A randomized, double blind, clinical study to evaluate the efficacy of LactoSporeÂ® (Bacillus coagulans MTCC5856) as an adjuvant therapy for Menopausal Syndrome (Osteoporosis).

Sami Labs Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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.

发起方

Sami Labs Limited