A comparative study to evaluate the efficacy of Amritadi kwath and Gokshurak Rasayana in management of Chronic kidney disease ( Mutravahasrotas Dusti) - Open Labelled Randomized Control Clinical Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in e-GFR which is determined through calculations based on laboratory reports.
研究概览
简要总结
Chronic kidney disease is defined as the presence of an abnormality in kidney structure or function persisting for more than 3 months, with or without decreased GFR, manifest by either pathological abnormalities or markers of kidney damage, including abnormalities in the composition of the blood or urine, or abnormal imaging tests or GFR less than 60 mL/min/1.73 m2 with or without kidney damage. The worldwide prevalence of CKD (all stages) is estimated to be between 8 to 16%, a figure that may indicate millions of deaths annually. The overall prevalence of CKD in SEEK INDIA cohort was observed to be 17.2% population Prevalence of CKD stage 1 is 7%, stage 2 is 4.3%, stage 3 is 4.3%, stage 4 and stage 5 is 0.8% respectively.
Although there is no description of CKD in Ayurveda Classics as per disease of MutravahaSrotas, but disease described as per the manifestation from Hetu, Dosha, Dhatu, Dushti, Lakshana, etc. In Ayurveda kidney is called Vrikka. Origin of Vrikka is from Rakta and Meda dhatu. In Ayurveda, toxins of urine is called Mala. According to Ayurvedic principle of treatment, our aim is to treat Rakta, meda and mala. Hence, CKD is the collaborative progression of Rasavaha, Raktavaha, Mamsavaha, Medovaha-SrotasDusti which reflects through MutravahaSrotas including Ojas Dusti.
In Ayurvedic context*, Acharya Charaka* stated that basti (urinary bladder) and Vankashna ( groin) as Mula of Mutravaha Srotas .Similarly, according to Acharya Sushruta ,urine formation occurs in Pakvashayagat sthana which is secreted through Gavini’s(ureters) and stored in Basti(urinary bladder). He also states that Basti regulates the *Kleda (*maintain water-electrolyte Balance which is the function of Kidney) and collection of *mutra.*So, this manifests that formation and excretion of Mutra is chain mechanism of Mutravaha Srotas where functions of all organs related to one another, if there is pathology arises in any part of Mutravaha Srotas leads to Mutravaha Srotas Dusti.
The Lakshana of Mutravaha Srotas Dusti, mentioned by Acharya Charak described as –
Atisrashtammutra(Increase in frequency of urine)
Alpa-Alpa Abhikshnam (Oliguria)
AtivibadhamMutra **(**Anuria)
Bahalammutram(Increase in volume of urine)
Sashoolam Mutradrashtam (Dysuria)
Group A: Amritadi Kwath 40ml 2 times a day empty stomach in morning,2hours before meal in evening
Group B: Gokshurak Rasayana 5gms, 2times a day after meals in morning and evening
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
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient diagnosed with sign &symptoms of CKD of stage 1,2, 3a & 3b; with or without anemia as per standard KDIGO-CRITERIA.
- •2.Patient presenting with minimum 3 symptoms of Mutravaha Srotas Dusti along with symptoms of Pandu.
- •3.Patient having controlled DM2 FBS less than or equal to 130mg/dl, PPBS less than or equal to 200mg/dl, HbA1C less than 7% having CKD symptoms with or without HTN or DM
- •4.Age more than or equal to 25yrs and less than or equal to 65yrs.
- •Patient must be either male or female.
- •6.Subjects who are willing to sign the informed consent.
- •7.Subjects who are not registered in any other research project.
- •Patient having cause of chronic kidney disease either pre-renal causes or renal causes.
排除标准
- •1.Patient take insulin for blood glucose control or HbA1C is more than or equal to 7%.
- •2.Stage 4 HTN i.e. Patient has B.P.≥160/100mmHg with medication.
- •3.Patient undergoes Dialysis or any renal transplant.
- •4.Urinary-tract obstructions like Benign Prostatic Hypertrophy, Renal calculi tumours or diseases Such as HIV-patients, Hepatitis-B, Hepatitis-C.
- •5.Lactating Mothers and in pregnant females.
- •6.Patients suffering from major diseases- a.
- •coronary artery diseases (CAD) b.
- •Malignancy c.
- •Chronic liver disease d.
- •Tuberculosis f.
- •Sexually transmitted disease.
结局指标
主要结局
Improvement in e-GFR which is determined through calculations based on laboratory reports.
时间窗: 30 days
次要结局
- Reduce Sr. Creatinine, Serum Blood Urea,(Improvement in Sr. Electrolytes (Na+, K+, Ca2+, PO4, HCO3-),)
研究者
Dr Anjali
Chaudhary Brahm Prakash Ayurved Charak Sansthan