Investigating the effect and safety of NEERI KFT on impaired kidney functions and as an adjuvant with Nephrotoxic drugs

Not Applicable

Not yet recruiting

• Conditions: Disorder of kidney and ureter, unspecified. Ayurveda Condition: MUTRAVRUTAVATAH,

• Registration Number: CTRI/2023/07/054728
• Lead Sponsor: Aimil Pharmaceuticals (India) Ltd.

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-07
• Study Start: 2023-07-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Urine albumin-to-creatinine ratio (UACR) from Visit 1 (screening) to Visit 4 [Duration: 120 days]	Day -2, day 0, day 60, Day 120
•Mean change in estimated glomerular filtration rate (eGFR) from Visit 1 (screening) to Visit 4 [Duration: 120 days]	Day -2, day 0, day 60, Day 120

Secondary Outcome Measures

Name	Time	Method
•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]

Trial Locations

Locations (1)

Government Medical College & Government General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Government Medical College & Government General Hospital

🇮🇳Srikakulam, ANDHRA PRADESH, India

Dr SSVV Narasinga Rao

Principal investigator

9908611119

drnarasingaraossvv@yahoo.com