Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
None listed
Sponsors
SG Phyto Pharma Pvt Ltd
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged between 21 and 65 years -both ages and all genders inclusive-, diagnosed with Psoriasis vulgaris i. Psoriasis vulgaris: Plaque psoriasis ii. Type I and Type II iii. Moderate Severity: BSA 3%-10% 2. Subjects who are willing to abstain from use of any and medication or supplementation intended for the treatment or management of psoriasis not limited to oral, IV, IM, ID, topical therapy regimens. 3. Subject or LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period. 4. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to herbal investigational product or its constituents. 2. Subjects with any other dermatological conditions not limited to scarring of the body surface intended for clinical examination 3. Subjects with immunucompromised state complications. 4. Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he or she participates in the study. 5. Subjects with uncontrolled diabetes, hypertension or congestive heart failure. 6. Subjects with history of substance abuse or in sobriety for less than 3 years at the time of screening. 7. Subjects with history of cancer or in remission for less than 3 years at the time of screening. 8. Subjects who have had a major surgery less than 6 months at the time of screening. 9. Women who are pregnant, nursing or have had active pregnancy or miscarriage less than 1 year prior to the time of screening. 10. Any significant medical condition -e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc.-, any medical condition that is unstable or poorly controlled or other factor -e.g., planned relocation- that the Investigator felt would interfere with study evaluations and study participation. 11. Subjects who have participated in any clinical study within 3 months from the date of enrolment. 12. Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 13. Subjects, who in the opinion of the Investigator, are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PASI: Psoriasis Area and Severity Index: Reduction of â?¥50% from baseline DLQI: Dermatology Life Quality Index: Reduction of â?¥5 scores from baseline Safety Evaluation: Monitoring the occurrence, frequency, severity and causality of Adverse events. Timepoint: PASI: Psoriasis Area and Severity Index: Day 1, Day 30, Day 60 and Day 90 DLQI: Dermatology Life Quality Index: Day 1, Day 30, Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare R&D India Pvt. Ltd.
Outcome results
None listed