A Prospective, Randomized, Open Label Study to Evaluate the Safety And Efficacy Of Mulmina Orange Amla Ready to Drink as a Supplement In Women With PCOS
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Overall improvement in the PCOD condition from baseline
研究概览
简要总结
A Herbal Immune Boosting and Anti-oxidantdrinks for wellness with particular emphasis as a health promoter. Theformulation is meant for general health and well-being with the herbs concernedacting synergistically to provide an immune boosting properties and highanti-oxidant benefit without any attenuating side-effects. Cardinal to theinvention is the synergistic play between the natural ingredients andMeso-nutrients which provide an Immune Boosting Activity and rich Anti-oxidantthrough its higher ORAC values.
Wellness drink MulminaAmla Orange whereinthe herbs, fruit extract and fortifying agents act synergistically to provide arich Meso-nutrients contributing Antioxidant and Immune Boosting Propertythrough its high ORAC values. The said beverage is formulated with a carefully chosenherbs–that are meant to act as anti-inflammatory, immune-boosting andfree-radical scavenging agents. The herbs so formulated is combined with ahealthy vitamin and mineral rich, anti-oxidant fruit juices and is fortifiedwith the necessary vitamins and minerals to result in a very tasty drink forgood health. The taste factor makes the herbal concoction palatable and henceensure compliance. Hence this preparation has all the three categories ofnutrients namely Macro-nutrients (Carbohydrates, Protein, Dietary Fibres etc),Micro Nutrients (Vitamins and Minerals), which are required for the body toperform wellness. Another uniqueness of the formulation i.e. Tetrapaktechnology, This is known all over world for its aseptic technology, Product ispacked in Cylindrical Tetra Brick pack which will not come in contact with anyexternal environmental conditions. Filled in automatic machines with form –Fill - Seal concept in aseptic conditions known to preserve its productproperties and ensures longer shelf life of 12months
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •i.Female volunteer aged more than 18 years ii.Women with mild PCOS related complications iii.Willing to give written consent to participate.
排除标准
- •1.Patients with preexisting severe systemic disease necessitating long term medication.
- •2.Patients with known history of diabetes mellitus.
- •3.Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation.
- •4.History of cancer including solid tumors hematologic malignancies and carcinoma in situ 5.Any neurological congenital or acquired vascular or systemic disorder which could affect any of the efficacy assessments.
- •6.Participation in the current or previous treatment with any approved or investigational health supplements during the past 1 month.
结局指标
主要结局
Overall improvement in the PCOD condition from baseline
时间窗: Day 0, 14 and 28
次要结局
- General health and adverse events(Day 0 to Day 28)