Deficiency Growth HormoneNCT03658187
Assessment of the Acute Effect of IP
A study testing IP in people with Deficiency Growth Hormone, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Deficiency Growth Hormone
- What is being tested?
- IP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 19 Jul 2018to 25 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Acute Effect of IP on hGH Levels in Aging Adults
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.
- Conditions
- Deficiency Growth Hormone
- Being tested
- Placebo, IP
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.
IPDietary supplement
Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo; Dietary Supplement: IP |
| IP | Experimental | 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. Receives: Dietary Supplement: Placebo; Dietary Supplement: IP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the plasma human growth hormone (hGH) levels in aging individuals
Change in serum hGH levels from baseline
Measured: Pre-dose: 0 hours and Post dose: 30, 60, 90,120 mins
Secondary outcomes (1)
Change on Visual Analogue Score for Fatigue
Change in Visual Analogue Scale score in IP and placebo.
Measured: From Day 0 to Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start19 Jul 2018
- Primary completion25 Oct 2018
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deficiency Growth HormoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shalini Srivastava, M.D., Study director, Vedic Lifesciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658187
- Sponsor's protocol ID
- DM/171201/HGH
- Status last verified
- May 2019
- First submitted
- 27 Aug 2018
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Acute Effect of IP on hGH Levels in Aging Adults
- ClinicalTrials.gov ID
- NCT03658187
- Acronym / sponsor ID
- DM/171201/HGH
- Conditions
- Deficiency Growth Hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Dietary Supplement: IP2 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 | Experimental | Dietary Supplement: Placebo, Dietary Supplement: IP2 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboBeige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid. | Dietary supplement | IP, Placebo |
| IPBeige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid. | Dietary supplement | IP, Placebo |
Primary outcome
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
1 secondary outcome
Change on Visual Analogue Score for Fatigue
Time frame: From Day 0 to Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Individual participant dataSharing planned: No
Related trials for Deficiency Growth Hormone
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalini Srivastava, M.D. study director
Vedic Lifesciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IP in people with Deficiency Growth Hormone, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.