Pharmaco-therapeutic Evaluation of Balya Action of Madhuka Pushpa on Sportspersons and Healthy Volunteers
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The expected primary end point is that Madhuka (Madhuca indica J.F. Gmel) is effective in Enhancement of Stamina and Endurance in Sportspersons and healthy volunteers (Balya) which will be assessed through subjective and objective parameters and the Five point investigators global assessment scale (very much improved, much improved, improved, mildly improved, worse) will be used for efficacy.
研究概览
简要总结
Healthy living with full strength and vigor is a dream of every individual living this earth. Hence, he always revised and defined the concept of complete health to suit the needs of the time. But the definition of Acharya Sushruta defined in Sutra Sthana 15th chapter 41st quotation, that has considered proper functioning of every component that have their own influence in maintaining the quality of life or living. Ayurveda being one of the leading systems of Alternative Medicines cannot be away from new inventions to enter into new fields. The sports Medicine is one of such fields where it has to show its power of cure and power of preventing diseases.
Ayureda, the science of healing has stood the tides of time and is now again the popularity which it had lost in the middle for many reasons. The sources of medicines used in Ayurveda are usually from the natural ones which are either animal, mineral and the most important one is the plants.
Among the three sources the plant origin drugs form the majority of drugs mentioned in the materia medica. Today, the knowledge of drugs with respect to identification, formulation and use has gone far beyond those mentioned in the classical texts. But still there are many instances where there is necessary to reprove the claims that are done in the classical literatures. Hence, research for the Balya activity of drugs among the sportspersons and healthy volunteers to increase their stamina and endurance and to establish the claims of classical literature is of utmost importance.
Balya Karma as described in Ayurveda is a complex one, which unfolds many activities of the balya drugs on deep analysis. Hence, a comprehensive protocol involving many testing mechanisms is necessary for the evaluation and ascertainment of such an activity of Ayurveda.
Ayurveda holds the concept of Brimhana and Balya for overall growth of the body and potentiating the strength, energy and endurance in the healthy individuals. Hence, the drugs that are useful in enhancing the physical strength and sports performance of sportspersons and healthy volunteers are to be looked for. In other words that which is favourable and lead to the increase of ‘Bala’ is considered as ‘Balya’. Hence it is quite necessary to understand the concept of Bala as per Ayurveda.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Physically and mentally healthy sportspersons and healthy volunteers who fit in the Par-Q Test (Physical Activity Readiness Questionnaire) Healthy sportspersons and healthy volunteers irrespective of sex, religion, education, occupation etc and aged between 18 or 30 years will be selected for the study.
- •Sportspersons involved in outdoor games only, specifically athletics or swimming.
排除标准
- •The sportspersons and healthy volunteers who are taking treatment for any major disorders or with physical disability.
- •Subjects on systemic or oral steroids or with alcohol or drug dependency.
- •Subjects who have participated in any clinical trial in past 6 months.
结局指标
主要结局
The expected primary end point is that Madhuka (Madhuca indica J.F. Gmel) is effective in Enhancement of Stamina and Endurance in Sportspersons and healthy volunteers (Balya) which will be assessed through subjective and objective parameters and the Five point investigators global assessment scale (very much improved, much improved, improved, mildly improved, worse) will be used for efficacy.
时间窗: 3 months
次要结局
- The expected secondary end point is the assessment of pharmacognostical and phytochemical properties of the drug which will be done through GMP certified labs.(3 months)