Health Condition 1: M859- Disorder of bone density and structure, unspecified
Conditions
Interventions
None listed
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Provision of signed and dated informed consent prior to any study-specific procedures. • Male & Female subjects between 18 to 80 years of age willing to participate in study & follow study procedures. • Subjects with Reported Intolerance to oral calcium supplementation like constipation/ diarrhoea/ abdominal pain or cramping/nausea based on history. • Confirmed osteoporosis/ osteopenia cases between this age group for either natural or drug induced. • 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. • Non pregnant & non lactating females • Parent/ Guardian of subject ready to provide written informed consent
Exclusion criteria
Exclusion criteria: • Participants who in Investigatorâ??s opinion will not be able to follow study related procedures. • Planning to get pregnant in near future. • Pregnancy • Cardiac failure of Grade II or more â?? (Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity as per NYHA • Hepatic or renal failure â?? basis Liver or Renal Function Tests • X-ray suggestive of Bone tumours • Known history of Endocrine disorders: Hyperthyroidism, hypogonadism, or Cushingâ??s Syndrome • Congenital disorders: Dysosteogenesis, Marfanâ??s syndrome. • Prescence of any significant medical condition: Diabetes, Hypertension, or malignancy • Chronic drug intake, particularly corticosteroids, methotrexate and heparin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in serum calcium levels from baseline to end of study. 2.Change in Clinical symptoms of calcium deficiency like pain in back, bone, fatigue, numbness in finger. 3.Gastro-intestinal tolerability like acidity, abdominal flatulence, constipation, abdominal fullness 4.Changes in hypertensionTimepoint: Pre and Post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: pre and post treatment | — |
Countries
India
Contacts
Public ContactDr Baidyanath Mishra
Mallikatta Neuro Centre
Outcome results
None listed