A study to see the effects of application of iodex balm on skin surface temperature after application on knee of patients with osteoarthristis
- Conditions
- Health Condition 1: null- subject suffering from chronic osteoarthritis of Knee for three months
- Registration Number
- CTRI/2015/04/005720
- Lead Sponsor
- GlaxoSmithKline Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
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.
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,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method