None listed
Conditions
Interventions
Intervention1: GHS-6 Powder: One sachet daily after meal
Intervention2: SSG-3 Tablet: One tablet daily after meal
Intervention3: BASE-7 Tablet: One tablet daily after meal
Intervention4: CAM-8 Tablet:
Sponsors
HERBOLAB INDIA PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female human trial participants aged between 18 and 60 years (both inclusive);2. Female trial participants must have a negative urine pregnancy test prior to the housing;3. Male and females agreeing to use the contraceptive pill or abstinence as a method of contraception during and 07 days after completion of the study;4. Trial participants with a BMI between 18.50-29.90 kg per m2 and body mass, not less than 50.00 kg;5. Trial participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests).
Exclusion criteria
Exclusion criteria: 1.Incapable of understanding the informed consent information; 2.Clinically significant medical condition, such as, but not limited to, cardiovascular, neurological, psychiatric, pulmonary, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease), or uncontrolled haematological abnormalities; 3.History or presence of alcoholism or drug abuse; 4.History or presence of cancer; 5.Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinalproducts (including herbal remedies) during the week before study initiation and throughout the study; 6.Major illness during the 90 days before screening; 7.Pregnant women and nursing mothers; 8.Males and females of childbearing potential unwilling to employ appropriate and reliable method of contraception during the study till 07 days after the completion of the study; 9.Consumption of dietary supplements likely to provide constituents similar to the investigational product in last 3 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Assessment, Adverse events, Changes in CBC, LFT, and RFT parameters on screening and day 30.Timepoint: Screening and day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy testing by questionnaires.Timepoint: screening and day 30. | — |
Countries
India
Contacts
Public ContactDr Gayatri Ganu
Herbolab India Pvt. Ltd.
Outcome results
None listed