Effects of novel polyherbal formulation on cytochrome P450 enzymes mediated drug metabolism
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cmax, tmax, plasma half life (t1/2) , AUC0-t and AUC0-inf, AUC at steady state, elimination rate constant (Kel), clearance (Cl), volume of distribution (Vd)
研究概览
简要总结
A herbal formulation has been developed by interdisciplinarySchool of Indian System of Medicine (ISISM), SRM University in collaborationwith Banaras Hindu University, Varanasi for menopausal syndrome. Polyherbalformulation contains Dioscorea bulbifera, Terminalia arjuna, Bambusaarundinacea and Withania somnifera (Well established) plant extracts. Theformulation has been subjected to preclinical experiments to establish safety,efficacy, acute toxicity, sub-acute toxicity and chronic toxicity studies. Theeffective dose of each plant ingredient was determined based on the results ofpre-clinical studies by giving different doses of each plant extract in varyingconcentrations. The maximum optimum effect in specific dose on varioustargets/biomarkers involved with clinical condition was noticed and theeffective dose was taken for preparation of test formulation. The major safetyconcern is the potential for interactions of herbal products with prescribeddrugs. This issue is especially important with respect to drugs with narrowtherapeutic indexes (e.g. warfarin and digoxin). This may lead to adversereactions that are sometimes life-threatening or lethal. The identification ofdrugs that interact with herbs has important implications in drug development.It appears that any new drugs that are substrates for CYP3A4 have a potentialto cause herb-drug interactions. Thus, caution should be taken when these drugsare co-administered with herbs. Since in vitro drug-drug and drug-CYPinteraction studies have been incorporated into drug development, drug-herb andherb-CYP interactions should also be included to identify drugs that interactwith herbs in the early stage of drug development. So our purpose of the studyis to evaluate the drug-herb interaction of newly developed polyherbalformulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy female volunteers of 18 to 45 years (both years inclusive).
- •Willing to give informed written consent and comply with the study requirements.
- •Subject should be able to communicate effectively.
- •Non-smokers and Non-Alcoholic.
- •Body Mass Index (BMI) between 18.50 and 24.99 Kg/m
- •Healthy individuals as evaluated by personal history, medical history and general clinical examination.
- •Vital parameters.
- •BP should be within the range of 100 – 139 mmHg systolic and 60 – 89 mmHg diastolic. Pulse rate should be within the range of 60 – 100 / min. Oral temperature between 97.8 F and 99.0 F. Respiratory rate should be within the range of 14-18/min.
- •Normal biochemical, hematological and urinary parameters.
- •Normal Chest X.
- •ray PA view & ECG in 12 leads 10.Negative for HIV 1 & 2, Hepatitis B, Hepatitis C and Syphilis tests.
排除标准
- •Subjects incapable of understanding the informed consent.
- •History of any major surgical procedure in the past 3 months.
- •History of diabetes mellitus, tuberculosis and systemic hypertension.
- •Pregnant or lactating women.
- •History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric or hematological systems, judged to be clinically significant.
- •History of dysphagia.
- •History of any medical disorder that is of significance in the investigator’s opinion.
- •Present or past history of drug abuse.
- •History of hypersensitivity to study formulation.
- •History of allergy to vegetables and / or food substances and / or any other manifestations suggestive of hypersensitivity reactions.
- •Present or past history of intake of drugs which potentially modify kinetics / dynamics of study medication or any other medication judged to be clinically significant by the investigator.
- •Consumption of grapefruit / its products within 48 hours prior to the start of study.
- •Subject with clinically significant abnormal values of laboratory parameters.
- •Subject who had participated in any other clinical study during the last 3 months.
- •Subject who had bled in the past 3 months from the date of start of study either for blood donation or for any other reason.
- •History of habituation to coffee, tea or other xanthine containing products and inability to withhold the intake during the.
结局指标
主要结局
Cmax, tmax, plasma half life (t1/2) , AUC0-t and AUC0-inf, AUC at steady state, elimination rate constant (Kel), clearance (Cl), volume of distribution (Vd)
时间窗: 0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24th hour
次要结局
- Safety (adverse events)(Throughout study period)