None listed
Conditions
Interventions
Intervention1: Test Arm: Akarkara (Anacyclus pyrethrum) Root Extract: Akarkara (Anacyclus pyrethrum) Root Extract
Control Intervention1: Placebo Arm: Placebo
Sponsors
K Patel Phyto Extractions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent for the study before the initiation of any study-specific procedures. 2. Healthy adults aged 21-50 years 3. No history of chronic diseases or sexual dysfunction 4. Not on any medication affecting sexual function 5. Willing to cooperate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately 6. Willingness to not using any treatment for sexual dysfunction and/or seeking performance enhancement and/or appetite-related concerns.
Exclusion criteria
Exclusion criteria: 1. High grade fever defined as body temperature grater then 40C. 2. Subjects with known or suspected hypersensitivity or intolerance to herbal products like turmeric, dandelion, ginger, or organic milk thistle extract 3. Has hypersensitivity to Investigational Product or related class of drugs or to any of the excipients of the formulation. 4. Subjects with liver function test markers above normal limits 5. Has presence of any liver related disease or abnormalities 6. History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects (1 drink = 5 ounce [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within the previous 6 months from screening. 7. Are addicted alcoholics and/or drug abusers. 8. Has history or presence of coronary, renal, pulmonary and thyroid disease. 9. Has used hypolipidemic medications as well as any drug known to affect hepatic function 4 weeks prior to randomization 10. Subjects with history of heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies 11. Subjects with history of immunocompromised state immune system with/ without organ transplant 12. Has difficulty in swallowing and retaining oral formulation. 13. Is known HBsAg positive, HCV and/or HIV positive. Has hereditary defects of iron, copper and alpha- 1 antitrypsin deficient subjects. 14. Has hypothyroidism, obstructive sleep apnea, total parenteral nutrition, short bowel syndrome, pancreatoduodenal resection that are known to have indirect impact on Liver functions. 15. Had condition or was in a situation that, in the investigator s opinion, had put the subject at a significant risk, had confounded study results, or had interfered significantly with the subject s participation in the study 16. Those who are not willing to abstain from other home-based remedies that include decoctions or any other form of dietary supplements during the entirety of study participation period. 17. Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, or other medications within one week of the start of the study. 18. Those who have severe mental illnesses, such as dementia, Parkinson s disease, Alzheimer s Disease, depression or anxiety disorders, or those who are currently taking psychoneurological drugs, such as antidepressants. 19. Those who have participated in other clinical trials within 30 days, prior to the screening visit or plan to participate in other clinical trials during the trial period. 20. Subjects who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study. 21. Individuals having a history of smoking or currently smoking or using any form of smokeless tobacco. 22. Females who are pregnant/planning to be pregnant/lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sexual Desire: Measured using the Sexual Desire Inventory (SDI) scale assessed Sexual Arousal: Assessed using the Sexual Arousal Scale (SAS) assessed Overall Sexual Function: Evaluated using the International Index of Erectile Function (IIEF) for males or the Female Sexual Function Index (FSFI) for females assessedTimepoint: Sexual Desire: Measured using the Sexual Desire Inventory (SDI) scale assessed at Baseline, 4 weeks and 9 weeks. Sexual Arousal: Assessed using the Sexual Arousal Scale (SAS) assessed at Baseline, 4 weeks and 9 weeks. Overall Sexual Function: Evaluated using the International Index of Erectile Function (IIEF) for males or the Female Sexual Function Index (FSFI) for females assessed at Baseline, 4 weeks and 9 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hormone analysis: Changes in Serum Level of Testosterone (free testosterone & total testosterone), Prolactin, FSH (Follicle-Stimulating Hormone), LH (Luteinizing Hormone) assessedTimepoint: at Baseline, 4 weeks & 9 weeks;Semen Analysis (for male Subjects): Parameters such as sperm count, motility, & morphology, assessedTimepoint: at baseline & 9 weeks;Sexual Satisfaction: Assessed through a self-reported Sexual Satisfaction Scale (SSS) assessedTimepoint: at Baseline, 4 weeks & 9 weeks.;Quality of Life: Evaluated using the SF-36 quality of life instrument assessedTimepoint: at Baseline, 4 weeks & 9 weeks;Tolerability & Safety: Monitoring of adverse events & side effectsTimepoint: throughout the study period | — |
Countries
India
Contacts
Public ContactMr Rashmin Lad
Methics Clinical Solutions Private Limited
Outcome results
None listed