Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2018-07-19
2019-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
60 Years
ALL
Yes
Sponsors
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Vedic Lifesciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Shalini Srivastava, M.D.
Role: STUDY_DIRECTOR
Vedic Lifesciences
Locations
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Vedic Lifesciences Pvt. Ltd
Mumbai, Opp Infinity Mall, India
Countries
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Other Identifiers
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DM/171201/HGH
Identifier Type: -
Identifier Source: org_study_id