Assessment of the Acute Effect of IP

Not Applicable

Completed

• Conditions: Deficiency Growth Hormone

• 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

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