CTRI/2014/06/004673已完成3 期
Double blind, randomized placebo control study to evaluate efficacy and safety of EMTACT, a Homeopathic drug in the management of Recurrent Upper and Lower Respiratory Tract affections
Homeopathy India Private Limited0 个研究点目标入组 148 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
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
- •Having episodes of Recurrent Upper and/or Lower Respiratory Tract affections at least four times in previous six months, for at least for one day at a time.
- •At least one symptom from at least two of the location group symptoms, such as
- •Nasal symptoms (sneezing, running nose, nose block)
- •Throat symptoms (sore throat),
- •Bronchial symptoms (cough, wheezing)
- •Head and sinus symptoms (headache, face-ache)
- •General symptoms (fever, fatigue, low appetite)
- •Be willing to refrain from taking nasal decongestants, antihistamines or cough/cold preparations, antibiotics and homeopathic medicines during the trial period, unless symptoms are severe (define).
- •Written informed consent by patient, by child (assent form) and guardians of patient has been informed about the study and has given her/his written informed consent.
- •In the opinion of the investigator, able to comply with the requirements of the protocol
排除标准
- •Ongoing treatment for tuberculosis or untreated tuberculosis (to rule out by CBC, ESR, x-ray chest)
- •Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.
- •Homeopathic treatment for any chronic disease within l month.
- •Immuno-compromised patient(Known cases of Tuberculosis, HIV, Cancer)
- •Females who are pregnant or planning to become pregnant or lactating mother.
- •Patients who are scheduled to receive any other investigational drug during the course of the study
研究者
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