All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019, India
NCT Number: NCT07143474
Given that testosterone is a key modulator of muscle protein synthesis and overall anabolic response to resistance training, any natural intervention that boosts testosterone levels could logically contribute to improved exercise performance, lean muscle gain, and subjective vitality. 13 However, despite encouraging preclinical and ethnopharmacological data, clinical validation of Curculigo extract in human participants-especially in the context of exercise and lifestyle enhancement-is lacking. A novel extract of Curculigo orchioides (commercially known as RhizomK™) has been developed. This randomized, double-blind, placebo-controlled study seeks to bridge this crucial gap by evaluating the efficacy and safety of RhizomK™ supplementation in healthy, physically active males. The findings of this study have the potential to substantiate RhizomK™ as a scientifically supported dietary intervention for enhancing hormonal balance, physical performance, and well-being in men who are not candidates for pharmacological therapy but are seeking to optimize their health through lifestyle and supplementation.
Trial opening soon.
Get Notified21 year–40 year
Male
Interventional
Not applicable
Bhubaneswar, Odisha, 751019, India
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
RhizomK 50 mg once daily
Placebo matching to RhizomK
Time frame: 4 weeks
A basal pre- intervention Saliva sample will be obtained for analysis of basal (resting) testosterone levels. One hour after ingestion of the assigned study product, the subject will undergo an acute resistance exercise routine. Resistance exercise will include the Leg Press. The post resistance-exercise session Salivary/Serum Testosterone samples within ~30 minutes of completing the exercise routine will be collected.
Time frame: 4 weeks
A basal pre- intervention Saliva sample will be obtained for analysis of basal (resting) cortisol levels. One hour after ingestion of the assigned study product, the subject will undergo an acute resistance exercise routine. Resistance exercise will include the Leg Press. The post resistance-exercise session Cortisol samples within ~30 minutes of completing the exercise routine will be collected.
Time frame: 4 weeks
The SF-36, or 36-Item Short Form Survey, is a widely used patient-reported outcome measure (PROM) that assesses health status. It's a multi-purpose questionnaire with 36 items assessing eight health concepts: physical functioning, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, vitality, and general health perceptions.
Time frame: 4 weeks
1-repetition maximum (1-RM) determined for the leg press
Time frame: 4 weeks
Proportion of patients in each group experiencing adverse effects
Contact information is provided by the study sponsor or research team.
Debasish Hota, DM
CONTACT
Rituparna Maiti, MD
CONTACT
All India Institute of Medical Sciences, Bhubaneswar
Other
A Randomized Double-blind Placebo Controlled Clinical Study to Evaluate the Impacts of RhizomK as Compared to Placebo on Testosterone Levels, the Anabolic Response to Exercise and Overall Quality of Life in Physically Active Healthy Males
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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