| CTRI Number |
CTRI/2023/07/054728 [Registered on: 04/07/2023] Trial Registered Prospectively |
| Last Modified On: |
03/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Investigating the effect and safety of NEERI KFT on impaired kidney functions and as an adjuvant with Nephrotoxic drugs |
|
Scientific Title of Study
|
An Open-Label, Non-Randomized, Single Center Prospective Study to Evaluate the Efficacy & Safety of a polyherbal NEERI® KFT formulation in patients with impaired kidney functions and as adjuvant with Nephrotoxic drugs. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SSVV Narasinga Rao |
| Designation |
Assistant Professor |
| Affiliation |
Govt. Medical Collège & Govt. General Hospital |
| Address |
Govt. Medical Collège & Govt. General Hospital
Research wing
2nd Floor, Beside FM Ward,
Srikakulam- 532001, Andhra Pradesh- India.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9908611119 |
| Fax |
|
| Email |
drnarasingaraossvv@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hasan Ali Ahmed |
| Designation |
Director |
| Affiliation |
Xplora Clinical Research Services Pvt. Ltd |
| Address |
Xplora Clinical Research Services Pvt. Ltd.
#252, 13th cross, wilson garden, Bangalore.
Bangalore
KARNATAKA
560027
India |
| Phone |
9886012598 |
| Fax |
|
| Email |
hasan@xplorahealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Hasan Ali Ahmed |
| Designation |
Director |
| Affiliation |
Xplora Clinical Research Services Pvt. Ltd |
| Address |
Xplora Clinical Research Services Pvt. Ltd.
#252, 13th cross, wilson garden, Bangalore.
Bangalore
KARNATAKA
560027
India |
| Phone |
9886012598 |
| Fax |
|
| Email |
hasan@xplorahealth.com |
|
|
Source of Monetary or Material Support
|
| Aimil Pharmaceuticals (India) Ltd. |
|
|
Primary Sponsor
|
| Name |
Aimil Pharmaceuticals (India) Ltd. |
| Address |
2994/4, Street no. 17, Ranjeet Nagar, Patel Nagar,
New Delhi – 110008
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 SSVV Narasinga Rao |
Government Medical College & Government General Hospital |
Research Wing,
2nd Floor, Beside FM Ward,
Srikakulam-532001, Andhra Pradesh- India
Srikakulam
ANDHRA PRADESH |
9908611119
drnarasingaraossvv@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, GMC &GGH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N289||Disorder of kidney and ureter, unspecified. Ayurveda Condition: MUTRAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: NEERI KFT, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -NA |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Participants of either sex aged 21 to 75 years
2)Participants with the diagnostic reports for nephritis, poor renal functions, and nephropathy.
3)Participants with Sr. creatinine (≥ 1.35 mg/dL) and blood urea (≥24 mg/dL) levels above the normal range.
4)Individuals with stage I-IV CKD, with or without dialysis.
5)Willing to sign informed consent and comply with the requirements of the study protocol.
|
|
| ExclusionCriteria |
| Details |
1)Participant with stage-V kidney failure
2)History of organ transplantation including renal transplantation
3)Individuals with mental disorders, severe infections, anaemia, and electrolyte imbalance, complicated or uncontrolled diabetes and hypertension
4)Subjects with active or past events of cerebral infarction, cerebral haemorrhage, myocardial infarction, unstable angina, heart failure or transient ischemic attack.
5)Impaired hepatic function with elevated SGOT and SGPT levels of 2.5 -fold the upper limit of normal level or above.
6)Severe edema, massive pleural or peritoneal effusion
7)Use of corticosteroids or immunosuppressive drugs in the previous 3 months
8)Allergy to the trial drugs
9)Participation in other clinical studies
10)Refuse to participate, or signed informed consent
11)Pregnant or lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Mean change in estimated glomerular filtration rate (eGFR) from Visit 1 (screening) to Visit 4 [Duration: 120 days]
•Urine albumin-to-creatinine ratio (UACR) from Visit 1 (screening) to Visit 4 [Duration: 120 days]
|
Day -2, day 0, day 60, Day 120 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Mean change in Sr. creatinine from Visit 1 (screening) to Visit 4 [Duration: 120 days]
•Mean change in blood urea nitrogen (BUN) from Visit 1 (screening) to Visit 4 [Duration: 120 days]
•Mean change in serum potassium (K) levels from Visit 1 (screening) to Visit 4 [Duration: 120 days]
•Mean change in urine albumin & urinary pH, from Visit 1 (screening) to Visit 4 [Duration: 120 days]
•Mean change in total serum protein from Visit 1 (screening) to Visit 4 [Duration: 120 days]
•Change in quality of life (QoL) evaluated using Short Form 36-item Health Survey (SF-36) from Visit 1 (screening) to Visit 4 [Duration: 120 days]
•Mean changes in the serum levels of SGPT and SGOT from Visit 1 (screening) to Visit 4 [Duration: 120 days]
•Mean changes in the CBC parameters from Visit 1 (screening) to Visit 4 [Duration: 120 days]
•Occurrences and frequencies of adverse and serious adverse events during the study period
|
Day -2, day 0, day 60, Day 120 |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/07/2023 |
| 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 slow-onset, multifactorial disease characterized by changes in kidney structure or function. It is a major public health issue in both developed and developing countries. In modern medicine, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, and calcium channel blockers are primarily used to slow the progression of CKD.NEERI® KFT is a polyherbal oral liquid formulation for the treatment of kidney conditions, including nephritis, nephropathy, impaired GFR, poor renal functions, oedema, & other renal disorders. An Open-Label, Non-Randomized, Single Center Prospective Study to Evaluate the Efficacy and Safety of a Polyherbal NEERI® KFT Formulation in Patients with Impaired Kidney Functions and as an adjuvant with Nephrotoxic drugs. Age Criteria of the study is 21 to 75 years of either sex. A total of 30 evaluable subjects are planned to enrol in this study. Recruitment and treatment of subjects is expected to be performed in a single study center. The study will last approximately 120 days (4 months). Each patient will receive 120 days of treatment. |