Trial to determine the safety, efficacy and ease of use of Transdermal Application of Multi Nutrient Lotio
Not Applicable
- Conditions
- Health Condition 1: D539- Nutritional anemia, unspecified
- Registration Number
- CTRI/2024/07/070555
- Lead Sponsor
- Murali Krishna Pharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Subjects meeting following criteria will be included in the study:
1. Female patients with age 18-50 years (both inclusive), residing in the study area.
2. Iron deficiency anemia with low hemoglobin ranging from 9-10.9 g/dL at the onset of the study (at first visit).
3. Patient is willing to give informed consent, able to provide availability for the entire study period and follow study protocol
Exclusion Criteria
1.Women or girls with significant co-morbidities including hemoglobinopathies.
2.Patients who have received blood or blood products transfusion during the current illness
3.Patients with generalized skin disorder hampering the regular application transdermal of investigational drug
4.Pregnant and lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 300 study participants - To evaluate the efficacy of transdermal application of Multi nutrient Lotion for prevention of micronutrient deficiencies in mildly anemic womenTimepoint: (Day 84 ± 2 Day) (Week 12)
- Secondary Outcome Measures
Name Time Method To evaluate the safety & tolerability of transdermal application of Multi nutrient Lotion for prevention of micronutrient deficiencies in mildly anemic women. Time points One year.Timepoint: One year