CTRI/2019/06/019792CompletedPhase 2/3
A randomized controlled, single blind clinical trial for safety and efficacy of grassroots leads in the management of Osteopenia / Osteoporosis among postmenopausal women
National innovation foundation1 site in 1 country360 target enrollmentStarted: January 7, 2019Last updated:
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Completed
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- To compare the safety and efficacy of Grassroots leads with Ayurvedic drug (Lakshadi Guggulu and Praval Pishti) and Allopathic drug(Shalcal) in subject with postmenopausal osteoporosis.
Study Overview
Brief Summary
This randomized multi arm controlled, single blind clinical trial was done for safety and efficacy of two grassroots leads in the management of osteopenia/ osteoporosis among postmenopausal women. Two grassroots leads in two different formulation and in two different doses were compared against standard Ayurvedic drug and standard allopathic drug.Each group was given one year of medication.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 70.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Postmenopausal women, defined as no menstruation for the last 12 months.
- •B.M.D.T. Score -1 to -3.5 at hip, spine and forearm (worst score at any of the three sites to be considered).
Exclusion Criteria
- •score above -1 and less than -3.5
- •All women who are consuming any drug which is known to affect bone metabolism in doses for e.g. SERMs, bisphophonates, calcitonin, Vit.
- •D more than 60,000 units and corticosteroids more than 5mg/day for more than 3 months, methotrexate, anticonvulsants and diuretics.
- •Patients suffering from congenital disorders (Dysosteogenesis and Marfan.s Syndrome)
- •Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushing.s syndrome)
- •Patients with evidence of malignancy
- •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Epilepsy)
- •Patients suffering from chronic hepatic disorder, renal failure or cardiac dysfunction.
- •Patient suffering from uncontrolled DM-2 or uncontrolled hypertension.
- •Patients suffering from Osteomalacia.
- •Patients suffering from Malabsorption syndrome
- •Patients undergone Organ transplantation or on immunosuppressive therapy
- •Prolonged immobilization
- •Patients whose Serum Ca++ level < 2.2 or > 2.6 mmol/L (< 9 or >10.5 mg/dL)
- •History of renal stones
- •Long bone fracture in last 6 months.
- •Patient not ready to give an informed consent
- •Subjects who has participated in any other clinical study in last 30 days.
- •Patients with clinical evidence of active and chronic illness as rheumatoid arthritis, gout,SLE, Psoriatic arthritis.
Outcomes
Primary Outcomes
To compare the safety and efficacy of Grassroots leads with Ayurvedic drug (Lakshadi Guggulu and Praval Pishti) and Allopathic drug(Shalcal) in subject with postmenopausal osteoporosis.
Time Frame: 1 year
Secondary Outcomes
- To assess the biomarker response for bone formation of study drugs in postmenopausal osteoporosis
- Mean changes in quality of life among women suffering from postmenopausal osteoporosis(1 year)
Investigators
Study Sites (1)
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