A Controlled Open Label Single Arm Proof Of Concept Study ToEvaluate The Safety Of De-NaPKC Foxtail Millet Powder WithLow Salts In Stage 3 Chronic Kidney Disease In Indian Population.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- 1)Each patient will be monitored for any adverse drug reaction.
研究概览
简要总结
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
-
Adverse drug reaction
-
Safety Parameters
-
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •Patient who are unable to consume solid and liquid orals.
- •Having active infection
- •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.
结局指标
主要结局
1)Each patient will be monitored for any adverse drug reaction.
时间窗: Day 0, Day 7, Day 15
Gastritis, ability to consume 350 ml, skin reaction, able to
时间窗: Day 0, Day 7, Day 15
pass stool comfortably, any event of hypoglycemic in
时间窗: Day 0, Day 7, Day 15
Other Safety parameters includes monitoring for any change
时间窗: Day 0, Day 7, Day 15
in the blood parameters.
时间窗: Day 0, Day 7, Day 15
2) Other parameters monitored include; Nausea, Vomiting,
时间窗: Day 0, Day 7, Day 15
diabetic patient, palpitation, hypertensive or hypotensive
时间窗: Day 0, Day 7, Day 15
episodes and weight gain or loss.
时间窗: Day 0, Day 7, Day 15
次要结局
- To monitor for any changes in any of the Laboratory parameters pre(and post study.)