An open label, randomized, parallel, two arm [Resins] prospective clinical study of Herbo-mineral Ayurvedic formulation to evaluate the efficacy focusing on their impact on physical and mental health in healthy volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Improvement in strength, power and energy [Balya] 2. Improvement in bone and muscle strength [Balya] (Bone profile basic non fasting examination – ALP, Calcium, serum phosphorus, Vitamin D, Zinc and Parathyroid).
研究概览
简要总结
Objective is to evaluate efficacy and safety of Herbo-mineral Ayurvedic formulations focusing on their impact on physical and mental health. Inclusion criteria: 1. Male participants aged between 18-60 years having BMI less than 35 kg/m2. 2. Resting blood pressure averaging less than 140 by 90 mm/Hg. 3. Not on any medication for cardiovascular and metabolic disorders. 4) Willing to provide consent and come for follow-up visits. Exclusion criteria: 1. Participants with any acute illness require immediate medical care. 2. Participants with any chronic medical condition. 3. Any other condition which proves participant unfit for the study participation. 4. Any known cardiovascular or metabolic disease. 5. Participants who are taking any other related supplementation. Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or preclude the successful completion of the study. Primary outcomes: improvement in strength, stamina and energy.
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 60.00 Year(s)(—)
- 性别
- Male
入选标准
- •Male participants aged between 18-60 years having BMI less than 35 kg/m
- •Resting blood pressure averaging less than 140 by 90 mm/Hg.
- •Not on any medication for cardiovascular and metabolic disorders.
- •Willing to provide consent and come for follow-up visits.
排除标准
- •Participants with any acute illness require immediate medical care.
- •Participants with any chronic medical condition.
- •Any other condition which proves participant unfit for the study participation.
- •Any known cardiovascular or metabolic disease.
- •Participants who are taking any other related supplementation.
- •Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or preclude the successful completion of the study.
结局指标
主要结局
1. Improvement in strength, power and energy [Balya] 2. Improvement in bone and muscle strength [Balya] (Bone profile basic non fasting examination – ALP, Calcium, serum phosphorus, Vitamin D, Zinc and Parathyroid).
时间窗: week 1 and week 12
3. Improvement in recovery from weakness [Rasayana] 4. Improvement in performance
时间窗: week 1 and week 12
5. Improvement in mental health [Medya] (stress, memory and cognition).
时间窗: week 1 and week 12
次要结局
- 1. Change in serum testosterone levels(2. Safety and tolerability)
研究者
Dr Abdul Kadhar
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE AND RESEARCH CENTRE
