Assessment of the Acute Effect of IP

Vedic Lifesciences

Status: Completed

Conditions: Deficiency Growth Hormone

Treatments: Dietary Supplement: IP; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03658187

DM/171201/HGH

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

2 tablets orally with water and 2 ml of liquid spray to be kept for 30 sec sublingually, before swallowing. To be taken half an hour before dinner prior to the day of site visit.

Treatment:

Dietary Supplement: IP

Dietary Supplement: Placebo

IP

Experimental group

Description:

2 tablets orally with water and 2 ml of liquid spray to be kept for 30 sec sublingually, before swallowing. To be taken half an hour before dinner prior to the day of site visit.

Treatment:

Dietary Supplement: IP

Dietary Supplement: Placebo