Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)
Conditions
Interventions
None listed
Sponsors
Institute of Teaching and Research in Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Correction of anemia (Mean change of Hb, and ferritin from baseline in 90 days) Timepoint: Group- A 90 Days Group- B 90 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Improvement of quality of life (with (KDQOL™-36)) (Mean change of score from baseline in 90 days) 2.Progression of CKD (Mean change of e-GFR from baseline in 90 days) 3.Hospitalization (number of participants who will need dialysis in 90 days) 4.Mortality (number of events in 90 days)Timepoint: Group- A 90 Days Group- B 90 Days | — |
Countries
India
Contacts
Public ContactDr Mandip Goyal
Institute of Teaching and Research in Ayurveda Jamnagar
Outcome results
None listed