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NCT Number: NCT07143474

Effect of RhizomK on Testosterone Levels, the Anabolic Response to Exercise and Overall Quality of Life in Physically Active Healthy Males

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.

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Key information

Age range

21 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

All India Institute of Medical Sciences

Bhubaneswar, Odisha, 751019, India

Location contact

Debasish Hota, M.D.,D.M.

CONTACT

9438884190

Debasish Hota, M.D.,D.M.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male sex, aged 21 to 40 (inclusive)
  • Currently engaged in, and has been engaged in resistance training
  • (i.e., weightlifting), training three or more times per week for at least
  • the prior 12 months.
  • Healthy subject (no medical conditions that per the PI assessment).
  • No significant past medical history
  • No significant past surgical history that in the opinion of the PI
  • would preclude study participation.
  • Passes the screening with Physical Activity Readiness questionnaire (PAR-Q)
  • Not currently or recently (within the prior eight-weeks) taken a
  • dietary supplement that is purported to increase testosterone
  • levels.
  • Agrees to follow and adhere to the study directions.
  • Agrees that their study visits will be scheduled at a similar time of the day
  • to minimize and potential circadian rhythm impacts.

Exclusion criteria

  • Takes any prescribed medication or over-the-counter medication which is known to affect testosterone levels.
  • Positive medical history of heart disease/cardiovascular disease, high blood pressure (140/90 or greater mmHg), kidney disease, hepatic impairment or disease, or Type I or Type II diabetes or any other medical condition or diagnosis that the PI would deem exclusionary.
  • Positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit.
  • Positive medical history for any gastrointestinal disease or illness Positive history of gastrointestinal surgery that is known to alter or impact the digestion, absorption of nutrients and or fluids (i.e., gastric bypass).
  • History of hospitalization or in-patient or out-patient treatment for alcohol dependence or drug addiction over the past one year.
  • History of hospitalization or in-patient treatment for depression or any mental health related condition within the past one year.
  • Allergic to any of the ingredients in the study product.
  • Subject is unwilling to follow study directions.

Treatment and study plan

RhizomK

Drug

RhizomK 50 mg once daily

Plcebo

Other

Placebo matching to RhizomK

Primary outcomes

  1. Serum testosterone levels

    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.

Secondary outcomes

  1. Serum cortisol levels

    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.

  2. Quality of life using SF-36 (Short Form 36-Item Health Survey)

    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.

  3. Exercise performance

    Time frame: 4 weeks

    1-repetition maximum (1-RM) determined for the leg press

  4. Adverse effect

    Time frame: 4 weeks

    Proportion of patients in each group experiencing adverse effects

Study contacts

Contact information is provided by the study sponsor or research team.

Debasish Hota, DM

CONTACT

[email protected]

9438884190

Rituparna Maiti, MD

CONTACT

[email protected]

9438884191

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 27, 2025
Registry last updated
Sep 4, 2025

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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