None listed
Conditions
Interventions
Intervention1: COLEUS FORSKOHLII EXTRACT: 2 capsules/ day for 14 days
(Each Capsule contains 133.35 mg of CFE 30%)
Control Intervention1: N/A: N/A
Sponsors
PIONEER EXTRACTS PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: •Male or female subjects between 20 to 50 years of age •Subject with BMI value less than 30 kg/m2 •Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera ®, or double-barrier and have a negative pregnancy test at the Screening Visit. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. •Subject should be available for duration of study period (2-3 months) •Subject agrees to come to site in fasting state for their physical, medical and other laboratory parameters examination at all the scheduled visits. •Subjects willing to give written informed consent and willing to comply with trial protocol.
Exclusion criteria
Exclusion criteria: •Subjects having headache, diarrhea, hypertensive, and alcoholic physical constitutions •Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain two months prior to screening. •Subjects having history of asthma •Subjects having history of cardiovascular diseases •Subjects having history of diabetes (Type I or Type II) •Subject with Hyperuricaemia (males > 480 µmol/L, females > 450 µmol/L) •Subjects having thyroid diseases •Subjects having abnormal liver or kidney function tests •Subjects having abnormal findings on complete blood count •Subjects having history of coagulopathies •Subjects with hypertension •Subjects with HIV Positive •Subjects having history of congestive heart failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Assessment by Clinical laboratory evaluationsTimepoint: 0 Day, 7th Day & 14th Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event Assessment Quality of Life AssessmentTimepoint: 0 Day, 7th Day & 14th Day | — |
Countries
India
Contacts
Public ContactDr K Venkateshwarlu
Ayurvedic Physician
Outcome results
None listed