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CTRI Number  CTRI/2024/11/076877 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 09/11/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Clinical study to evaluate the effect of herbal product Alfalfa on chronic Kidney disease to evaluate change in the average levels in serum creatinine. 
Scientific Title of Study   Evaluation of efficacy and safety of CKD Formulation in the management of Chronic Kidney Disease: A prospective, multicenter, interventional study. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
LMI-CKD Version -01 Dated : 07 Oct 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MrNUpendra Chowdary 
Designation  Director 
Affiliation  Noah Therapeutics Pvt Ltd 
Address  Noah Therapeutics Private Limited D.No.7-1-645/A, Sanathnagar, Erragadda, Hyderabad, Telangana -(India)

Hyderabad
TELANGANA
500018
India 
Phone  919177024456  
Fax  040-29884201  
Email  Upendra@noahtherapeutics.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr D Tejoswaroop 
Designation  Medical Monitor 
Affiliation  Noah Therapeutics Pvt Ltd 
Address  Noah Therapeutics Private Limited D.No.7-1-645/A, Sanathnagar, Erragadda, Hyderabad, Telangana -(India)

Hyderabad
TELANGANA
500018
India 
Phone  919958509329  
Fax  040-29884201  
Email  tejoswaroopd@noahtherapeutics.com  
 
Details of Contact Person
Public Query
 
Name  Dr D Tejoswaroop 
Designation  Medical Monitor 
Affiliation  Noah Therapeutics Pvt Ltd 
Address  Noah Therapeutics Private Limited D.No.7-1-645/A, Sanathnagar, Erragadda, Hyderabad, Telangana -(India)


TELANGANA
500018
India 
Phone  919958509329  
Fax  040-29884201  
Email  tejoswaroopd@noahtherapeutics.com  
 
Source of Monetary or Material Support  
Noah Therapeutics Pvt Ltd, D.No.7-1-645/A, Sanathnagar, Erragadda, Hyderabad, Telangana -500018 (India)  
 
Primary Sponsor  
Name  Amitojas Wellness Private Limited. 
Address  #3-100-55/739, Block-A, 2nd Floor, JK Arcade Jayaberi Park, Kompally, Hyderabad, Telangana – 500014, India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Satish Kumar  Gandhi Hospital  Musheerabad Main road, Secunderabad, Nephrology Department, Room no 314, Unit 03, Telangana 500025, India.
Hyderabad
TELANGANA 
9908523185
040-27505566
vasesantosh@gmail.com 
Dr Pradeep Kumar K  Mahabubnagar cancer hospital  Opp Citi Scan center, General Medicine Department, Unit -01 Division, Room No 216, Rajendranagar, Mahabubnagar,Telangana,509001, India.
Mahbubnagar
TELANGANA 
9902280779
08542221151
kpkreddy.medonco@gmail.com 
Dr Krishna Kasam  TX Hospitals  Road No 12, Banjara Hills, Internal Medicine department, Block 01 unit, Room No 08, Hyderabad, Telangana, 500034, India.
Hyderabad
TELANGANA 
9885232820
040-66529999
drkrishnakasam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional ethics committee of Mahabubnagar cancer Hospital  Approved 
Institutional Ethics Committee, Gandi Medical college and General Hospital  Submittted/Under Review 
institutional ethics committee, TX hospitals  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N182||Chronic kidney disease, stage 2 (mild), (2) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (3) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (4) ICD-10 Condition: N185||Chronic kidney disease, stage 5,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Drug Name - Alfalfa Extract  Dose - 01 Sachet BID, Route of administration - Oral Frequency - BID Duration Therapy - 90 days 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Male and female subjects aged 18 years and above.
2.
Subjects diagnosed with stage 2 – 5 Chronic Kidney Disease determined by eGFR (CKD-EPI Creatinine Equation 2021) level.
3.
Subjects with serum creatinine level ≤ 5 mg/dL
4.
Subjects willing to provide informed written consent 
 
