Study of Ayurvedic drug Calciactiv for the treatment of bone weakness

Phase 2

Completed

• Conditions: Health Condition 1: M810- Age-related osteoporosis without current pathological fractureHealth Condition 2: null- Osteopenia, Osteoporosis, Decreased Bone Density

• Registration Number: CTRI/2017/08/009259
• Lead Sponsor: Siddhayu Ayurvedic Research Foundation Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-06-05
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Adult patients (age 18 â?? 65 years) of either sex

2.Clinical symptoms of osteopenia and osteoporosis (bone pain, joint pain, frequent fractures etc.)

Exclusion Criteria

1.Patients not willing to participate in the study

2.Patients with complicating comorbid conditions like cardiac disorders, uncontrolled diabetes, renal impairment, hepatic impairment etc.

3.Patients with severe osteoporosis due to chemotherapy or as a complication of other concurrent treatments.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of efficacy of Calciactiv using improvement in clinical symptoms of osteopenia and osteoporosis and Bone density testing using peripheral Dual energy x-ray absorptiometry (DXA).Timepoint: 0 days, 15 days, 30 days

Secondary Outcome Measures

Name	Time	Method
Evaluation of safety and tolerability of Calciactiv by recording and assessing causality of adverse events during the study.Timepoint: 15 days, 30 days