Assessment of the Acute Effect of IP

Deficiency Growth Hormone Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Acute Effect of IP on hGH Levels in Aging Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03658187
• Other study ID #: DM/171201/HGH
• Status: Completed
• Phase: N/A
• Start date: July 19, 2018
• Est. completion date: January 25, 2019

Study information

• Verified date: May 2019
• Source: Vedic Lifesciences Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 25, 2019
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deficiency Growth Hormone
• Dwarfism, Pituitary

Intervention

Dietary Supplement:
• Placebo
Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.
• IP
Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.

Locations

Country	Name	City	State
India	Vedic Lifesciences Pvt. Ltd	Mumbai	Opp Infinity Mall

Sponsors (1)

Lead Sponsor	Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the plasma human growth hormone (hGH) levels in aging individuals	Change in serum hGH levels from baseline	Pre-dose: 0 hours and Post dose: 30, 60, 90,120 mins
Secondary	Change on Visual Analogue Score for Fatigue	Change in Visual Analogue Scale score in IP and placebo.	From Day 0 to Day 1