Evaluation of Safety and Efficacy of Innovative Natural Calcium Formulation for Bone & Muscle Health
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Change in serum calcium levels from baseline to end of study.
研究概览
简要总结
Current study is a clinical study of innovative ayurceutical formulation for bone and muscle health. Study will be conducted under supervision of Allopathic Doctor as investigator in subjects between 18 to 60 years of age and who will be followed up at monthly intervals. results of the study will be assessed basis relieving of symptoms and change in serum calcium level, improvement in quality of life from baseline to end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Provision of signed and dated informed consent prior to any study-specific procedures.
- •â€¢ Male & Female subjects between 18 to 80 years of age willing to participate in study & follow study procedures.
- •â€¢ Subjects with Reported Intolerance to oral calcium supplementation like constipation/ diarrhoea/ abdominal pain or cramping/nausea based on history.
- •â€¢ Confirmed osteoporosis/ osteopenia cases between this age group for either natural or drug induced.
- •â€¢ Peri or post-menopausal women with or without oestrogen therapy • Neurological ailments with co-prescription of oral calcium • Diabetic patients with OHD or insulin need of additional calcium intake.
- •â€¢ Non pregnant & non lactating females • Parent/ Guardian of subject ready to provide written informed consent.
排除标准
- •â€¢ Participants who in Investigator’s opinion will not be able to follow study related procedures.
- •â€¢ Planning to get pregnant in near future.
- •â€¢ Pregnancy • Cardiac failure of Grade II or more – (Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity as per NYHA • Hepatic or renal failure – basis Liver or Renal Function Tests • X-ray suggestive of Bone tumours • Known history of Endocrine disorders: Hyperthyroidism, hypogonadism, or Cushing’s Syndrome • Congenital disorders: Dysosteogenesis, Marfan’s syndrome.
- •â€¢ Prescence of any significant medical condition: Diabetes, Hypertension, or malignancy • Chronic drug intake, particularly corticosteroids, methotrexate and heparin.
结局指标
主要结局
1. Change in serum calcium levels from baseline to end of study.
时间窗: Pre and Post treatment
2. Change in Clinical symptoms of calcium deficiency like pain in back, bone, fatigue, numbness in finger.
时间窗: Pre and Post treatment
3. Gastro-intestinal tolerability like acidity, abdominal flatulence, constipation, abdominal fullness
时间窗: Pre and Post treatment
4. Changes in hypertension
时间窗: Pre and Post treatment
次要结局
- 1. Product Acceptability, Palatability & Tolerability(2. Impact and positive impact in changes in Psychosomatic behaviours those visible in lower calcium in body like tolerability to stress, cognition, memory, psycho-stress)
研究者
Dr Shankara Nallikunja
Mallikatta Neuro Centre