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Efficacy of Me-Cal in osteoporosis patients as compared to standard calcium supplement

A randomised, double blinded, comparative study to investigate the effectiveness & safety of Me-Cal in osteoporosis patients as compared to standard calcium supplement containing calcitrol, calcium and zinc.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011309
Enrollment
40
Registered
2018-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- OSTEOPOROSIS

Interventions

Intervention1: Me-Cal-Ayurvedic Formulation: Dose:Oral BD, one Capsule in the morning & one capsule in the evening. Duration:12 Weeks Control Intervention1: Standard Calcium Supplement containing Ca

Sponsors

SG PHYTO PHARMA PVT LTD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients complaining of classical symptoms of joint pain, pain in the bones etc. which will be confirmed later by the BMD-test with BMD score below -1. 2. Patient agrees not to use any other calcium supplement for osteoporosis other than what is provided by the study. 3. Patient agrees to written informed consent. 4. Patient willing to participate in the study for 12 weeks. 5. Patient who has not participated in any clinical study in last 30 days.

Exclusion criteria

Exclusion criteria: 1.Planning to conceive, pregnant and lactating mothers. 2. Patient under osteoporosis treatment. 3. Patients suffering from heart disease. 4. Patients with severe renal impairment. 5. Patient with known metabolic bone disease such as osteogenesis imperfecta, or currently healing fractures of lumbar spine, hips or femurs. 6. Patient on current treatment with steroids or chemotherapy. 7. History of malignancy 8. History of hypersensitivity to any of the investigational drugs. 9. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent 10. Any medical condition, where the investigator feels participation in the study could be detrimental to the subjects overall well-being.

Design outcomes

Primary

MeasureTime frame
Percent change in bone mineral density (BMD) due to Me-Cal administration from baseline to last visit of the patient. Percent change in BMD on treatment with Me-Cal as compared to Calcitriol + Calcium Carbonate + Zinc supplementation.Timepoint: BASELINE AND LAST VISIT—

Secondary

MeasureTime frame
The effect of Me-Cal on hematological parameters (Hb, TLC, DLC) from baseline to the last visit. The effect of Me-Cal on lipid profile (TC, LDL-C, HDL-C, Triglyceride, VLDL-C) from baseline to last visit. The effect of Me-Cal on liver function test (LFT) parameters (ALT, AST, ALP) from baseline to last visit. The effect of Me-Cal on renal function test (RFT) parameters (BUN, Creatinine) from baseline to last visit.Timepoint: BASELINE AND LAST VISIT—

Countries

India

Contacts

Public ContactDr Rajesh Sehgal

Pharma Instinct

director@pharmainstinct.com9855423608

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026