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Study on Osteoporosis

Not Applicable
Conditions
Health Condition 1: null- Osteoporosis and Osteopenia
Registration Number
CTRI/2017/05/008662
Lead Sponsor
Central Council for Research in Ayurvedic Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Patients of either sex with age above 45years and upto 70 years.

2.B.M.D.T. Score ( -1 to -3) on DEXA Scan

3.Patient willing to participate in the clinical trial

Exclusion Criteria

1.Patients who are consuming corticosteroids (more than 5mg/day of prednisolone or equivalent) for more than 3 months

2.Patients with history of Fragility Fracture.

3.Patients suffering from congenital disorders related to bone (Dysosteogenesis, Marfanâ??s Syndrome, etc.)

4.Patients with (Hypothyroidism and Hyperthyroidism, Hypoparathyroidism and Hyperparathyroidism, Cushingâ??s syndrome)

5.Patients suffering from Osteomalacia.

6.Patients suffering from Malabsorption syndrome

7. Patients who have undergone Organ transplantation

8.Patients who are immobilized since > 6 weeks

9.Patients with history of bone fracture in last 6 months.

10.Patients with evidence of malignancy

11.Pregnancy and lactation

12.Patients who cannot report in person once in 2 weeks in the OPD

13.Patients with poorly controlled Hypertension ( >160/100 mmHg)

14.Patients with poorly controlled Diabetes Mellitus having Hb A1C of >8

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

16.Patients with history of Urolithiasis.

17.Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dl), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.

18.Alcoholics, smokers, and/or drug abusers

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

20.Patients who have completed participation in any other clinical trial during the past six months.

21.Patients on calcium and Vitamin D supplementation

22.Known cases of Pagetâ??s disease of bone.

23.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement in BMDTTimepoint: 84th day
Secondary Outcome Measures
NameTimeMethod
Improvement in clinical parametersTimepoint: 84 days
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