CTRI/2017/05/008662RecruitingNot Applicable
Clinical evaluation of Laksha Guggulu, Muktasukti Bhasma in the management of Osteopeniea/ Osteoporosis
Central Council for Research in Ayurvedic Sciences2 sites in 1 country60 target enrollmentStarted: March 22, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Improvement in BMDT
Study Overview
Brief Summary
For the scientific validation of classical Ayurvedicformulations a multi centric clinical trial has been initiated for themanagement of Asthisaushirya (Ostoporosis/Osteopenia) as an activity underIntra Mural Clinical Research Programme. Ayurvedic medicines Laksha guggulu,Muktasukthi Bhasma selected for the study. Treatment will be given for 12weeks, Sample size is 60. Duration of the treatment is 12 weeks. Total studyperiod is 2 years.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 45.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
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, Marfan’s Syndrome, etc.) 4.Patients with (Hypothyroidism and Hyperthyroidism, Hypoparathyroidism and Hyperparathyroidism, Cushing‘s syndrome) 5.Patients suffering from Osteomalacia.
- •6.Patients suffering from Malabsorption syndrome
- •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 Paget’s disease of bone.
- •23.Any other condition which the Investigator thinks may jeopardize the study.
Outcomes
Primary Outcomes
Improvement in BMDT
Time Frame: 84th day
Secondary Outcomes
- Improvement in clinical parameters(84 days)
Investigators
Study Sites (2)
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