A clinical study to assess the improvement of bone mass and safety of the test product

Not Applicable

• Registration Number: CTRI/2020/03/023713
• Lead Sponsor: ITC Life Sciences and Technology Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Bone mass, Bone Resorption and bone formation markersTimepoint: Day 0, Day 90, Day 180

Secondary Outcome Measures

Name	Time	Method
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