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临床试验/NCT02681939
NCT02681939已完成2 期

Effect of Supplementation of Tulsi (Ocimum Sanctum Linn.) on Metabolic Parameters and Liver Enzymes in Young Overweight and Obese Subjects

All India Institute of Medical Sciences, Bhubaneswar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Serum lipid profile

研究概览

简要总结

This is a study to investigate the effect of Tulsi (Ocimum sanctum Linn.) on metabolic and biochemical parameters in young overweight and obese subjects. Thirty overweight/obese volunteers will be divided into two groups. The first group will receive no intervention. The second group will be supplemented with one capsule of Tulsi orally every morning and evening in empty stomach for 60 days. The metabolic parameters and liver enzymes will be evaluated before and after the intervention.

详细描述

This is a randomized, parallel group, open label pilot study to investigate the effect of Tulsi (Ocimum sanctum Linn.) on metabolic and biochemical parameters in young overweight and obese subjects. Thirty overweight/obese volunteers will be divided into two groups. The first group will receive no intervention. The second group will be supplemented with one capsule of Tulsi orally every morning and evening in empty stomach for 60 days. The metabolic parameters and liver enzymes will be evaluated before and after the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
17 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Overweight/obese volunteers of both genders from age 17 to 30 years

排除标准

  • Addiction to tobacco and/or alcohol.
  • Not on drugs like fluoroquinolones, anticonvulsants, antihypertensives, corticosteroids, hormonal contraceptives, hypolipidemic agents, anti psychotics, protease inhibitors and isotretinoin.
  • Not suffering from liver disease, malabsorption, nephrotic syndrome, thyroid disorder, allergy or any other chronic disease.

研究组 & 干预措施

Tulsi

Experimental

One capsule of Tulsi (Ocimum sanctum) orally, every morning and evening in empty stomach for 60 days regularly.

干预措施: Tulsi(Ocimum sanctum Linn.) capsules (Drug)

结局指标

主要结局

Serum lipid profile

时间窗: 60 days

次要结局

  • Fasting plasma insulin(60 days)
  • Fasting plasma glucose(60 days)
  • Serum liver enzymes(60 days)
  • Insulin resistance(60 days)
  • Body mass index(60 days)

研究者

发起方
All India Institute of Medical Sciences, Bhubaneswar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sushil Chandra Mahapatra

Professor and Head, Department of Physiology, All India Institute of Medical Sciences, Bhubaneswar

All India Institute of Medical Sciences, Bhubaneswar

研究点 (1)

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