| 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
|
|
|
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
|
|
|
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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