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
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 1.Correction of anemia (Mean change of Hb, and ferritin from baseline in 90 days)
Study Overview
Brief Summary
Anemia is a common complication in CKD. It leads to a reduced quality of life, worse renal survival, increased morbidity and mortality, and higher costs. The prevalence of CKD anemia increases with the progression of CKD to advanced stages, ranging from 40% in stage 3 to 70% in stage 5. High-dose ESAs pose safety concerns, including increased cardiovascular risk indicating that alternative therapies may be needed. The drugs we are testing in this research are Punarnava Mandura**Vati and Varuna-Shigru Kwathawhich are selected as trial drug. This has been selected for this study because it acts as an anemia-correcting agent owing to its several components. Studies has also revealed that this drug is well tolerated among the patients without any side effects and untoward effects compared to allopathic drug in one of the clinical trials. Triphala, Trikatu, Chitraka, *Vidanga,*and Pippalimula have appetizing, digestive, and carminative properties which improve digestive power and ultimately absorption of the drug. Amalaki, Danti, Pippali, Punarnava, Kushta, and Daruharidra are documented as drugs having immunomodulatory action and antioxidant properties having the potential of providing beneficial health effects in anemia. In the traditional medical system, Punarnava is widely recognized for both its diuretic and reno-protective properties. Triphala has anti-inflammatory and anti-oxidant activity. By significantly restoring serum levels of urea, uric acid, creatinine, and creatinine clearance, Terminalia chebula safeguards renal function. Through its antioxidant capacity, it also protects against oxidative damage and prevents nephrotoxicity. Varuna having properties like Kashaya, Madhura, Tikta & Katu Rasa & Ruksha & laghu Guna and it is Ushna, Sleshmahara, Mutrakruchhahara, Ashmarighna, Vatahara, Agnideepana. Shigru having properties like Katu, Madhura, Tikta Rasa, Katu Vipaka, Ushna Virya, Tikshna, Laghu and Ushna Guna. It is Kapha-vatanasaka, Sothhara & Medohara. The following investigations will be carried out before & after treatment to rule out other pathogenesis and assessment the status of subjects. Routine blood and urine investigation, Lipid Profile and Liver function test (LFT) & Renal function test (RFT) and iron markers. The participation in this research is entirely voluntary. In this present research work, 30 clinically diagnosed and confirmed cases of Anemia Associated with Non-Dialysis Dependent Chronic Kidney Disease will be taken. Here in Group A, the patients will be advised to take (Standard of Care) for the duration of 90 days. In Group B, the patients will be advised to take Punarnava Mandura in the dosage of 2 vati twice a day after meal with butter milk. Each Vati weigh 500mg. Varuna-Shigru Kwatha will be given in the dosage of 40ml twice a day empty stomach in the early morning and after 5 hours of lunch for the duration of 90 days in addition to the (Standard of Care). PathyaApathya will be advised to the patients. The duration of the treatment is 12 weeks along with 2 weeks follow up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
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 m
- •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
- •1.Red blood cell transfusion within 8 weeks prior to randomization.
- •Patient with a known history of myelodysplastic syndrome or multiple myeloma, or any kind of malignancies.
- •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. .
Outcomes
Primary Outcomes
1.Correction of anemia (Mean change of Hb, and ferritin from baseline in 90 days)
Time Frame: Group- A 90 Days | Group- B 90 Days
Secondary Outcomes
- 1.Improvement of quality of life (with (KDQOLâ„¢-36)) (Mean change of score from baseline in 90 days)(2.Progression of CKD (Mean change of e-GFR from baseline in 90 days))
Investigators
Seemaben Arvindbhai Kushwaha
Institute of Teaching and Research in Ayurveda Jamnagar