CTRI/2015/04/005720Other未知
An exploratory study to assess the effect of topical application of iodex balm on local surface temperature using infra red thermal imaging technique.
试验速览
- 阶段
- 未知
- 状态
- Other
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
- •1.Satisfactory completion of the consent procedure (subject understanding of the study,willingness to participate and receiving of the signed and dated copy of the consent form).
- •2. age of the subject should be between 35 to 65.
- •3. Subject understands and is willing, able and likely to comply with all study procedures and restrictions.
- •4. Good general and mental health of the subject with, in opinion of the investigator or medically qualified designee
- •a. No clinically significant and relevant abnormalities of medical history or physical examination
- •b. Absence of any condition that would impact on the subject safety or well being or affect the individual ability to understand and follow study procedures and requirements.
- •5. Diagnosis subject is suffering from chronic osteoarthritis of knee joint as per ACR criteria for greater than three months.
- •6. Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.
排除标准
- •1. Pregnancy: women who are known to be pregnant or who are intending to become pregnant over the duration of the study or who have a positive urine pregnancy test
- •2.Breast-feeding: Women who are breast-feeding,
- •3. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity
- •to the study materials (or closely related compounds) or any of their stated ingredients,
- •4.Subject has current or relevant previous history of serious, severe or unstable physical or psychiatric illness, or medical disorders, such as current or previous history of hepatic ( or renal diseases (impairment) or peptic ulcer as determined by medical history,
- •5.Subject has psoriasis and/or active atopic dermatitis/eczema, and skin
- •infected lesions, burn or wound at th application site,
- •6.Clinical Study/Experimental Medication:
- •a. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit,
- •b. Previous participation in this study.
- •7. Subject is receiving topical NSAID, other topical analgesics/counterirritants/ mineral oils/Ayurvedic oils, or other medication (such as corticosteroid w thin 3 weeks of visit I) which, in the opinion of the investigative personnel, will interfere with the study results,
- •8. Subject on vasodilator drugs including anti-hypertensives, drugs for Peripheral vascular disease.
- •9.Substance abuse: Recent history (within the last one year) of alcohol or other substance abuse.
- •10.Personnel: An employee of the sponsor or the study site or members of their immediate family,
研究者
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