Clinical Assessment of antisickling herbomineral formulation T-AYU-HM Premium on sickle cell anemia at Dhanvantari clinic OPD patients: A prospective study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 2. Mean Change in the Level of Types of Hemoglobin in participants.
研究概览
简要总结
Sickle cell anemia a type of autosomal recessive disorder which requires treatment to be tolerated well throughout the life, safe and effective too. Preventing complications can be vital in preventing mortality in sickle cell patients. Sickling can be produced by a variety of factors, including hemolysis, cellular hyper-adhesion, oxidative stress, sterile inflammation, endothelial dysfunction, haemostatic activation, and blood hyper viscosity. During a sickling, these factors can cause sickle cell disease patients to become hypercoagulable. As a result, preventing this has become critical in the treatment of sickle cell patients. The formulation has documented anti-sickling activity. The previous studies have already suggested that T-AYU-HM Premium prevents lysis and there by sickling induced complications in sickle cell anemia. Therefore the primary objective of the study is to assess the effectiveness of T-AYU-HM Premium on red blood corpuscles and types of hemoglobin. The sickling induced activation of neutrophils and platelets during hypercoagulation state are might be the reason for causing vasoocclusive pain full crisis in sickle cell patients. Therefore, effectiveness of formulations preventing lysis and sickling can be reflected through the observation of other blood cell parameters in sickle cell anemia patients. Improvement in clinical parameters can be observed physically and through laboratory parameters to confer the effectiveness of formulation in sickle cell anemia patients. Acute pain in patients with sickle cell disease is caused by ischemic tissue injury resulting from the occlusion of microvascular beds by sickle erythrocytes during an acute crisis. Therefore the study emphasizes to evaluate changes in major and minor complains and impact of the treatment on pain and health related quality of life in patients receiving treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 7.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients between the ages above 07 to 55 years from both sexes from sickle hemoglobin.
- •2.Written informed parental/guardian consent and participant assent (where applicable) has been obtained per requirements, consistent with ICH guidelines.
- •3.Participant/Guardians must agree to adhere to Treatment guidelines.
- •4.Willingness to sign an informed written consent and comply with visit schedules.
- •5.Participants confirms of HBSS through HPLC
- •Participant who are confirmed Sickle cell anemia patients with positive microscopic sickle cell test, sickle cell solubility test.
- •7.Participants exhibit no other existing comorbidities 8.Participants having Negative Hepatitis B test.
- •Participants having veg/non veg diet 12.Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment 13.Participant needs to be admitted to the ambulatory site for treatment of VOC requiring pain medication.
排除标准
- •1.Participants not willing to participate 2.Participants having renal impairment 3.Participants not willing to visit clinic for schedule follow up.
- •4.Any other condition which the Principle Investigator thinks may jeopardize the study 5.Pregnant / lactating woman 6.Participants with unresolved infections or existing comorbidities.
- •7.Participants on any other treatment within 07 days of the first dose of study drug or who have not recovered from the side effects of such therapy 8.Participants have history of hospitalized treatment or blood transfusion before 15 days.
- •9.Participants taking any other then investigational drug in last 7 days 10.Participants who are allergic/Hypersensitivity reactions to herbal supplements and medications.
- •11.Participants who are unable to take and absorb oral medications, unable to swallow tablets.
- •12.Participants who are not able to understand and to comply with study instructions and requirements.
结局指标
主要结局
2. Mean Change in the Level of Types of Hemoglobin in participants.
时间窗: 1.Mean Change in Level of Red blood corpuscles in participants Measured by Laboratory analysis day 0, 15th, 120, and 180 day of schedule visit examination | 2. Mean Change in the Level of Types of Hemoglobin in participants Measured by HPLC for HbS,HbF, and HbA on 0 day, and 180 day of schedule visit examination. | 3.Mean Change in various blood counts in participants measured by Complete blood counts analysis day 0, 15th, 120, and 180 day of schedule visit examination
1.Mean Change in Level of Red blood corpuscles in participants.
时间窗: 1.Mean Change in Level of Red blood corpuscles in participants Measured by Laboratory analysis day 0, 15th, 120, and 180 day of schedule visit examination | 2. Mean Change in the Level of Types of Hemoglobin in participants Measured by HPLC for HbS,HbF, and HbA on 0 day, and 180 day of schedule visit examination. | 3.Mean Change in various blood counts in participants measured by Complete blood counts analysis day 0, 15th, 120, and 180 day of schedule visit examination
3.Mean Change in various blood counts in participants.
时间窗: 1.Mean Change in Level of Red blood corpuscles in participants Measured by Laboratory analysis day 0, 15th, 120, and 180 day of schedule visit examination | 2. Mean Change in the Level of Types of Hemoglobin in participants Measured by HPLC for HbS,HbF, and HbA on 0 day, and 180 day of schedule visit examination. | 3.Mean Change in various blood counts in participants measured by Complete blood counts analysis day 0, 15th, 120, and 180 day of schedule visit examination
次要结局
- 1.Mean change in major and minor complaints in participants(2. Extent of reduction in pain score during ambulatory visit as assessed by the participant on a pain scale)