Effect of Foxtail Millet Powder WithLow Salts In Stage 3 Chronic Kidney Disease patients
- Conditions
- Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)
- Registration Number
- CTRI/2023/10/058181
- Lead Sponsor
- BR Medical Research and software solutions OPC Private limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Willing and able to provide written informed consent prior to
performing study procedures.
2. Patients between the age of 45 to 65 years, male or female.
3. Patients in stage III CKD and who are on salt restricted diet and
able to drink 350 ml/day.
4. Females must be non-pregnant / non-lactating and practicing
adequate birth control measures if not menopausal.
5. Patient should have not participated in any other clinical trial
during the past 3 months.
1. Patient who are unable to consume solid and liquid orals.
2. Having active infection
3. Very high level of creatinine ( >4 mg/dl).
4. Hypersensitivity to test product.
5. History of drug or alcohol abuse.
6. Consideration by the investigator, for any reason, that the
subject is an unsuitable candidate to receive study treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Each patient will be monitored for any adverse drug reaction. <br/ ><br>Other Safety parameters includes monitoring for any change <br/ ><br>in the blood parameters. <br/ ><br> <br/ ><br>2) Other parameters monitored include; Nausea, Vomiting, <br/ ><br>Gastritis, ability to consume 350 ml, skin reaction, able to <br/ ><br>pass stool comfortably, any event of hypoglycemic in <br/ ><br>diabetic patient, palpitation, hypertensive or hypotensive <br/ ><br>episodes and weight gain or loss.Timepoint: Day 0, Day 7, Day 15
- Secondary Outcome Measures
Name Time Method To monitor for any changes in any of the Laboratory parameters pre <br/ ><br>and post study.Timepoint: Day 0, Day 7, Day 15