Assessment of the Acute Effect of IP
A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Acute Effect of IP on hGH Levels in Aging Adults
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 19, 2018
CompletedFirst Submitted
Initial submission to the registry
August 27, 2018
CompletedFirst Posted
Study publicly available on registry
September 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2019
CompletedMay 31, 2019
May 1, 2019
3 months
August 27, 2018
May 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change on Visual Analogue Score for Fatigue
From Day 0 to Day 1
Study Arms (2)
Placebo
PLACEBO COMPARATOR2 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
EXPERIMENTAL2 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vedic Lifesciences Pvt. Ltd
Mumbai, Opp Infinity Mall, 400053, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shalini Srivastava, M.D.
Vedic Lifesciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2018
First Posted
September 5, 2018
Study Start
July 19, 2018
Primary Completion
October 25, 2018
Study Completion
January 25, 2019
Last Updated
May 31, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share