Health Condition 1: null- Menopausal Syndrome (Osteoporosis)
Conditions
Interventions
Intervention1: LactoSpore: Orally once daily for 180 days
Control Intervention1: Vitamin D3, Calcium tablets: Orally once daily for 180 days
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ambulatory postmenopausal Indian women, less than or equal to 45 to more than or equal to 80 years of age at enrolment. 2.If a patients menopausal status at screening is in question, by history or due to the patient having a hysterectomy without oophorectomy,a follicle-stimulating hormone level to be obtained. Patients with an FSH more than 40 will satisfy the definition of postmenopausal status. 3.Post menopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to screening. 4.Women who are 45to 54 years of age with the following bone mineral density : BMD T-score more than or eqaual to 3 at the lumbar spine, total hip or femoral neck are evaluable by DEXA. 5.Women 55 or more years of age with the following BMD: BMD T-score more than or equal to 2.5 at the lumbar spine, total hip or femoral neck are evaluable by DEXA. 6.Willing to come for regular follow -up visits 7.Able to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects with a BMD T-score less than or equal to -4.0 at the lumbar spine, total hip, or femoral neck. 2. History of hip fracture. 3. Bone disease other than osteoporosis/ or evidence of any other clinically significant disorder, condition/ or disease or significant laboratory abnormalities. 4. History of hypersensitivity to the investigational product or its constituents. 5. Prior external beam or implant radiation therapy involving the skeleton. 6. Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. 7. Suspected or confirmed poor compliance, according to investigators judgment, in completing the trial and follow up. 8. Any other condition which the principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Percent change in DEXA Bone Mineral Density 2 Change in Myeloperoxidase 3 Change in blood calcium and bone specific alkaline phosphatase 4 Quality of Life QuestionnaireTimepoint: 1 DEXA-Day0 and Day180 2 Myeloperoxidase-Day0,90 and 180 3 Blood calcium and bone specific alkaline phosphatase-Day0,90 and 180 4 Quality of Life Questionnaire-Day0,60,120 and 180. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and rate of adverse eventsTimepoint: Incidence and rate of adverse events-Day0,30,60,90,120,150 and Day 180 | — |
Countries
India
Contacts
Public ContactMrSubramanina Jagadeesan
ClinWorld Private Limited
Outcome results
None listed