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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 RhizomKâ„¢) has been developed. This randomized, double-blind, placebo-controlled study seeks to bridge this crucial gap by evaluating the efficacy and safety of RhizomKâ„¢ supplementation in healthy, physically active males. The findings of this study have the potential to substantiate RhizomKâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group RhizomK | Experimental |
| |
| Group Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RhizomK | Drug | RhizomK 50 mg once daily |
| |
| Plcebo |
| Measure | Description | Time Frame |
|---|---|---|
| Serum testosterone levels | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum cortisol levels | 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. |
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Inclusion Criteria:
Exclusion Criteria:
This study is being conducted to understand the effect of the drug on testosterone levels and anabolic response
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Debasish Hota, DM | Contact | 9438884190 | pharm_debasish@aiimsbhubaneswar.edu.in | |
| Rituparna Maiti, MD | Contact | 9438884191 | pharm_rituparna@aiimsbhubaneswar.edu.in |
| Name | Affiliation | Role |
|---|---|---|
| Debasish Hota, DM | AIIMS, Bhubaneswar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | Bhubaneswar | Odisha | 751019 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32082255 | Background | Hackney AC. Hypogonadism in Exercising Males: Dysfunction or Adaptive-Regulatory Adjustment? Front Endocrinol (Lausanne). 2020 Jan 31;11:11. doi: 10.3389/fendo.2020.00011. eCollection 2020. | |
| 24497673 | Background | Osterberg EC, Bernie AM, Ramasamy R. Risks of testosterone replacement therapy in men. Indian J Urol. 2014 Jan;30(1):2-7. doi: 10.4103/0970-1591.124197. |
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| Other |
Placebo matching to RhizomK |
|
| 4 weeks |
| Quality of life using SF-36 (Short Form 36-Item Health Survey) | 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. | 4 weeks |
| Exercise performance | 1-repetition maximum (1-RM) determined for the leg press | 4 weeks |
| Adverse effect | Proportion of patients in each group experiencing adverse effects | 4 weeks |