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

Plant Lipids Private Limited0 个研究点目标入组 30 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1)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.
•4)Willingness to complete study questionnaires.
•5)Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during the course of this study.
•6)Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range.

•1)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.
•3)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.
•7)Participation in a clinical study during the preceding 90 days.
•8)Previous abdominal surgery (except appendectomy)
•9)Any contraindication to blood sampling.
•10)Blood or blood products donated in past 30 days prior to study supplement administration.
•11)Female subjects on pregnancy and lactating women

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