| CTRI Number |
CTRI/2026/04/109253 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
23/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Recognizing Efficacy and Safety of Syrup Nephrogrit in Patients with Chronic Kidney Disease (CKD). |
|
Scientific Title of Study
|
To Evaluate the Efficacy and Safety of Syrup Nephrogrit in Patients with Chronic Kidney Disease (CKD) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Kumar |
| Designation |
Consultant |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
Tulsidas Marg Turiyaganj Hospital Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9509074322 |
| Fax |
|
| Email |
deepakwhynot@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Kumar |
| Designation |
Consultant |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
Tulsidas Marg Turiyaganj Hospital Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9509074322 |
| Fax |
|
| Email |
deepakwhynot@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar Tiwari |
| Designation |
Assistant Professor |
| Affiliation |
Goel Ayurvedic Medical College and Hospital, Lucknow |
| Address |
Village- anaura kala,Faizabad road, near indira canal, Lucknow
Lucknow
UTTAR PRADESH
226028
India |
| Phone |
9450097351 |
| Fax |
|
| Email |
ajaytiwari2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute Name- State Ayurvedic College and Hospital
Tulsidas Marg, Turiyaganj, Lucknow-226004 (U.P.), India
Email id - statayurlko@gmail.com
statayurlko@yahoo.com |
|
|
Primary Sponsor
|
| Name |
Vrind Formulations Pvt Ltd |
| Address |
Adress- 1/246, Viram Khand, Gomati Nagar, Lucknow-226010 (U.P.), India. |
| Type of Sponsor |
Other [Private Limited] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Kumar |
State Ayurvedic College and Hospital |
Tulsidas marg, Turiyaganj,Lucknow-226004 (U.P.),India
Lucknow
UTTAR PRADESH |
9509074322
deepakwhynot@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| office of institutional ethics commitee state ayurvedic college and hospital lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N181||Chronic kidney disease, stage 1. Ayurveda Condition: MEDOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Nephrogrit Syrup, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age- 30-65 Yrs
2.History of reduction of kidney function must be presented over 3 months or more.
3.Serum Creatinine level above 1.4 mg/dl and below 5.5 mg/dl
4.Serum Urea level above 40 mg/dl and below 150 mg/dl
5.Patient having Hb % more than 7.5 gm/dl
6.GFR 30-90ml/min./1.73m2
7.BUN (Blood Urea Nitrogen) above 18.6mg/dl and below 46.8mg/dl |
|
| ExclusionCriteria |
| Details |
1.Age below 30 and above 65 years.
2.Serum Creatinine level below 1.4 mg/dl and above 5.5 mg/dl.
3.Serum Urea level below 40 mg/dl and above 150 mg/dl.
4.Patient having Hb % less than 7.5 gm/dl.
5.GFR beyond the limit of 30-90ml/min/1.73m2.
6.BUN (Blood Urea Nitrogen) below 18.6mg/dl and above 46.8mg/dl.
7.Patient having frequent repeated dialysis.
8.Uncontrolled Diabetes mellitus.
9.Malignant hypertension
10.Congenital disease of Kidney: Polycystic kidney disease.
11.Renal artery or vein obstruction
12.Liver failure
13 Pancreatitis
14.Sepsis
15.Prostate carcinoma
16.Grade-III Prostate
17.Heart Failure.
18.Transplant allograft failure
19.Microangiopathy like DIC, TTP
20.Systemic disease like SLE, lymphoma, leukaemia, sarcoidosis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in Glomerular Filtration Rate (GFR)
• Measurement: eGFR calculated from serum creatinine
2.Change in Serum Creatinine
• Measurement: Serum creatinine (mg/dl)
3.Change in Blood Urea
• Measurement: Blood urea (mg/dl)
4.Change in Blood Urea Nitrogen (BUN)
• Measurement: BUN (mg/dl)
|
1- Serum Creatinine - (Baseline, Day 30, Day 60, Day 90)
2- Blood Urea - (Baseline, Day 30, Day 60, Day 90)
3- Glomerular Filtration Rate (GFR) - (Baseline, Day 30, Day 60, Day 90)
4- Blood Urea Nitrogen (BUN)- (Baseline, Day 30, Day 60, Day 90) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The following parameters were assessed at the indicated timepoints:
1.Symptom score: Composite score (0-3) of non-essential criteria (anemia, oliguria/anuria, burning micturition, pruritus, edema, thirst, difficulty in micturition) at baseline, Day 30, Day 60, and Day 90.
2.Hemoglobin level: Hb% and anemia grade at baseline and Day 90.
3.Urine parameters: Proteinuria/albuminuria and routine urine microscopy at baseline and Day 90.
4.Dialysis/renal replacement events: New dialysis initiation or hospitalization for renal failure during the study and 1-month follow-up.
5.Quality of life/patient global impression: Patient self-assessment (improved/unchanged/worse) at Day 90 and follow-up. |
Baseline, Day 30, Day 60, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 2 |
|
Date of First Enrollment (India)
|
04/05/2026 |
| 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="2"
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 long-term condition where the kidneys gradually lose their ability to function properly. It often develops silently and may lead to serious complications such as anaemia, swelling, and heart problems. In India, CKD is becoming increasingly common, and there is a need for safe and effective treatments that can slow its progression. This study will test an Ayurvedic formulation called Nephrogrit Syrup in patients with CKD. Nephrogrit is made from natural herbs traditionally known to support kidney health, improve urine flow, and reduce swelling. The trial will include 150 patients aged 30–65 years who have moderate kidney impairment. Each patient will receive 20 ml of Nephrogrit twice daily after meals for 90 days, with regular check-ups at 30, 60, and 90 days, followed by a short follow-up period after treatment. The main aim of the study is to see whether Nephrogrit can help improve kidney function by reducing blood urea and creatinine levels and maintaining glomerular filtration rate (GFR). The study will also look at improvements in symptoms such as weakness, swelling, difficulty in urination, and itching. Safety will be monitored throughout the trial. By combining traditional Ayurvedic knowledge with modern clinical methods, this study hopes to provide evidence for the role of Nephrogrit Syrup in managing CKD and improving patients’ quality of life. |