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Trial to determine the safety, efficacy and ease of use of Transdermal Application of Multi Nutrient Lotion

An Open Label, prospective, Randomized, Placebo Controlled, Three-Treatment, Parallel, Comparative Trial to determine the safety, efficacy and ease of use of Transdermal Application of Multi Nutrient lotion manufactured by Murlikrishna Pharma Pvt. Ltd., India with standard Supportive Care Treatment infemale patients with mild Anemia - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070555
Enrollment
300
Registered
2024-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D539- Nutritional anemia, unspecified

Interventions

Intervention1: Transdermal Liposomal Lotion: Product Description: Product containing API of Ferrous Bis Glycinate (Elemental Iron), Vitamin B12,Vitamin D3, Folic Acid Dosage and Administration: 5 ml -

Sponsors

Murali Krishna Pharma Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

India

Contacts

Public ContactDr Hema Divakar

Medical Director-Divakars Speciality Hospital

drhemadivakar@gmail.com9900154448

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026