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CTRI Number  CTRI/2021/01/030193 [Registered on: 01/01/2021] Trial Registered Prospectively
Last Modified On: 01/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Panchakarma]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Erandamooladi Basti along with Ayurvedic Multi Drug Therapy in the Treatment of Chronic Kidney Disease 
Scientific Title of Study   Efficacy of Ayurvedic Multi Drug Therapy along with Erandamooladi Basti in the Management of Chronic Kidney Disease-An Open Labelled Randomized Controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Remya Kuttan 
Designation  MD Scholar 
Affiliation  IPGT and RA 
Address  Department of Panchakarma IPGT and RA 4th Floor Jamnagar Gujarat

Jamnagar
GUJARAT
361008
India 
Phone  9846793260  
Fax    
Email  remyasijugopal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Anup Thakar 
Designation  HOD and Director 
Affiliation  IPGT and RA 
Address  Department of Panchakarma IPGT and RA 4th Floor Jamnagar Gujarat

Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Anup Thakar 
Designation  HOD and Director 
Affiliation  IPGT and RA 
Address  Department of Panchakarma IPGT and RA 4th Floor Jamnagar Gujarat

Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Source of Monetary or Material Support  
Opposite Reliance Smart Department of Panchakarma, IPGT and RA ,GAU , Jamnagar 361008 
 
Primary Sponsor  
Name  IPGT and RA 
Address  IPGT and RA GAU Jamnagar Gujarat India 361008 
Type of Sponsor  Research institution and hospital 
 
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 
Remya kuttan  PG Hospital IPGT and RA   Department of Panchakarma IPGT and RA 4th Floor Jamnagar Gujarat
Jamnagar
GUJARAT 
9846793260

remyasijugopal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (2) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (3) ICD-10 Condition:N183||Chronic kidney disease, stage 3 (moderate). Ayurveda Condition: MUTRAGHATAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Basti along with Ayurvedic Multi drug therapy  In Group A patients will be given Ayurvedic oral medications and Panchakarma procedure Basti Oral medications include dipana pachana with Trikatu choornam 3-5gm tds for3-5daysfollowed by VarunaSigru Kwath 40ml bd before food Gokshuradiguggulu 2tds before food Guduchyadisamana choornam 3gm bd after food gokshura choornam 3gm bd before food for 20-22 days Panchakarma procedure as Erandamooladi Bastiin which Niruha Basti for 12 days and Anuvasana Basti for 4 days 
Comparator Agent  Control group  Group B consists of standard controlled group taking Allopathic medications throughout the study for 20-25 days.It will include Antihypertensive medications Drug that reduce Metabolic Acidosis Calcium supplements Iron supplements Vitamin B complex medicines 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients having signs and symptoms of chronic kidney disease.
2. Patients of both genders between 18-60yrs of age.
3. Patients willing and able to participate.
4. Patients with serum creatinine level between1.2- 6 mg/dl will be included in the study.
5. Patients with serum urea level with in 120mg/dl
6. Patients who are yogya for basti karma.
 
 
ExclusionCriteria 
Details  1. Female patients having pregnancy, breast feeding or post-delivery period.
2. Patients of end stage renal failure.
3. Patients who are on dialysis treatment for more than 1-month period.
4. Patients who are already operated for renal transplantation and then having nephropathy.
5. Patients of hepato-renal insufficiency or renal insufficiency due to hemodynamic circulatory disorders and CCF.
6. Patients having some serious illness like cardio-vascular diseases, acute mental disorders, serious acute organic diseases, serious chronic co-morbidity, hypo or hyper thyroidism.
7. Patients having haemoglobin concentration below 8gm.
8. Having uncontrolled Hypertension(systolic<180mm/Hg, diastolic<100mm/Hg) and Diabetes mellitus (FBS-<200mg/dl)
9. Patients with serum urea level above 120mg/dl
10. Patients having symptoms of Uremia.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in serum creatinine and increase in eGFR   After 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in signs and symptoms of CKD  After 4 week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Purpose of the Research:

Chronic Kidney Disease refers to an irreversible destruction of the kidney function persistent for more than or equal to3months.Prevalence of this disease is about 250 million people in the world.In India prevalence is about 800 per million population.The modern management of CKD  is worth costly and the ultimate remedy is renal transplantation.The increase in the prevalence of kidney disease progressing to End Stage Renal Disease and the consequent financial burden of renal replacement therapy create imbalance in the economy of Developing country like India.Moreover,main causes of CKD are Diabetes and Hypertension.By 2030,India is expected to have worlds largest population of patients  with Diabetes.So it’s a humble effort to find an alternate treatment for safe,effective as well as cheaper medication when compared to modern medicine.

The present study  aims to asses and compare the effect of Ayurvedic multi drug therapy along with Erandamooladi Basti in the management of Chronic Kidney Disease.

Information about Trial drug and Panchakarma procedure:

The trial drug includes Kashayam of Varuna Sigru(40ml two times daily ,before food),Gokshuradi Guggulu(two tab thrice ,before food),Guduchyadi Choornam(5gm twice,after food)and Gokshuradi Choornam(3gm twice before food) internally for 20-22 days.The Panchakarma procedure we are testing in this study is the Erandamooladi Basti(internal administration of medicated Basti dravya through anal route)for 16 days.The trial drug formulations used in this study are described in Ayurvedic classical texts and are prepared from the Pharmacy of Gujrat Ayurved University,Jamnagar and none of them has reported any side effects.We assure that this formulation has been prepared with complete care and purification methods if required.

Description of Research Process:

In the present study,participants which clinically diagnosed and confirmed cases of Chronic Kidney Disease will be divided in to two groups,with a minimum of 15 patients in each group.

Group A:

Participants willing to take Ayurvedic multi drug therapy and Erandamooladi Basti are included in Group A.The treatment protocol includes trikatu choornam 3-5gm for 3-5 days for improving digestive power,Gokshura,VarunaSigru kwath di guggulu,Guduchyadi Samana choornam,Gokshura choornam for 20-22days(doses as above mentioned).Panchakarma procedure includes internal administration of medicated Erandamooladi Basti dravya for 12days and Anuvasana Basti(using medicated thila thaila for 4 days) in the order of three Erandamooladi Basti (480ml)followed by one thila thaila Basti(60ml).

Group B:

Participants willing to take conventional medicine(Allopathic)medications are included in this group.The medications include AntiHypertensive drugs,drugs which reduces metabolic acidosis,Iron supplements,Vitamin B Complex medications,Calcium tablets etc.This group considered to be the standard controlled group.

Side Effects:

We will follow closely and keep track of any unwanted effects .Till now ,no side effects had been reported on  the internal administration of mentioned trial drugs and the administration of Erandamooiadi Basti procedure.

Benefits:

This project will help us to resolve the research question.There may not be any benefit for the society at this stage of the research,but future generations are likely to be benefitted,as it helps to find out proper treatment protocol for the management of Chronic Kidney Disease.

The information that we collect from this research project will be kept confidential,all outcomes will be noted in tabular form and appropriate statistical tests will be applied to compare the effect.

 
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