ExclusionCriteria 
Details  1.
Pregnant, planning to become pregnant or breastfeeding women.
2.
Subjects with significant medical/surgical condition which requires long-term treatment.
3.
Current or past history of a serious illness including, seizures, major psychiatric illness, structural brain disease, liver or kidney failure, organ transplantation, rheumatoid arthritis, uncontrolled hypertension, uncontrolled diabetes or malignancy, cardiovascular event in the last three months.
4.
Alcohol or substance abuse.
5.
Allergy or sensitivity to any of the ingredients in the study treatment.
6.
Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly.
7.
Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Serum Creatinine levels documented in the CRF at baseline, day 30, day 60 and day 90 (values and change from baseline).  Time points should be - 04th week +/-2 days (Day 30), 08th week + 4 days(Day 60) and 12 week + 6days (day 90). 
 
Secondary Outcome  
Outcome  TimePoints 
✓
Kidney Function Laboratory Test parameter levels documented in the CRF at baseline, day 30, day 60 and day 90 (values and change from baseline).
✓
eGFR (CKD-EPI Creatinine Equation 2021) levels documented in the CRF at baseline, day 30, day 60 and day 90 (values and change from baseline). 
NA 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/12/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Chronic kidney disease (CKD) is a syndrome defined as persistent alterations in kidney structure, function or both with implications for the health of the individual. It is a non-communicable disease usually caused by diabetes and hypertension. Cardiovascular disease is the major cause of the early morbidity and mortality sustained by patients with CKD. Characteristic features of chronic kidney disease (CKD) involve progressive destruction of the renal parenchyma and the loss of functional nephrons. The loss of functional nephrons triggers molecular and cellular events responsible for compensatory growth of the remaining ones. These mechanisms may become pathological and result in the development of renal lesions and lead to end-stage renal disease (ESRD).

According to lancet globally, in 2017, 1·2 million people died from CKD. The global all-age mortality rate from CKD increased 41·5% between 1990 and 2017. However, in India as we have no renal registry or a standardized diagnostic method the actual burden is still unknown and it varied widely from 2.9% to 16.54% in different studies using different methods. Lack of both awareness and treatment facilities make diagnosis possible, only at late stages of 4 or 5.

The three treatment options for CKD are medical management, dialysis or transplant. There is no cure for CKD. Advanced CKD needs dialysis or kidney transplant to maintain life. Because of the high cost and problems of availability, in India only 5 -10% of kidney patients get treatment like dialysis and kidney transplant, while the rest die without getting any definitive therapy. Therefore, early detection and meticulous conservative medical management is the only feasible and less expensive way to manage CKD and delay the need for dialysis or transplant.

Also it is known that, environmental factors also have a role in human health of which nutrition is of utmost importance, since dietary habits heavily influence the incidence and progression of a variety of pathologies, particularly non-communicable diseases (NCDs). The importance of nutrition in nephrology, with a special focus on protein and salt restriction, has long been recognized as crucial for the management of CKD patients, along with pharmacological therapy to slow down disease progression and correct the signs and symptoms of uremia In a systemic and functional view of nutrition, controlling low-grade chronic inflammation is crucial for renal damage prevention. In this regard, functional molecules and nutrients such as fiber and fatty acids, and plant-derived nutraceuticals, play a key role, either influencing pro- and anti-inflammatory pathways or acting at the gut mucosal level. A variety of nutraceutical products are being promoted as being able to support, protect and or heal renal injuries. The mechanisms by which these nutraceuticals may benefit patients with chronic kidney disease include – reduction of inflammation, modulation of oxidative stress, and inhibition of interstitial fibrosis, promotion of renal blood flow and glomerular filtration rate and stimulation of tubular regeneration. In this study we intend to evaluate the efficacy and safety of nutraceutical CKD Formulation in the management of chronic kidney disease.


 
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