None listed
Conditions
Interventions
Intervention1: GenF20 Plus Tablets & liquid: 2 Tablets in the morning with 2 ml sub-lingual liquid and 2 tablets in the evening with 2 ml sub-lingual liquid for 84 Days
Control Intervention1: Placebo:
Sponsors
Leading Edge Marketing
Leading Edge Marketing
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adults with any 2 of the following conditions: poor quality of sleep, decreased memory, decreased libido and low energy levels ? with the affected parameters (of sleep, memory, libido and energy levels) perceived to be of grade 1 or 2 on a Likert scale. The above conditions should have been present since at least 1 month. 2) Body Mass Index between 18.5 to 29.9 kg/m2 3) Willing to give written informed consent and abide with trial procedures and come for the follow up visits 4) Women willing to practice suitable contraception (except oral contraceptives) during the study 5) Willing to continue current lifestyle practices with no modifications (in diet and exercise ) during the study period
Exclusion criteria
Exclusion criteria: 1) Adults with uncontrolled conditions of diabetes, hypertension, hypothyroidism, hyperthyroidism 2) Hepatic or renal impairment 3) Women on oral contraceptives, estrogen supplements and corticosteroids 4) Significant cardiovascular co-morbidities, e.g. symptomatic heart failure, a history of ischemic heart disease (as evident from ECG), history of stroke and/or TIA. 5) Women with estrogen sensitive disorders like breast cancer, uterine cancer, ovarian cancer, endometriosis and uterine fibroids 6) Debilitating neurological or psychiatric disorders including seizure disorders and depression. 7) Known hypersensitivity or allergy to one or more of the ingredients of the IP. 8) Known history of allergy to milk and milk products. 9) Recent ( 1 month) participation in a clinical trial 10) Any condition likely to hinder the compliance with the protocol. 11) Heavy smoking (more than 10 cigarettes per day) or chronic alcoholics. 12) Pregnant and lactating women 13) Subjects who have begun an exercise and/or diet regimen within 30 days of the screening visit 14) Known cases of acromegaly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin Growth Factor - 1Timepoint: Screening Visit & Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To assess the effect of the IP on the quality of life sleep, memory, libido and energy using QoL questionnaire Timepoint: 1) Quality of Life Questionnaire - Day -5, Day 0, Day 28, Day 56, Day 84 2) Monitoring of AE/SAE - Day 1, Day 28, Day 56, Day 84 | — |
Countries
India
Contacts
Public ContactSeema Damakale
Vedic Lifesciences Pvt. Ltd.
Outcome results
None listed