A randomized, double blind, placebo controlled, cross over study to evaluate the safety and efficacy of a herbal capsule in patients with recent onset of mild to moderate joint knee pain
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- i.Decrease in elevated baseline inflammatory and pain markers.
研究概览
简要总结
Curcumin is the activechemical in turmeric root; it blocks inflammatory cytokines and enzymes in twoinflammatory pathways. Several human trials have shown an anti-inflammatorybenefit, which can translate to reduced joint pain and swelling. The yellowspice is popular in curries and other Indian dishes. Black pepper contains thebioactive compound piperine, which is an alkaloid like capsaicin, the activecomponent found in chili powder and cayenne pepper. Piperine has been shown tohelp relieve nausea, headaches and poor digestion and also hasanti-inflammatory properties. Still, its most significant benefit may be itsability to boost the absorption of curcumin. Research supports that combiningthe piperine in black pepper with the curcumin in turmeric enhances curcuminabsorption by up to 2,000%. Nuts and seeds are a great dietary source ofvitamin E and oils derived from sunflower seeds are rich in vitamin E. Evidencesuggests that increasing the intake of vitamin K sources such as kale, spinach,broccoli and Brussels sprouts may also benefit people with osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Volunteer aged between 18-55 years (both inclusive) 2)Knee joint pain since 1 month 3)Willingness to follow the protocol requirement as evidenced by written, informed consent.
- •Willingness to complete study questionnaires.
- •Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during the course of this study.
- •Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range.
排除标准
- •Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol 2)Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate) hematology, serum chemistry.
- •Diabetes mellitus and other auto-immune disorders like Rheumatoid Arthritis 4)Use of drugs that interfere with gastrointestinal motility and cardiac diseases 5)History of hypersensitivity reactions 6)History or presence of significant alcoholism or drug abuse in the past one year.
- •Participation in a clinical study during the preceding 90 days.
- •Previous abdominal surgery (except appendectomy) 9)Any contraindication to blood sampling.
- •Blood or blood products donated in past 30 days prior to study supplement administration.
- •Female subjects on pregnancy and lactating women.
结局指标
主要结局
i.Decrease in elevated baseline inflammatory and pain markers.
时间窗: Day-7,Day 0 and Day 8
ii.Decrease in elevated baseline anxiety markers.
时间窗: Day-7,Day 0 and Day 8
iii.Decrease in the pain and stress symptoms evaluated through questionnaire
时间窗: Day-7,Day 0 and Day 8
次要结局
- To assess the efficacy of herbal capsule in both stress/anxiety parameters(Day 0 and Day 8)