CTRI/2023/07/054728Not yet recruitingPhase 4
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.
Aimil Pharmaceuticals (India) Ltd.0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
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
Investigators
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