CTRI/2019/03/018137
Completed
Phase 4
A prospective open label clinical study to evaluate the effectiveness of a herbal soap for skin - CSEETSBSH
Ramaiah Indic Specialty Ayurveda Restoration Hospital0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ramaiah Indic Specialty Ayurveda Restoration Hospital
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and female volunteers, with age 18â??45 years
- •2\.Subjects willing and able to provide informed consent voluntarily
- •3\.Subjects with facial acne grade of I\-III as assessed by Investigatorâ??s Global Assessment
- •4\.Willing to maintain the investigational product use throughout the study.
- •5\.Subjects who have not undergone any skin therapy in last 3 months
- •6\.Subjects with no known allergy to any of the test ingredients
- •7\.Women using oral contraceptives must have been doing so for at least 6 consecutive months prior to entering the study, and are required to continue with the same brand throughout the study period
- •8\.Subjects who are willing to refrain from using any skin care product other than the investigational product, like, moisturizers, face washes and face creams, for the duration of the study
- •9\.Subjects willing and able to comply with all trial requirements
- •10\.Laboratory workup within normal limits; including complete hemogram, glucose, blood urea nitrogen, creatinine, liver function test, lipid profile, thyroid\-stimulating hormone, urine pregnancy test
Exclusion Criteria
- •1\.Subjects who have skin diseases like psoriasis, atopic dermatitis , severe dry, self\-approved acne etc. at the time of screening
- •2\.Subject with chronic systemic illnesses or treatment that can affect skin health eg. dialysis
- •3\.Subjects on oral medications or suffering from chronic illness which will compromise the study
- •4\.Subjects who have participated in a similar investigation in the past four weeks
- •5\.Pregnant or lactating women
Outcomes
Primary Outcomes
Not specified
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