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

NCT07143474 | Not Yet Recruiting

• 1 other identifier: T/IM-NF/Pharm/25-26/29
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Serum cortisol levels

  4 weeks

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

  4 weeks

• Exercise performance

  4 weeks

• Adverse effect

  4 weeks

Study Arms (2)

Group RhizomK

EXPERIMENTAL

Drug: RhizomK

Group Placebo

PLACEBO COMPARATOR

Other: Plcebo

Interventions

RhizomK DRUG

RhizomK 50 mg once daily

Group RhizomK

Plcebo OTHER

Placebo matching to RhizomK

Group Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: This study is being conducted to understand the effect of the drug on testosterone levels and anabolic response
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Takes any prescribed medication or over-the-counter medication which is known to affect testosterone levels.
• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences

Bhubaneswar, Odisha, 751019, India

Location

Related Publications (2)

• 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.

  PMID: 32082255 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.

  PMID: 24497673 BACKGROUND

Study Officials

• Debasish Hota, DM

  AIIMS, Bhubaneswar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debasish Hota, DM

CONTACT

9438884190; pharm_debasish@aiimsbhubaneswar.edu.in

Rituparna Maiti, MD

CONTACT

9438884191; pharm_rituparna@aiimsbhubaneswar.edu.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)