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CTRI Number  CTRI/2016/11/007489 [Registered on: 24/11/2016] Trial Registered Prospectively
Last Modified On: 22/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Ayurvedic management of chronic renal failure 
Scientific Title of Study   CLINICAL STUDY ON AYURVEDIC MANAGEMENT OF CHRONIC RENAL FAILURE 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Snehal S Patel 
Designation  PG Scholar 
Affiliation  J S Ayurveda college and P D Patel Ayurved Hospital 
Address  J S Ayurveda college College Road Nadiad
J S Ayurveda college College Road Nadiad
Kheda
GUJARAT
387001
India 
Phone  9687005283  
Fax    
Email  patelsonal131291@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manishkumar V Patel 
Designation  BAMS MD(AYU) 
Affiliation  J S Ayurveda college and P D Patel Ayurved Hospital 
Address  J S Ayurveda college College Road Nadiad
J S Ayurveda college College Road Nadiad
Kheda
GUJARAT
387001
India 
Phone  9979589865  
Fax    
Email  manishayu97@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Snehal S Patel 
Designation  PG Scholar 
Affiliation  J S Ayurveda college and P D Patel Ayurved Hospital 
Address  J S Ayurveda college College Road Nadiad
J S Ayurveda college College Road Nadiad
Kheda
GUJARAT
387001
India 
Phone  9687005283  
Fax    
Email  patelsonal131291@gmail.com  
 
Source of Monetary or Material Support  
J S Ayurveda college and P D Patel Ayurvedic hospital 
 
Primary Sponsor  
Name  J S Ayurveda college 
Address  J S Ayurveda college, college road, Nadiad 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Snehal S Patel  P D Patel Ayurveda Hospital  Kayachikitsa department Room No 204
Kheda
GUJARAT 		 9687005283

patelsonal131291@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
J S ayurved mahavidyalaya and P D Patel ayurveda hospital Institutional ethics committee for human research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  chronic renal failure patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayurvedic classical herbal formulation  1.Goká¹£uradi Guggulu orally – 3 tablets (each of 300 mg) 3 times in a day after food with warm water. 2.Varunadi kvatha orally – 40 ml 2 times in a day before food. 3.Rasayan churṇa orally – 3g, 3 times a day with water. 4.Bhumyamalaki churṇa orally– 3g, 2 times in a day after food with water. 5.Niruha basti (procto-colonic Punarnavadikvath 320 ml – in the morning, before lunch. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients of both sex between 18 to 65 years of age and having a confirm diagnosis of chronic kidney disease will be included.
2.Patients with GFR level < 60ml/min and persistent (present for > 3 months), laboratory investigations (i.e. raised serum creatinine and blood urea level)
 
 
ExclusionCriteria 
Details  1.Female patients having pregnancy, breast feeding or post-delivery period.
2.Patients of end stage renal disease
3.Patients who are on dialysis treatment from more than 1 month period. Patients who are already operated for renal transplantation and then having nephropathy.
4.Patients of hepato-renal insufficiency or renal insufficiency due to haemodynemic circulatory disorders and CCF.
5.Patients with some serious illness like cardio-vascular diseases, acute mental disorders, serious acute organic diseases, serious chronic co-morbidity, hypo or hyper thyroidism, liver or metabolic disorders etc.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of ayurvedic management in the patient of chronic renal failure  grade score of sign and symptoms along with laboratory investigations 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Not Applicable 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/01/2017 
Date of Study Completion (India) 25/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable this thesis work will yet to be submit 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   clinical evalution of effectiveness of ayurvedic management in chronic renal failure is the main object of study. patients will be selected from the P D Patel ayurved hospital, Nadiad. after the confirmation of the daignosis of the CRF with the help of classical sign and symptoms, they will be treated with following therapy.

1.Gokshuradi Guggulu (compound ayurvedic preparation: Gokshura + Guggulu + Triphala + Trikaá¹­u + Musta) orally – 3 tablets (each of 300 mg) 3 times in a day after food with warm water.

2.Varunadi kvatha (ingredients: Varunatvak +Bilvamula + Apamarga + Chitrakmula + Agnimanth + Shigru + Kantakari + Kalmegh + Karanja + Satavari) orally – 40 ml 2 times in a day before food.

3.Rasayan Churna (powder of Gokshur + Amalaki + Guduchi in equal quantities) orally – 3 gms, 3 times a day with water.

4.Bhumyamalaki churna orally– 3 g, 2 times in a day after food with water.

5.Niruha basti (procto-colonic administration of ayurvedic medicine) with Punarnavadikvath (decoction) 320 ml – in the morning, before lunch.
Total duration of treatment for main assessment period will be of 4 weeks.assessment will be done with the help of changes in gradation of the signs and symptoms of CRF and by observing improvement in the above mentioned investigations and eGFR before & after treatment. result will be analysed with student ’t’ test.
 
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