Health Condition 1: null- subject suffering from chronic osteoarthritis of Knee for three months
Conditions
Interventions
Intervention1: Iodex Balm: Approximately 2gms single application in a cross-over fashion at a gap of 3 days between the two product application.
Control Intervention1: Placebo Balm: Approximately 2gms
Sponsors
GlaxoSmithKline Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time taken to bring about a Significant increase in the local surface temperature assessed at every minute for first 10 minutes after application , measured by Infra-Red Thermography (IRT)Timepoint: Day 0 and Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactRashi Nangia
CIDP Biotech India Pvt Ltd
Outcome results
None listed