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

NCT ID: NCT07143474

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-02-28

Brief Summary

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.

Conditions

Adult Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group RhizomK

Group Type: EXPERIMENTAL

RhizomK

Intervention Type: DRUG

RhizomK 50 mg once daily

Group Placebo

Group Type: PLACEBO_COMPARATOR

Plcebo

Intervention Type: OTHER

Placebo matching to RhizomK

Interventions

RhizomK

RhizomK 50 mg once daily

Intervention Type: DRUG

Plcebo

Placebo matching to RhizomK

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

All India Institute of Medical Sciences, Bhubaneswar

OTHER

Sponsor Role: lead

Responsible Party

Dr Debasish Hota

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Debasish Hota, DM

Role: PRINCIPAL_INVESTIGATOR

AIIMS, Bhubaneswar

Locations

All India Institute of Medical Sciences

Bhubaneswar, Odisha, India

Countries

India

Central Contacts

Debasish Hota, DM

Role: CONTACT

pharm_debasish@aiimsbhubaneswar.edu.in

9438884190

Rituparna Maiti, MD

Role: CONTACT

pharm_rituparna@aiimsbhubaneswar.edu.in

9438884191

Facility Contacts

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

Role: primary

9438884190

References

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.

Reference Type: BACKGROUND

PMID: 32082255 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24497673 (View on PubMed)

Other Identifiers

T/IM-NF/Pharm/25-26/29

Identifier Type: -

Identifier Source: org_study_id