition 1: L409- Psoriasis, unspecified
Conditions
Interventions
Intervention1: Ayurvedic formulations: •PancaTiktakam Gritha 6 gm twice daily oral administration, before food with luke warm water for 180 days
Nalpamaradi taila 25 ml external application twice da
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of any gender, in the age group 18 and 70 years. 2. Known cases of psoriasis, without psoriatic arthropathy, exhibiting psoriatic triad – 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 (Auspitz’s sign) 3. Patients suffering from psoriasis with less than 50 % of the body surface involvement. 4. Disease duration between 3 months to 8 years. 5. Willing to give informed consent.
Exclusion criteria
Exclusion criteria: 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 arthropathyetc. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Primary •Assessment of treatment adherence through self-reported compliance log and counting of used medication containers/strips. [Time frame: Day 1 to Day 180] •Assessment of the tolerability of the Ayurveda therapeutic regimen through reportedincidence of adverse events(GIT-related AE specifically) during the study period.[Time frame: day 30, 60, 90, 120, 150, 180] Secondary •Change in the laboratory safety parameters from baseline (CBC, LFT, and KFT).[Time frame: baseline, day 60, 180] •Change in PASI score from baseline[Time frame: day 30, 60, 90, 120, 150, 180] •Change in Dermatology life Quality Index (DLQI) Questionnaire[Time frame: day 30, 60, 90, 120, 150, 180] Timepoint: day 30, 60, 90, 120, 150, 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary • Change in the laboratory safety parameters from baseline (CBC, LFT, and KFT).[Time frame: baseline, day 60, 180] • Change in PASI score from baseline[Time frame: day 30, 60, 90, 120, 150, 180] • Change in Dermatology life Quality Index (DLQI) Questionnaire[Time frame: day 30, 60, 90, 120, 150, 180]Timepoint: Time frame: day 30, 60, 90, 120, 150, 180] | — |
Countries
India
Contacts
Public ContactDr Emy S Surendran
Regional Ayurveda Research Institute-Thiruvananthapuram
Outcome results
None listed