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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 300 study participants - To evaluate the efficacy of transdermal application of Multi nutrient Lotion for prevention of micronutrient deficiencies in mildly anemic women
研究概览
简要总结
| STUDY TITLE: “A |
| Triple-Blind, 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 in female patients with mild |
| Anemiaâ€. |
| Protocol No. |
VRL-CT-23-020
|Version No.
1.0
|Date
22 Sep 2023
|Principal Investigator
Dr. Hema Divakar
Screening period
After obtaining the informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessment. The total duration of study will be of 12 weeks, which excludes 3 week (maximum) of screening period.
The study consists of following visits:
· Visit 1 (Day -21 to -1): Screening period
· Visit 2 (Day 1): Randomization visit
· Visit 3 (Day 28 ± 2 Day) (Week 4): Treatment visit
· Visit 4 (Day 56 ± 2 Day) (Week 8): Treatment visit
· Visit 5 (Day 84 ± 2 Day) (Week 12): End of Study visit
Eligible patients will be given either:
Arm A: Transdermal Liposomal Lotion of each 2.5 ml Contains Ferrous Bisglycinate (Elemental Iron 5 mg), Vitamin B12 (0.0004 mg), Vitamin D3 (0.01 mg) & Folic Acid (0.05 mg) 5ml single application once a day on the skin over the dorsum aspect of either forearm, preferably at same time daily for the entire study duration
Arm B: Ferrous bisGlycinate (Elemental Iron 30 mg), Zinc picolinate (Elemental Zinc 11 mg), Folic acid (0.5 mg) & Vitamin B12 (7.5 mcg) Tablets – one table orally once daily preferably at same time daily for the entire study duration
Arm C: Placebo Transdermal Liposomal Lotion
- 5ml single application once a day on the skin over the dorsum aspect of either forearm, preferably at same time daily for the entire study duration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects meeting following criteria will be included in the study:
- •Female patients with age 18-50 years (both inclusive), residing in the study area.
- •Iron deficiency anemia with low hemoglobin ranging from 9-10.9 g/dL at the onset of the study (at first visit).
- •Patient is willing to give informed consent, able to provide availability for the entire study period and follow study protocol.
排除标准
- •Women or girls with significant co-morbidities including hemoglobinopathies.
- •Patients who have received blood or blood products transfusion during the current illness
- •Patients with generalized skin disorder hampering the regular application transdermal of investigational drug
- •Pregnant and lactating women.
结局指标
主要结局
300 study participants - To evaluate the efficacy of transdermal application of Multi nutrient Lotion for prevention of micronutrient deficiencies in mildly anemic women
时间窗: (Day 84 ± 2 Day) (Week 12)
次要结局
- 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.(One year)
研究者
Dr Hema Divakar
Medical Director - Divakars Speciality Hospital