Effect of Foxtail Millet Powder With Low Salts In Stage 3 Chronic Kidney Disease patients

A Controlled Open Label Single Arm Proof Of Concept Study To Evaluate The Safety Of De-NaPKC Foxtail Millet Powder With Low Salts In Stage 3 Chronic Kidney Disease In Indian Population. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058181

Enrollment

Registered

2023-10-03

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)

Interventions

Intervention1: De Mineralized Foxtail Millet Ready to Cook: Foxtail Millet 100gm powder taken in the morning instead of breakfast Total Duration: One Week Control Intervention1: Not applicable: Not ap

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1)Each patient will be monitored for any adverse drug reaction. Other Safety parameters includes monitoring for any change in the blood parameters. 2) Other parameters monitored include; Nausea, Vomiting, Gastritis, ability to consume 350 ml, skin reaction, able to pass stool comfortably, any event of hypoglycemic in diabetic patient, palpitation, hypertensive or hypotensive episodes and weight gain or loss.Timepoint: Day 0, Day 7, Day 15	—

Measure

Time frame

1)Each patient will be monitored for any adverse drug reaction. Other Safety parameters includes monitoring for any change in the blood parameters. 2) Other parameters monitored include; Nausea, Vomiting, Gastritis, ability to consume 350 ml, skin reaction, able to pass stool comfortably, any event of hypoglycemic in diabetic patient, palpitation, hypertensive or hypotensive episodes and weight gain or loss.Timepoint: Day 0, Day 7, Day 15

—

Secondary

Measure	Time frame
To monitor for any changes in any of the Laboratory parameters pre and post study.Timepoint: Day 0, Day 7, Day 15	—

Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

Thirumalai medical Centre, ki3

saheerose@gmail.com9443627722

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026