Effect of Myostaal SB Tablets in Participants Suffering with Osteopenia

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Participant of either sex in the age group of 40-75 years (both years inclusive).

2.Participantâ??s suffering from Osteopenia with BMD T- score between (-1 to -2.5)

3.Participantâ??s with a history of fractures that may have occurred with a minor injury or fall.

4.Participantâ??s willing to give written informed consent.

5.Participantâ??s willing to follow up.

Exclusion Criteria

1.Participantâ??s consuming any drug known to affect bone metabolism e.g. SERMs, bisphosphonates, calcitonin, Vit.D (more than 60,000 units), methotrexate, anti-epileptic drugs, loop diuretics, corticosteroids (more than 5mg/day of prednisolone or equivalent) etc for more than 3 months.

2.Participantâ??s with Serum Ca2+ level is either < 2.2 or > 2.6 mmol/L ( < 9 or >10.5 mg/dL)

3.Participant suffering from Osteomalacia, Tumor, Osteonecrosis, osteomyelitis or any other bone-softening metabolic disorders.

4.Participantâ??s suffering from congenital disorders (Dysosteogenesis and Marfanâ??s Syndrome)

5.Participantâ??s with documented history of Leukemia, Lymphoma, Metastases (bony and other), Pathologic fractures secondary to bone metastases from cancer, Pediatric osteogenesis imperfecta or Renal osteodystrophy, Malabsorption syndrome

6.Participantâ??s with documented history of endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushingâ??s syndrome)

7.Participantâ??s with history of any Organ transplantation

8.Participantâ??s who are immobilized since > 6 weeks

9.Participantâ??s who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, heart failure Stroke or Severe Arrhythmia in the last 6 months.

10.Participantâ??s with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.

11.Participantâ??s who may require treatment of oral and/or injectable steroids or surgical intervention during the course of study duration.

12.Participantâ??s with history of clinically-active renal, hepatic or peptic ulcer disease

13.History of life threatening cardiovascular and /or neurological event in the past one year.

14.Participantâ??s having any severe active infectious disease requiring hospitalization.

15.Participantâ??s who has undergone or who is planning to undergo surgery in next 3 months will be excluded from the study

16.Participantâ??s with abnormal Hb/CBC values, 10% beyond the normal range will lead to exclusion of the participant from the study.

17.Participantâ??s with hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as Sr. creatinine > 1.2mg/dl).

18.Participantâ??s with uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients)

19.Participantâ??s with history of alcohol or drug abuse.

20.Pregnant and lactating women.

21.Participantâ??s receiving any other treatment for Osteopenia other than vitamin supplements.

22.Participant who has taken study drug or any herbal medication in the past 4 weeks.

23.Participant with history of severe allergy or anaphylactic reaction.

24.Participant participating in another investigational drug trial in the previous 30 days.

25.Participantâ??s who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness

26.Participant with documented history of positive screening result for hepatitis B and/or Hepatitis C virus.

27.Participant with documented history of HIV or any immune deficient conditions.

28.Any other condition which the P.I. thinks may jeopardize the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate efficacy of Myostaal SB Tablets in Participantâ??s suffering from osteopenia in terms of change in the BMD score before and after interventionTimepoint: â?¢To evaluate efficacy of Myostaal SB Tablets in Participantâ??s suffering from osteopenia in terms of change in the BMD score at baseline and after 6 months at the end of study

Secondary Outcome Measures

Name	Time	Method
1.To evaluate the change in the Ayurvedic symptom scores before and after intervention <br/ ><br>2.To assess the change in the biochemical markers (vitamin D, Alkaline phosphatase level(ALP) PTH (Parathyroid harmone)levels before and after intervention <br/ ><br>3.To assess the safety of tablet Myostaal SB with respect to hematological parameters like Hb, CBC, SGOT, SGPT, BUN, S. Creatinine <br/ ><br>Timepoint: day 0, day 90 and day 180