Post marketing surveillance (PMS)study of Ascorbic acid (Vitamin C) and Zinc effervescent tablets
Phase 4
- Conditions
- Health Condition 1: 4- Measurement and Monitoring
- Registration Number
- CTRI/2023/02/049970
- Lead Sponsor
- Kusum Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Male and female with Age more than 18 year. 2)Vitamin C and zinc deficiency (based on independent clinical judgment of treating physician)3) Patients that requires treatment with Ascorbic acid and zinc tablets (as determined by treating physician) 4) Patients who provide informed consent
Exclusion Criteria
1) participation in another study 2) Presenting a risk of not being able to be followed. 3) Hypersensitivity to Ascorbic acid and zinc tablets
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Demographics data of patients require Ascorbic acid and zinc therapy.2. Well being through out duration of study 3. Risk benefit analysis based on active survillenceTimepoint: at baseline, 4th week, 8th week and 12 week (completion of treatment)
- Secondary Outcome Measures
Name Time Method To better understand the effectiveness and tolerability of therapyTimepoint: 12 weeks treatment