CTRI/2024/03/064308尚未招募2 期
Efficacy of Add- on Punarnava Mandura and Varuna-Shigru Kwatha in the Management of Anemia Associated with Non-Dialysis Dependent Chronic Kidney Disease (Kaphaja Pandu) – A Randomized Standard Controlled Clinical Trial - NI
Institute of Teaching and Research in Ayurveda0 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
- 2 期
- 状态
- 尚未招募
- 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.Patients willing to give written informed consent by themselves.
- •2.Patient having signs and symptoms of Kaphaja Pandu. [Gaurava (heaviness), Tandra (drowsiness), Chhardi (vomiting), Shwetavabhasta (paleness), Praseka (salivation), Sada (fatigue), Murchha (fainting), Bhrama (giddiness), Klama (mental fatigue), Shwasa (dyspnea), Kasa (cough), Alasya (laziness), Aruchi (anorexia), Shukla Mutra-Akshi-Varcha (whitish coloration of the eyes, urine, and feces), Shwayathu (edema) ]
- •3.Patients aged 18 to 70 yrs.
- •4.Patient having a diagnosis of chronic kidney disease (CKD), with Kidney Disease Outcomes Quality Initiative (KDOQI) stage 3, 4, or 5, not receiving dialysis; with an estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2.
- •5.The patient’s hemoglobin (Hb) values less than or equal to 10.5 g/dL.
- •6.Ferritin greater than or equal to 50 ng/mL at randomization (obtained from screening visit).
排除标准
- •1.Red blood cell transfusion within 8 weeks prior to randomization.
- •2. Patient with a known history of myelodysplastic syndrome or multiple myeloma, or any kind of malignancies.
- •3. Patient having a known hereditary haematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD.
- •4.A known case of haemosiderosis, hemochromatosis, coagulation disorder, or hypercoagulable condition.
- •5.Transferrin saturation (TSAT) gtreater than or equal to 15% at randomization (obtained from the screening visit).
- •6.Patient’s alanine aminotransferase and aspartate aminotransferase will be less than or equal to 3 x upper limit of normal (ULN), and total bilirubin will be less than or equal 1.5 x ULN.
- •7.A known case of chronic inflammatory disease that could impact erythropoiesis (eg, systemic lupus erythematosus, rheumatoid arthritis, celiac disease), even if it was in remission.
- •8.Patients anticipated undergoing elective surgery that was expected to lead to significant blood loss during the study period or anticipated elective coronary revascularization.
- •9.A known case of active or chronic gastrointestinal bleeding or any current condition leading to active significant blood loss.
- •10.Patient has a history of chronic liver disease (eg, cirrhosis or fibrosis of the liver).
- •11.Patient has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
- •12.Patient who has a diagnosis or suspicion (eg, complex kidney cyst of Bosniak Category 2F or higher) of renal cell carcinoma as shown on renal ultrasound within 12 weeks prior to randomization.
- •13.A known case of positive Human immunodeficiency virus/Hepatitis B surface antigen/anti-hepatitis C virus antibody.
- •14.Patient has an active clinically significant infection that is manifested by white blood count greater than ULN, and/or fever, in conjunction with clinical signs or symptoms of infection within 1 week prior to randomization.
- •15.Patient has a history of alcohol or drug abuse.
- •16.Systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 90 mmHg (confirmed by repeated measurement), within 2 weeks prior to randomization.
- •17.If the patient has known allergy to the investigation product or any of its ingredients.
- •18.Patient has any medical condition that, in the opinion of the investigator, may pose a safety risk to a patient in this study, which may confound efficacy or safety assessment, or may interfere with study participation.
- •19.Pregnant/breastfeeding female at screening or throughout the study period.
研究者
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