Assessment of the Acute Effect of IP

Not Applicable

Completed

• Conditions: Deficiency Growth Hormone
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: IP

• Registration Number: NCT03658187
• Lead Sponsor: Vedic Lifesciences Pvt. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-19
• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-09-01
• Study First Posted: 2018-09-05
• Primary Completion: 2018-10-25
• Study Completion: 2019-01-25
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-29
• Last Update Posted: 2019-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Placebo	IP	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.
IP	Placebo	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.
IP	IP	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change on Visual Analogue Score for Fatigue	From Day 0 to Day 1	Change in Visual Analogue Scale score in IP and placebo.

Trial Locations

Locations (1)

Vedic Lifesciences Pvt. Ltd; 🇮🇳 Mumbai, Opp Infinity Mall, India