A clinical study to see the effect of some Ayurvedic formulations in the patients of Bone loss.

Phase 2

• Conditions: Health Condition 1: null- Osteopenia/Osteoporosis

• Registration Number: CTRI/2012/07/002775
• Lead Sponsor: Department of AYUSH Ministry of Health Family Welfare Government of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1 Patients of either sex between 45 to 65 years of age.

2 B.M.D.T-. Score of < -1

3 Willing and able to participate for 16 weeks

Exclusion Criteria

1. Patients who are consuming any drug which is known to affect bone metabolism for e.g. SERMs, bisphophonates, calcitonin, Vit.D (more than 60,000 units) and corticosteroids (more than 5mg/day of prednisolone or equivalent) for more than 3 months, methotrexate, anti- convulsants, diuretics, etc

2. Patients with history of Fragility Fracture.

3. Patients suffering from congenital disorders (Dysosteogenesis and Marfanâ??s Syndrome)

4. Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushingâ??s syndrome)

5. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)

6. Patients suffering from Osteomalacia.

7. Patients whose Serum Ca++ level < 2.2 or > 2.6 mmol/L ( < 9 or >10.5 mg/dL)

8. Patients suffering from Malabsorption syndrome

9. Patients who have undergone Organ transplantation

10. Patients who are immobilized since > 6 weeks

11. Patients with history of Long bone fracture in last 6 months.

12. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

13. Symptomatic patient with clinical evidence of Heart failure.

14. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.

15. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)

16. Alcoholics and/or drug abusers.

17. Patients with evidence of malignancy

18. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)

19. Pregnant or lactating woman.

20. H/o hypersensitivity to any of the trial drugs or their ingredients

21. Patients who have completed participation in any other clinical trial during the past

six (06) months.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified