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临床试验/CTRI/2024/08/072799
CTRI/2024/08/072799尚未招募2 期

Efficacy of Black rice ( ORZYA SATIVA L INDICA) in Obesity : Open lable double arm exploratory randomized controlled trial.

Bharati Vidyapeeth Deemed to be university1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月5日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
The primary outcome will be the 10% body weight reduction from baseline

研究概览

简要总结

The last few decades have seen a marked rise in obesity rates worldwide, despite numerous efforts at prevention and treatment. This has resulted in a substantial financial and health burden. Imbalanced nutritional value and uncontrolled eating lead to the development of obesity and poor self-esteem. Food grains such as brown rice have recently drawn the attention of many researchers away from synthetic treatments in favor of safe, natural solutions for obesity since they are readily available and reasonably priced. However, no such studies have been reported on the indigenous variety of black rice, ‘Krishnavrihi (Oryza sativa L indica). According to Sushruta (Sushruta saṃhita Sutrasthana 46/14), among the vrihi /rice the black variety, which is called Ká¹›iá¹£hṇavrihi, is the best. Krishnavrihi is kashaya in anurasa, reduces all three doshas, increases Agni, and enhances strength and virility. (Bhojana-kutuhala, Sri Raghunatha Suri.).It has has kleda meda vishoshan property.

Black rice (BR) has high nutritional value due to the presence of 18 amino acids, carotene, vitamin E, iron, zinc, and copper and high anthocyanin content (327.60 mg/100g). Epidemiological evidence reported that anthocyanins possess not only high antioxidant and anti-inflammatory activities but also improve metabolic complications associated with obesity. Black rice contains cyanidin-3-o-glucoside (C3G), which is known to act by directly interacting with PPARα to increase hepatic fatty acid oxidation and reduce fatty acid synthesis. These effects lead to reduced plasma and hepatic TG concentrations, with increased ketogenesis, improved NAFLD, glucose and insulin tolerance, and adiposity. Studies have demonstrated that black rice extract (BRE) (Heukmi) inhibited adipogenic differentiation in C3H10T1/2 multipotent stem cells.

Given the small number of studies on black rice originating from northeast India, the current study would therefore provide scientific proof for its health benefits.

The study is a dietary intervention trial; an open-label, double-arm exploratory clinical study of black rice to find out efficacy in obesity will be carried out. Obese patients visiting BVDU’s College of Ayurveda and Hospital will be recruited in the trial by following standard protocol. The study site will be the Dept. of Kayachikitsa of B.V.D.U.C.O.A. and Hospital, Pune.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Obese individuals showing symptoms of obesity, having BMI between ≥25.0 kg/m2 and ≤ 34.9 kg/m2), without or with controlled co-morbid conditions such as dyslipidemia, hypertension, and type 2 diabetes mellitus.

排除标准

  • Individuals with known endocrinological disorders such as hyper/hypothyroidism, Poly Cystic Ovarian Syndrome (PCOS) Major depressive or other severe psychiatric disorders Drug-induced obesity Individuals taking herbal drugs or nutritional supplements/multivitamin supplements within the past 30 days for weight loss Pregnant and lactating females Individuals taking Metformin or Insulin for Diabetes mellitus.

结局指标

主要结局

The primary outcome will be the 10% body weight reduction from baseline

时间窗: 90 days

次要结局

  • Improvement in body circumference, percentage of body fat, visceral fat

研究者

发起方
Bharati Vidyapeeth Deemed to be university
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Madhavi Mahajan

Bharati Vidyapeeth college of ayurved and hospital pune

研究点 (1)

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