Role of Guduchyadi vasthi and Pathyapunarnavadi churna in the management of Jirna Vrikka roga(Chronic kidney disease) A Randomized standard controlled comparative study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1)Decrease in Serum Urea,Serum creatinine
研究概览
简要总结
Chronic kidney disease is one of the major clinical problem in speciality practice in the current scenario. Multiple factors are responsible for the manifestation of chronic kidney disease, however diagnosing the exact cause is not easy. It is also encountered as upadrava of hridroga and systemic hypertension, sometimes it is also reported to be drug induced. Initially the disease is asymptomatic later symptoms like pedal edema,anaemia,loss of appetite, tiredness and dyspnea are developed. Increasing number of patients presented signs and symptoms of Chronic kidney disease in Ayurvedic Kayachikitsa consultation has raised research question that whether it is possible to have a management module for such cases, either with modern medical intervention or as an add on therapy along with dialysis.
Hareethakyadi churna containing Hareetaki, Amalaki, Nisha, Saindhava, Vacha, Guda Pippali, Sunti,Vidanga which act as deepana,pachana,koshtashodhana,shothahara,pro metabolic anti-oxidant and nephron regeneration enzymatic action enhancer.Acharya Charaka has instructed to administer this yoga before the intervention of rasayana karma,hence in the present study this yoga is used as a poorvakarma for shodhana and rasayana chikitsa.
Vasthi is ardha chikitsa in Kayachikitsa speciality.It is trans rectal administration of judicial combination of shodhana drugs targeting dosha prathyanika chikitsa for vata dosha in particular.Invariably CKD is vatasthane kledavridhi hence utklishta dosha should be eliminated by nearest route for which ayugma vasti in yoga vasti schedule is selected to avoid snigdha oushadhis which may hamper ama kleda shotha harana effect.
Guduchyadi Kashaya contains Guduchi, padmaka, arishta, dhanyaka, raktachandana, it has a judicial combination of Tridoshahara, Raktaprasadaka, ama kleda meda shothahara tikta gana dravyas in all of them are rasayana in nature,hence will act as sapthadhathu poshana tiktapoushtika.When administered per rectal will bypass digestion and metabolism and directly the virya of dravya will spread in samana apana vyana sthana,hence it is administered per rectaly with vaiswanara churna6 which is a sodium based ushna katu tikta shothahara pandughna meda kledahara kalpa.
Pathyapunarnavadi churna is a poly herbomineral compound containing many of rasayana dravyas as Pathya,Punarnava,Guduchi,Bringaraja, Badara, Bala, Chitraka, Sunti, Kitta churna, Ajamoda in one kalpa which are tikta poushtika, Balya, Shothahara, Dhatwagni deepana.
OBJECTIVES OF THE STUDYPED
1) To study Jirna vrikka roga,Chronic kidney disease in detail along with critical understanding of pathophysiology of chronic kidney disease.
2) To document and analyse the effect of ongoing modern medical intervention of CKD.
3) To evaluate the effect of guduchyadi vasti and pathyapunarnavadi churna in the management of Chronic kidney disease.
4) To compare the effect of modern medical intervention with ayurvedic guduchyadi vasti and pathyapunarnavadi churna.
**DESIGN OF THE STUDY:**G IN THE MANAGEMENT OF CHRONIC
Study design – randomised standard controlled single blinded study
Study type – both interventional and observational,Prospective
Estimated enrolment –30
Allocation – randomised
Intervention model – double group assignment
Masking – single blinded
Primary purpose – treatment
Duration of study – 43 days
Follow up - 14 days after treatment
OBJECTIVE PARAMETER
v Blood – Serum urea
§ Serum creatinine
§ Hb% ,TC, DC, ESR
§ RBS
§ CRP
§ Serum Calcium,Sodium,Pottassium,Chloride
v Albuminuria
v Chest X-Ray
Blood Pressure
| DOURBALYA - Severity |
Grading
|No tiredness
0
|Occasional feeling of tiredness on light activity
1
|Constant feeling of tiredness on heavy activity
2
|Feeling tiredness all the time
3
| aruchi - Severity |
Grading
|No Aruchi
0
|Mild,without altering eating habits
1
|Oral inatake without causing any weight loss
2
|Associated with significant weight loss
3
|Not relieved by medication
4
| swasakrchratha - Severity |
Grading
|No breathlessness
0
|Breathlessness on upstairs/quick moving
1
|Breathlessness on light physical work
2
|Breathlessness on bed
3
| AGNIMANDYA - Severity |
Grading
|Take full diet and proper appetite at next meal hour
0
|Moderate appetite at next meal hour
1
|Delayed moderate appetite at next meal hour
2
|Delayed low appetite at next meal hour
3
| PADASOPHA - Severity |
Grading
|No sopha
0
|Slight pitting 2mm,disappears rapidly
1
|Deep pitting 4mm ,disappears 10-15 sec
2
|Deeper pitting 6mm may last > 1min
3
| PANDU - Severity |
Grading
|No pallor
0
|Pallor of conjunctiva and or mucous membrane
1
|Pallor of conjunctiva,mucous membrane,skin
2
|Pallor of conjunctiva,mucous membrane,skin,palmar creases
3
| AROHANA AYASA - Severity |
Grading
|No arohana ayasa
0
|Arohana ayasa on heavy activity
1
|Arohana ayasa on light activity
2
|Arohana ayasa on all activities
3
| MUTRAKSHAYA - Severity |
Grading
|No mutrakshaya
0
|Reduced Urine Output With less Water intake
1
|Reduced Urine Output Even with more water intake
2
|Not Relieved By Medication
3
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients diagnosed as CKD 2)Patients having serum creatinine less than 5mg/dl3)Patients with serum urea less than 85mg/dl 4)Patients who are fit for vasthi karma 5)Patients irrespective of religion,sex, socio economic status , occupation etc 6)Patients having Haemoglobin >8 gm% 7)Who signed the informed consent.
排除标准
- •Patients with multi organ failure 2)Patients who are on dialysis thrice in a week 3)Pregnancy,soothika will be excluded 4)Who are not fit for vasti karma will be excluded.
- •Patient with HIV ,HbsAg positive will be excluded.
- •Patient with Serum Creatinine >5 mg/dl, Serum Urea > 85 mg/dl, Haemoglobin <8 gm% 7)Who doesn’t sign for informed consent.
结局指标
主要结局
1)Decrease in Serum Urea,Serum creatinine
时间窗: 43 days
2)Improvement in Hb
时间窗: 43 days
3)Relief from symptoms
时间窗: 43 days
次要结局
- 1)Decrease in Serum Urea,Serum creatinine(2)Improvement in Hb)