Study to evaluate the efficacy of Ayurvedic Intervention with Yoga and Placebo as a treatment regime for Iron Deficiency Anemia: an open label, three arm, randomised control trial.

Patanjali Research Institute governed by Patanjali Research Foundation Trust0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•1. Adult male and non-pregnant female population having mild or moderate Iron Deficiency anemia (IDA) caused by different aetiology such as abnormal uterine bleeding and other conditions leading to significant blood loss prior to trial enrolment.
•2. Hemoglobin ranges
•Non pregnant women mild: 110 to 119 g per l, moderate: 80 to 109 g per l.
•Men, 15 years and above mild: 110 to 129 g per l, moderate: 80 to 109g per l.
•3. Transferrin saturation less than 20%
•4. S-ferritin less than 30 Âµg per l.
•5. Willingness to participate and sign the informed consent form.

•1.Anemia predominantly caused by factors other than Iron Deficiency Anemia e.g. anemia with untreated vitamin B12 or folate deficiency, sickle cell anemia, thalassemia minor.
•2. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
•3. Pregnant or lactating women.
•4. Known hypersensitivity to any excipients in the investigational drug products.
•5. Erythropoietin treatment within 8 weeks prior to the screening visit.
•6. Patients planning surgery within the trial phase or received a blood transfusion a week prior to the screening visit.
•7. Any other medical condition that, in the opinion of investigator, make the patient incompetent to participate in the trial or place the patient at potential risk, e.g. any chronic comorbidity.

发起方

Patanjali Research Institute governed by Patanjali Research Foundation Trust