CTRI/2023/05/053299招募中3 期
Tolerability, treatment adherence and safety of an Ayurvedic intervention-PunarnavadiMandura in the management of Iron Deficiency Anemia: An open label single arm clinicalstudy
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES Ministry of AYUSH0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Subjects of any gender aged 18-60 years and diagnosed with IDA
- •2.Mean corpuscular volume (MCV) below 80 fl.
- •3.Hemoglobin 8-10.9 gm/dl (as per WHO)
- •4.Willing to provide written informed consent
排除标准
- •1.Iron deficiency due to blood loss from the intestine or other sites.
- •2.Other causes of anemia, apart from iron deficiency, apparent by history, physical examination, and/or laboratory tests.
- •3.Iron deficiency anemia necessitating parenteral iron therapy
- •4.Intake of Iron supplements for three months before the initiation of the study.
- •5.Participants with Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit)
- •6.Participants with Renal Dysfunction (defined as S. creatinine >1.2 mg/dl);
- •7.History of uncontrolled bronchial asthma, cardiovascular disease, cerebrovascular disease, psychiatric illness, tuberculosis, HIV, malignancy, etc.
- •8.Patients suffering from major systemic illnesses necessitating long-term treatment (Psycho-neuro-endocrinal disorders, etc.)
- •9.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.
- •10.Female participants who are pregnant, intend to become pregnant, are breastfeeding, or not willing to use effective contraceptive precautions during the study.
- •11.History or active substance abuse
- •12.History of hypersensitivity to the trial interventions or their ingredients.
- •13.Any other condition that in the opinion of the investigator may compromise the participant’s safety or compliance
研究者
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