To Evaluate the Safety and Efficacy of Oral administration of Tep-AD�® (probiotic Lactobacillus salivarius) in Indian Children having by Moderate and Severe Atopic Dermatitis.
- Conditions
- Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
- Registration Number
- CTRI/2022/01/039781
- Lead Sponsor
- Inzpera Healthsciences Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Male or female children between 0-11 years of age (both inclusive)
Suffering from moderate or severe atopic dermatitis.
Children and parents / guardians who agree to comply with study requirement and schedule.
Parents or legal guardians willing to sign written informed consent form for the child and child
willing to sign assent form for participation (if old enough to understand his /her participation
in study)
1. Use of analgesics within <12 hours prior to the study start or/and inability to cancel them during
the study.
2. Use of antibiotics within <48 hours prior to the study start or/and inability to cancel them during
the study.
3. Subjects with any other chronic illness such as acute asthma, heart blocks, any congenital
anomaly.
4. Subjects with chronic and infectious diseases.
5. Subjects with hypersensitivity to any components contained in the probiotic sachets.
6. Inability to keep return appointments.
7. Participated in any clinical investigation in the last 30 days.
8. Not found suitable as per discretion of investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method