None listed
Conditions
Interventions
Intervention1: OsteoCaf TM Capsule: 300 mg capsule, orally twice a day once in the morning after
breakfast and once in the evening after dinner
Control Intervention1: NIL: -
Sponsors
PhytoVeda Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male and female human participants aged between 18 and 65 years (both inclusive) 2.Participants with a BMI between 18.50-30.00 kg/m2 3.Participants in normal physiological health as determined by personal medical history, clinical examination including vital signs and clinically acceptable results of laboratory examinations (including serological tests) 4.Participants having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording 5.Participants having a normal or clinically not significant chest X-ray (PA view) 6.Willingness to adhere to dietary restrictions and avoid other supplements or medications during the study period 7.Participant able to communicate effectively and willing to provide written informed consent 8.Participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee 9.Availability of volunteers for the entire study duration.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to Dalbergia sissoo extract or related product or any component of this intervention 2.Clinically significant medical condition, such as but not limited to cardiovascular, neurological psychiatric, pulmonary, renal, immunological, endocrine, or haematological abnormalities; 3. Evidence of significant clinical abnormalities detected during the screening procedure determined by the investigator; 4.History of any acute/chronic disorders 5.History of chronic medication within the past 6 weeks 6.history of hypersensitivity to any medication 7.History of use of drugs known to affect CNS performance 8.Regular smokers who smoke more than 9 cigarettes daily or have difficulty in abstaining from smoking during the study duration 9.History of drug dependence or chronic alcohol use associated with or without altered hepatic functions, use of any microsomal enzyme modifying drugs within 30 days, and/or systemic medication including OTC preparation 14 days before day 1 of the study 10.Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL 11.Participation in any clinical trial within 3 months preceding day 1 of the study 12.Males and females of childbearing potential unwilling to employ an appropriate and reliable method of contraception, women with anticipated pregnancy/pregnant/lactating/ using oral contraceptives 13.Any other condition that, in the opinion of the investigator, could jeopardise the safety of the participant or affect the integrity of the study data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the safety of the intervention as measured by: i. Incidence of adverse events (AEs) and serious adverse events (SAEs) ii. Physical examination results iii. Incidence of abnormal vital signs.Timepoint: at baseline, day 30, day 60, and day 90 (end of the study) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the safety of the intervention as measured by i. Changes in biomarkers- Complete Blood Count (CBC), Liver Function test (LFT) and Renal Function Test (RFT), Thyroid Function Test, Lipid profile, Serum electrolytes, and Urine analysis, etc. ii. Changes in serum ferritin, serum iron, total iron binding capacity, Vitamin B12, estrogen (females), progesterone (females), and testosterone (males) 2. Treatment compliance & tolerabilityTimepoint: 1. i.at screening, day 30, day 60, and day 90 ii. at screening and day 90 2. at day 30, day 60, and day 90 | — |
Countries
India
Contacts
Public ContactDr Siddharth J Modi
Viridis Biopharma Pvt. Ltd
Outcome results
None listed