None listed
Conditions
Interventions
Intervention1: Test Product 1: Oral Administration of 500 mg capsule containing 125mg herbal extract once a day for 6 months
Intervention2: Test Product 2: Oral Administration of 500mg capsule cont
Sponsors
ITC Life Sciences and Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with low bone mass (BMD, T- score of -1 to -2.5 SD) 2. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form
Exclusion criteria
Exclusion criteria: 1. History of any illness affecting bone metabolism like renal failure, hepatic failure, active malignancy, hyperthyroidism or hyper parathyroidism 2. Pregnant or lactating women. 3. Female patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study treatment and for 4 weeks after the end of treatment. 4. Subjects with Alkaline phosphatase more than twice the upper limit of normal, Liver disease (SGOT or SGPT more than twice the upper limit of normal),Kidney disease (creatinine >2.0 mg/dL) Hypercalcemia (calcium >10.5 mg/dL) 5. Uncontrolled chronic disorders that could affect bone metabolism (liver disease, alcoholism, primary hyperparathyroidism, or malignancy) 6. Pharmacotherapy for osteoporosis (except calcium or vitamin D) in the previous 3 months 7. Injection of an agent for osteoporosis in the previous 6 months 8. Systemic administration of an agent that may affect calcium metabolism in bone, such as a systemic corticosteroid or diuretic, for more than 6 months (subjects who have not received forbidden drugs except contraceptive injections within the previous 3 months before screening may be eligible to participate) 9. Metabolic bone diseases other than osteoporosis 10. A mental disorder likely to affect compliance with the requirements of the trial 11. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 12. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Bone mass, Bone Resorption and bone formation markersTimepoint: Day 0, Day 90, Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| change in Joint Health and Inflammatory markersTimepoint: Day 0, Day 90, Day 180;Changes in Questionnaire based AssessmentsTimepoint: Day 0, Day 90, Day 180;Changes in Serum levels of calcium, phosphorus and vitamin DTimepoint: Day 0, Day 90, Day 180 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed