Health Condition 1: N182- Chronic kidney disease, stage 2 (mild) Health Condition 2: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 3: N184- Chronic kidney disease, stage 4 (severe) Health Condition 4: N185- Chronic kidney disease, stage 5
Conditions
Interventions
Intervention1: Drug Name - Alfalfa Extract: Dose - 01 Sachet BID,
Route of administration - Oral
Frequency - BID
Duration Therapy - 90 days
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Amitojas Wellness Private Limited.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male and female subjects aged 18 years and above. 2. Subjects diagnosed with stage 2 â?? 5 Chronic Kidney Disease determined by eGFR (CKD-EPI Creatinine Equation 2021) level. 3. Subjects with serum creatinine level 4. Subjects willing to provide informed written consent
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Creatinine levels documented in the CRF at baseline, day 30, day 60 and day 90 (values and change from baseline).Timepoint: Time points should be - 04th week +/-2 days (Day 30), 08th week + 4 days(Day 60) and 12 week + 6days (day 90). | — |
Secondary
| Measure | Time frame |
|---|---|
| â?? Kidney Function Laboratory Test parameter levels documented in the CRF at baseline, day 30, day 60 and day 90 (values and change from baseline). â?? 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).Timepoint: NA | — |
Countries
India
Contacts
Public ContactDr D Tejoswaroop
Noah Therapeutics Pvt Ltd
Outcome results
None listed