A Randomized Open-Label Comparative Clinical Trial Evaluating the Efficacy of Viratarvadi Kwath with Shuddha Shilajeet versus Varunadi Kwath with Gokshuradi Guggulu as Add-on Therapy in the Management of Mutraghata (Chronic Kidney Disease up to Grade3b)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
研究概览
简要总结
This study is an open-label, randomized comparative clinical trial designed to evaluate the effectiveness of two Ayurvedic treatment regimens in patients of Mutraghata (correlated with Chronic Kidney Disease up to Grade 3b) who are already receiving standard conventional care. The trial compares Viratarvadi Kwath with Shuddh Shilajeet against Varunadi Kwath with Gokshuradi Guggulu to assess their relative therapeutic benefits in improving clinical outcomes and kidney function.
Participants in the control group receive Varunadi Kwath (30 ml twice daily before food) along with Gokshuradi Guggulu (500 mg twice daily before food), while the trial group receives Viratarvadi Kwath (30 ml twice daily before food) combined with Shuddh Shilajeet (250 mg twice daily before food).
The total study duration 4 weeks.The study aims to generate comparative evidence on the efficacy of these classical Ayurvedic formulations as adjunct therapy in the management of early to moderate CKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of all genders.
- •Patients diagnosed with signs and symptoms of chronic kidney disease as per standard KDIGO criteria of known etiology, including diabetic nephropathy, hypertensive nephrosclerosis, chronic glomerulonephritis, or hereditary causes such as autosomal dominant polycystic kidney disease ADPKD shall be included.
- •Patient presenting with symptoms of Mutraghata.
- •The NAMASTE Portal, having serial no.
- •1258, the morbidity code EJ 3, corresponds to Mutraghata.
- •Patients of the age group 21 to 65 yrs.
- •with confirmed diagnosis of stage up to G3B as per standard KDIGO CRITERIA, eGFR greater than 30 ml per min.
- •per 1.73 square meters not having undergone RRT were included.
- •Subjects who are willing to sign the informed written consent.
- •Subjects who are not registered in any other research project in the last 12 weeks.
排除标准
- •1.HIV-associated nephropathy and transplant allograph failure 2.Renal Artery stenosis.
- •3.Neoplasm of Kidney.
- •4.History of previous kidney transplant.
- •5.Patients of Congenital Renal Diseases like Autosomal dominant and Recessive Polycystic Kidney disease, Congenital Nephrotic syndrome (Finnish type), Alport’s syndrome, Fabry,s disease and juvenile Nephronophthisis.
- •6.Patients with clinically diagnosed cardiorenal syndromes, including those with congestive heart failure, ischemic heart disease with reduced ejection fraction ,or acute or chronic cardiac conditions significantly contributing to renal dysfunction, shall be excluded from the study.
- •7.Uncontrolled diabetes HbA1C greater than 9 percentage and uncontrolled HTN greater than 160/100mmHg. 8.Patients suffering from Tuberculosis, Malignancy, Pregnancy and lactation, or any other systemic illness.
研究者
Muskan Goyal
All India Institute of Ayurveda