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A Clinical Trial Study to Evaluate the Safety & Efficacy of Herbal Extract on Bone Health in Healthy Adult Volunteers.

A Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate The Safety & Efficacy of Herbal Extract on Bone Health in Healthy Adult Volunteers.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/06/006978
Enrollment
120
Registered
2016-06-01
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

None listed

Interventions

Intervention1: Herbal extract: Oral, Twice daily Intervention2: group 1 -Intervention BH-1(250 mg of test ingredient): group 1 -Intervention(250 mg of test ingredient) oral, one capsule twice per day

Sponsors

ITC Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male and female Age Male 18 to 60 Female 18 to 45 and female 46 to 65 Subjects able to provide informed consent with audio video visuals

Exclusion criteria

Exclusion criteria: History of HIV positive patients History of hepatitis, Pancreatitis, lactic acidosis or hepatomegaly with steatosis. History of motor weakness or Peripheral sensory neuropathy Present history of mental diseases Patients currently on treatment with estrogenic drugs, calcium building drugs, corticosteroids. Patients who had taken antiandrogenic drugs during the previous 3 months were not enrolled in the study Patients consuming herbal supplements (DHEA) Pregnant or lactating woman Previous Participation in a Clinical trial within 6 months

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of Herbal Extract on bone health in Healthy adult volunteersTimepoint: Screening(day 0) ,visit 2 ( day 135), visit 3 ( day 270)—

Secondary

MeasureTime frame
To assess the safety of Herbal Extract on bone health in Healthy adult volunteersTimepoint: Screenig (day0), visit 2( day 135), visit 3 (day 270)—

Countries

India

Contacts

Public ContactDr Harisha S

ICBio Clinical Research Pvt. Ltd.

harish@icbiocro.com9900111997

Outcome results

None listed

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