Safety and efficacy study of herbal topical patch of pain relief
- Registration Number
- CTRI/2019/10/021738
- Lead Sponsor
- nexo Lifesciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 99
1)Age: 18 to 65 years (both inclusive) at the time of consent.
2)Sex: Male or non-pregnant/non-lactating females.
3)Females of Childbearing potential must have a negative urine pregnancy test performed on screening visit.
4)Subjects are having mild to severe acute pain (occurrence less than 48 hours) musculoskeletal pain (such as back pain, ankle pain, knee pain, shoulder pain, wrist pain) due to sprains, strains or sports injury.
5)Subjects are having VAS score >= 5 mm. [Mild >5 to Severe pain >100 mm].
6)Subjects must be able to understand and provide written informed consent to participate in the study.
7)Subjects should be willing and able to follow the study directions to participate in the study.
1)Subjects with history of any active cardiology conditions, respiratory conditions, metabolic disorders, urogenital conditions, liver disease, rheumatoid conditions or any chronic diseases.
2)Pregnancy or lactation period.
3)Females with childbearing potential without contraceptive methods.
4)Known allergy to ingredients of the study medication.
5)Known hypersensitivity to Gandhpura Oil (Wintergreen Oil), menthol, camphor, eucalyptus oil, clove oil etc. or any of the excipients.
6)Current skin disorders/open wounds in the area to be treated.
7)History of Drug and Alcohol abuse.
8)Any patient, in the investigators opinion not considered suitable for enrolment.
9)Use of non-steroid anti-inflammatory drugs, analgesics (e.g. acetyl salicylic acid, paracetamol) or psychotropic agents in the week before the study. Subjects who have experienced, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in subjects.
10)Subjects with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents.
11)Participation in a clinical study within the previous 30 days.
12)Any relevant surgical treatment during the previous two months or planned during the study.
13)Subjects on any prescription medicines that might interfere with the study outcome.
14)Known history of positive HIV.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method