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临床试验/CTRI/2024/04/066120
CTRI/2024/04/066120尚未招募2/3 期

Safety and Efficacy of Monodiet Fasting Using Grape Juice in Patients with Non Communicable Diseases An observational study

Dr Gulab Tewani1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2024年5月6日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
43
试验地点
1
主要终点
Anthropometric measurements, Body fat analysis, CBC, LFT, Electrolyte levels, FBS, Lipid profile, Serum protein, Urea and Creatinine, Calorie intake, WHO well being questionnaire, Resilience questionnaire, Patient satisfaction score

研究概览

简要总结

This interventional study aims to investigate the impact of 5 days prolonged medically supervised monodiet grape juice fast regimen on Anthropometric measurements, Body fat analysis, CBC, LFT, Electrolyte levels, FBS, Lipid profile, Serum protein, Urea and Creatinine and various clinical variables associated with mono diet grape juice fast among non-communicable diseases. The primary objective is to assess changes in the Anthropometric measurements, Body fat analysis, CBC, LFT, Electrolyte levels, FBS, Lipid profile, Serum protein, Urea and Creatinine, Calorie intake, WHO well being questionnaire, Resilience questionnaire, Patient satisfaction score. The study will be conducted over 2 months, with a simple size of 43 non-communicable disease patients. The intervention involves preparatory fasting for 2 days , followed by 5 days monodiet grape juice fast and followed by refeeding with herbal drink, fruit diet, semi-solid and solid diet.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Adults aged 18-75 years with a diagnosed non-communicable disease (e.g., type 2 diabetes, hypertension, cardiovascular disease).
  • Ability to give informed consent.
  • Not currently pregnant or breastfeeding.

排除标准

  • Participants with severe comorbid conditions requiring immediate medical intervention.
  • Participants who have history of allergic reactions to grapes or grape products.
  • Participants who are currently undergoing another dietary intervention study.

结局指标

主要结局

Anthropometric measurements, Body fat analysis, CBC, LFT, Electrolyte levels, FBS, Lipid profile, Serum protein, Urea and Creatinine, Calorie intake, WHO well being questionnaire, Resilience questionnaire, Patient satisfaction score

时间窗: Anthropometric measurements - At day 1 and day 10 during intervention | Body fat analysis - At day 1 and day 10 during intervention | CBC - At day 1 and day 10 during intervention | LFT - At day 1 and day 10 during intervention | Electrolyte levels -At day 1 and day 10 during intervention | FBS - At day 1 and day 10 during intervention | Lipid profile - At day 1 and day 10 during intervention | Serum protein - At day 1 and day 10 during intervention

次要结局

  • WHO well being questionnaire, Resilience questionnaire, Patient satisfaction score(At day 1 and day 10 during intervention)

研究者

发起方
Dr Gulab Tewani
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Gulab Rai Tewani

Sant Hirdaram Medical College of Naturopathy and Yogic Sciences

研究点 (1)

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