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

Phase 3

Not yet recruiting

Lead Sponsor: BR Medical Research and software solutions OPC Private limited

Brief Summary: The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 11 Participants will be randomized into single arm.

Day 0: Baseline Medical history, physical examination, vitals ( weight, height,temperature) and Blood parameters will be monitored (CBC, FBS, PPBS, RFT, LFT, TFT, fluoride, CRP, Angiotensin converting enzyme level, Urine Routine ) and ECG

Day 1-7 : Patients will be on standard salt restricted diet as advised by the investigator. On day 8 Medical hiatory, physical examination, vitals ( weight, height, temperature) and Blood parameters will be monitored (CBC, FBS, PPBS, RFT, LFT. TFT, flouride, CRP, Angiotensin converting enzyme level, Urine Routine) and ECG

Day 7-14 De-NaPKC Foxtail millet with low salt first diose is instituted orally once daily in the morning insted of breakfast for 7 days. Normal Standard diet (salt restricted) will be followed for the rest of the meals for lunch and dinner.

Day 15: Medical examintaion , vitals and all blood parameters taken on screening will be monitored.

Primary Outcome

1) Adverse drug reaction

2) Safety Parameters

3) Nausea, Vomiting, Gastritis, ability to consume 350 ml, skin reaction, able to pass stool comfortably and event of hypoglycemic in diabetic patient, palpitation, hypersenetive or hyposenstive episodes, weight gain or loss

Recruitment & Eligibility

Inclusion Criteria

Willing and able to provide written informed consent prior to performing study procedures.
Patients between the age of 45 to 65 years, male or female.
Females must be non-pregnant / non-lactating and practicing adequate birth control measures if not menopausal.

Exclusion Criteria

Patient who are unable to consume solid and liquid orals.
Having active infection 3.
Very high level of creatinine (>4 mg/dl).
Hypersensitivity to test product.
Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To monitor for any changes in any of the Laboratory parameters pre	and post study.

Locations (1): East Coast Hospital
🇮🇳
Pondicherry, PONDICHERRY, India
East Coast Hospital
🇮🇳Pondicherry, PONDICHERRY, India
Dr Venkatram Murugesan
Principal investigator
9042846842
drvenkatram@gmail.com