Tolerability, treatment adherence, and safety of Drakshavaleha in the management of Iron Deficiency Anemia: An open label single arm clinical study - NI

Central Council for Research in Ayurvedic Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•Iron deficiency due to blood loss from the intestine or other sites.
•Other causes of anemia, apart from iron deficiency, apparent by history, physical
•examination, and/or laboratory tests.
•Iron deficiency anemia necessitating parenteral iron therapy
•Diabetic participants having FBS value 126 mg/dL or above
•Intake of Iron supplements for three months before the initiation of the study.
•Participants with Hepatic Dysfunction (defined as AST and/or ALT > 2 times of
•the upper normal limit)
•Participants with Renal Dysfunction (defined as S. creatinine >1.2 mg/dl);
•History of uncontrolled bronchial asthma, cardiovascular disease, cerebrovascular
•disease, psychiatric illness, tuberculosis, HIV, malignancy, etc.
•Patients suffering from major systemic illnesses necessitating long-term treatment
•(Psycho-neuro-endocrinal disorders, etc.)
•Hormone therapy (including the use of androgens/anabolic steroids) or administration
•of drugs that affect erythropoiesis, less than three months before the start of the study.
•Female participants who are pregnant, intend to become pregnant, are breastfeeding,
•or not willing to use effective contraceptive precautions during the study.
•History or active substance abuse
•History of hypersensitivity to the trial interventions or their ingredients.
•Any other condition that in the opinion of the investigator may compromise the
•participant’s safety or compliance

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