A clinical study to evaluate the Safety of Jeevanprash (JP) in Healthy Individuals in Summer.
- Registration Number
- CTRI/2012/06/002713
- Lead Sponsor
- Alkem Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Subjects meeting all of the following criteria will be included to the trial-
• Males and Females, age group between 20-40 years
• Ready to provide written informed consent
• No significant diseases or clinically abnormal laboratory blood profiles during screening.
• ECG without significant abnormalities
• Be able to communicate effectively with study personnel
• No history of allergic conditions and is not on regular medical treatment
Subjects meeting any of the following criteria will be excluded from the trial-
• Any significant disease condition which would affect subjectâ??s participation or compliance to study protocol
• History of allergic conditions
• History of autoimmune disorders
• History of HIV I & II, Hepatitis.
• History or presence of dyspepsia, gastric ulcer or duodenal ulcer.
• History of any psychiatric disorders.
• Intake of any medication within 14 days before the start of the study.
• Recent history of alcoholism ( <2 years) or consumption of alcohol within 48 hours of receiving study medication.
• Smokers who cannot refrain from smoking during the study period.
• Presence of clinically significant abnormal laboratory results during screening.
• Pregnancy or not using appropriate means of contraception.
• History of drug addiction.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the clinical safety of JP in healthy individuals in summer by assessing Vital signs & symptoms, General and systemic examinationsTimepoint: Baseline to 35 days
- Secondary Outcome Measures
Name Time Method To assess the safety of JP in healthy individuals in summer by assessing <br/ ><br> <br/ ><br>1). Tolerability of the study drug by the subject at the end of 28 days of study treatment. <br/ ><br> <br/ ><br>2). Tolerability of the study drug by the investigator at the end of 28 days of study treatment. <br/ ><br> <br/ ><br>3). Incidence, severity and duration of adverse event(s). <br/ ><br> <br/ ><br>4). Laboratory investigations. <br/ ><br>Timepoint: Baseline to 35 days