Assessment of the Acute Effect of IP

• ClinicalTrials.gov Identifier: NCT03658187
• Recruitment Status: Completed
• First Posted: September 5, 2018
• Last Update Posted: May 31, 2019
• Sponsor: Vedic Lifesciences Pvt. Ltd.
• Information provided by (Responsible Party): Vedic Lifesciences Pvt. Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Deficiency Growth Hormone	Dietary Supplement: Placebo; Dietary Supplement: IP	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Acute Effect of IP on hGH Levels in Aging Adults
• Actual Study Start Date: July 19, 2018
• Actual Primary Completion Date: October 25, 2018
• Actual Study Completion Date: January 25, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 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.	Dietary Supplement: Placebo; Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.; Dietary Supplement: IP; Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.
Experimental: 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.	Dietary Supplement: Placebo; Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.; Dietary Supplement: IP; Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.

Outcome Measures

Primary Outcome Measures :

1. Change in the plasma human growth hormone (hGH) levels in aging individuals [ Time Frame: Pre-dose: 0 hours and Post dose: 30, 60, 90,120 mins ]
   Change in serum hGH levels from baseline

Secondary Outcome Measures :

1. Change on Visual Analogue Score for Fatigue [ Time Frame: From Day 0 to Day 1 ]
   Change in Visual Analogue Scale score in IP and placebo.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

India

Vedic Lifesciences Pvt. Ltd

Mumbai, Opp Infinity Mall, India, 400053

Sponsors and Collaborators

Vedic Lifesciences Pvt. Ltd.

Investigators

• Study Director: Shalini Srivastava, M.D.; Vedic Lifesciences

More Information

• Responsible Party: Vedic Lifesciences Pvt. Ltd.
• ClinicalTrials.gov Identifier: NCT03658187
• Other Study ID Numbers: DM/171201/HGH
• First Posted: September 5, 2018
• Last Update Posted: May 31, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No