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临床试验/CTRI/2024/02/062379
CTRI/2024/02/062379已完成2/3 期

A single-blind parallel arm randomized placebo-controlled trial on the effect of Withania somnifera 6C in improving cardiorespiratory endurance in children undergoing athletic training

Sarada Krishna Homoeopathic medical college1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月15日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Improvement of cardiorespiratory endurance and fitness index

研究概览

简要总结

Professional athletes face challenges like exhausting training or intensive competition to push their bodies beyond our imagination. To prevent and recover from mental and physical health problems regular exercise, especially moderate or vigorous-intensity aerobic activity is important but at some instance this intense exercise can actually compromise health. Ashwagandha, otherwise known as Indian ginseng or poison gooseberry, belongs to the Solanaceae family. In addition to its adaptogenic properties, there are multiple medicinal benefits including antitumor, anti-inflammatory, hypoglycemic and antioxidant effects has been studied. The wide structural variety of withanolides might be related to the multiple biological functions that have been described for Ashwagandha: antimicrobial, anti-inflammatory, immunomodulatory, neuroprotective, cytotoxic, and antioxidant, etc. Homoeopathy has shown its effectiveness in many fields but there aren’t much studies in the field of sports. For an athlete the most important part is improving their performance in the competition. But it is not an overnight process behind winning. They take a lot of effort and the main part is improving their stamina. It includes both mental and physical ability to sustain the activity for a long time. Homoeopathy can improve the general health and can also improve the performance of athletes performance.Study will be on subjects of 18 years and below. The sample will be selected through school health programmes and other volunteers from SKHMC. The total samples will be 30. Samples will be stratified based on age and sex. They will be divided into placebo group and medicinal group. Assessments like Height, Weight, exhaustion time, fitness index and VO2 max will be done before starting the study. These parameters will be obtained through Harvard step test and their CBC will also be assessed.  At the initial month they will be given regular exercise on a daily basis. Then for the next 3 months the samples will be divided into 2 groups, one group will be given placebo and the other group will be given Withania somnifera 6C on a random basis. Every subject will be adviced to take a proper diet. At the beginning of the 4th month again the fitness index will be calculated along with VO2max and exhaustion time along with CBC. The result will be obtained using paired t test, Chi-square test and correlation analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • Only children of age group between 12 and 18 years of age Children who are healthy, not under any medications Children interested in regular athletic training.

排除标准

  • Children above 18 years and below 12 years of age Children with any cardiorespiratory illness rheumatic complaints and other systemic illness.

结局指标

主要结局

Improvement of cardiorespiratory endurance and fitness index

时间窗: initial visit and after 3 months

次要结局

  • Improvement in hemoglobin value(initial visit & after three months)

研究者

发起方
Sarada Krishna Homoeopathic medical college
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Abina Augustine

Sarada Krishna Homoeopathic medical college

研究点 (1)

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