Deficiency Growth Hormone
Conditions
Brief summary
It is a nutraceutical system, consisting of oral tablet and an oral spray called Alpha GPC, which helps your body naturally restore the HGH levels.
Interventions
DIETARY_SUPPLEMENTPlacebo
Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.
DIETARY_SUPPLEMENTIP
Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.
Sponsors
Vedic Lifesciences Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females having age between 40-60 years (both inclusive) * BMI ≥25 and ≤29.9 kg/m2 * FBS ≤ 120 mg/dl * Serum hGH levels ≤0.94 ng/ml in females and ≤0.12 in males * Thyroid Stimulating Hormone ≥ 0.35 and ≤ 5.55 mIU/ml
Exclusion criteria
* History of thyroid disorder (Hyper/Hypo). * Smokers having at least 1 cigarette per day. * Known hypersensitivity or allergy to one or more of the ingredients of the IP * Participant suffering from primary or secondary insomnia with/without active treatment. * Alcoholics as defined by consumption of more than 2 standard alcoholic drinks (more than 30 ml/ day) for past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the plasma human growth hormone (hGH) levels in aging individuals | Pre-dose: 0 hours and Post dose: 30, 60, 90,120 mins | Change in serum hGH levels from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change on Visual Analogue Score for Fatigue | From Day 0 to Day 1 | Change in Visual Analogue Scale score in IP and placebo. |
Countries
India
Outcome results
None listed