CTRI/2012/07/002819已完成2 期
An Open Labeled, Randomized, Multi-center, Parallel Group, Clinical Study to Evaluate Comparative Efficacy and Safety of Head Massage with NEW HIMANI NAVRATNA OIL and Coconut Oil in Patients Suffering from Mild to Moderate Anxiety and Stress - NI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects meeting all of the following criteria will be included to the trial-
- •1)Subjects suffering from mild to moderate anxiety (who achieve scores between 18 and 24 points on the Hamilton Scale for Anxiety)
- •2)Subject having age 20 to 65 years, both inclusive.
- •3)Subjects of female gender or a non-pregnant, non-lactating females, at least six weeks postpartum. A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
- •4)Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •Subjects meeting any of the following criteria will be excluded from the trial-
- •1)Subjects suffering from severe depression, schizophrenia, diabetes mellitus, heart disease, HIV/AIDS, kidney and liver diseases will not be recruited in the trial.
- •2)Subjects having addiction to any drug, including alcohol will not be recruited in the trial.
- •3)Subjects who are using any medication such as anxiolytic, anti-stress medication and under psychotherapy will not be recruited in the trial
- •4)Subjects on any other medications that could interfere with the effect of the drug under study will not be recruited in the study.
- •5)In addition, subject should have ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
- •6)Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •7)Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion,
- •8)Use of any other investigational drug within 1 month prior to randomization
- •9)Known hypersensitivity to ingredients used in study drug
- •10) Pregnant and Lactating females.
研究者
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