Beneficial Effect of Cow Colostrum on Platelet Count – A MulticenterGlobal Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- To check increasing trend of platelet count
研究概览
简要总结
Study Rationale:
Since the time immemorial, man has sought some alternative methods to enhance and improve the immune system of human body in order to fight against diseases. Historically, Ayurvedic physicians have used bovine colostrum for therapeutical application in Asia, particularly in India for thousands of years. Increased awareness of the diet - health relationship in many countries has stimulated a trend in nutrition science whereby more attention is given to the health effects of individual foods. (Seth, R., & Das, A. (2011). Colostrum is the initial milk secreted by bovine during parturition and the first few days after birth. Colostrum is a gift of nature used to protect the newborn’s immune system and provides passive immunity against pathogens. The presence of bioactive components such as insulin-like growth factor I and II (IGF-I and IGF-II), lactoferrin, lysozyme, lactoperoxidase, and immunoglobulin make the colostrum active against many pathogens. It is also active against Herpes simplex virus type-I (HSV-I), Human Immuno-deficiency virus-I (HIV-I), and human cytomegalovirus. Immunoglobulins are considered an important bioactive component in colostrum, and it contains high levels of immunoglobulin G (Ig G). Immuno-supplementation with bovine milk antibodies has been shown to provide local protection to the gastrointestinal tract against disease. (Tripathi, V., & Vashishtha, B. (2006).
The world-wide trend towards the development of health-promoting foods offers interesting opportunities for applications which contain specific antibody ingredients derived from immunized cows. It is anticipated that colostrum based preparations may have remarkable potential to contribute to human health care as part of health promoting diet and as an alternative or a supplement to the medical treatment of specified human diseases. Bovine colostrum virtually contain all compounds of human cellular and humoral immune defense. (Seth, R., & Das, A. (2011).
Thus, it has been observed that there is wide study on effect of bovine colostrum on gastro-intestinal diseases, HIV patients, athletes, also cancer patients but lack in study of effect of cow colostrum immunoglobulins on low platelet count induced by viral fever, cancer treatment.
All over the world milk and milk products of cow has been eating since Ancient time, it is easily available worldwide, easily digested with good absorption rate. Also colostrum has no side effect like any medicine as it is a food supplement, so there is a need of Study to check the Effect of Immunoglobulins present in Cow Colostrum in low platelet count subjects to increase the platelet count, enhance the immune system and for early recovery rate. In this study we are using cow colostrum which Lactose intolerance people also can eat it but we will exclude those patients. Also these supplements have been prepared by Freeze Dried method so there is no loss of Immunoglobulins.
Major components of cow colostrum:
The most important components of cow colostrum can basically be broken down into two major categories: Immune system factors and Growth factors.
Immunoglobulins (A, D, E, G and M) - the most abundant of the immune factors found in colostrum.
Lactoferrin - an antiviral, anti-bacterial, anti-inflammatory, iron- binding protein with therapeutic effects in many diseases.
Proline-Rich Polypeptide (PRP)
Growth Factors:
Epithelial growth factor (EgF)
Insulin-like growth factor-I and II (IGF-1 and IGF-II) Fibroblast growth factor (FgF)
Platelet-derived growth factor (PDGF) Transforming growth factors A & B (TgA and B) Growth hormone (GH)
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 10.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •To be eligible for the study, Subjects must meet the following criteria: 1.Male or female subjects of age group 10-18 years and 18-75 years 2.Confirmed clinical diagnosis of low platelet count by using complete blood count test (CBC).
排除标准
- •Subjects with any of the following conditions will be excluded from the study: 1.Subjects who is having Lactose Intolerance (Allergic to milk).
- •2.Those who are ‘Pure Vegan’ (Not taking any animal product including milk and milk products).
- •3.Acute or Chronic Kidney Disease 4.Pregnant females and Lactating mothers.
结局指标
主要结局
To check increasing trend of platelet count
时间窗: 3 months
次要结局
- Early recovery from the symptoms if any(3 months)
