An open-label, single-arm, clinical study to evaluate the safety of standardised leaf extract of Dalbergia sissoo (OsteoCaf TM) Capsules in healthy adult volunteers.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. To assess the safety of the intervention as measured by:
研究概览
简要总结
Osteoporosis, fractures, and other metabolic bone disorders represent a significant and growing public health concern, particularly among ageing populations and postmenopausal women. Current pharmacological treatments, while effective, often carry adverse effects or limitations in long-term use, highlighting the need for safer, well-tolerated alternatives. Dalbergia sissoo (Indian Rosewood) has been traditionally used in Ayurvedic medicine for managing musculoskeletal conditions such as joint pain, inflammation, and bone-related ailments. Preclinical studies have demonstrated that standardised extracts from Dalbergia sissoo, particularly its leaf and heartwood, possess osteogenic, anti-inflammatory, and antioxidant properties, promoting fracture healing and preventing bone loss through osteoblast stimulation and improved bone microarchitecture.
OsteoCaf™ is a standardised extract derived from Dalbergia sissoo, formulated specifically to support bone health and aid in the management of conditions like osteoporosis and fracture recovery. While clinical safety data in humans remains limited. Establishing human safety through a clinical study is a critical first step before exploring efficacy in at-risk or diseased populations. This open-label, single-arm study is thus designed to evaluate the safety of OsteoCaf™ capsules in healthy adult volunteers, generating essential data to support its future clinical development as a safe botanical intervention for bone health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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;
- •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.
结局指标
主要结局
1. To assess the safety of the intervention as measured by:
时间窗: at baseline, day 30, day 60, and day 90 (end of the study)
i. Incidence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: at baseline, day 30, day 60, and day 90 (end of the study)
ii. Physical examination results
时间窗: at baseline, day 30, day 60, and day 90 (end of the study)
iii. Incidence of abnormal vital signs.
时间窗: at baseline, day 30, day 60, and day 90 (end of the study)
次要结局
- 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.)
研究者
Dr Ram Mundhe
Gunjkar Multispeciality Hospital