Adult Healthy VolunteersNCT07143474
Effect of RhizomK on Testosterone Levels, the Anabolic Response to Exercise and Overall Quality of Life in Physically Active Healthy Males
A study testing RhizomK and Plcebo in people with Adult Healthy Volunteers, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adult Healthy Volunteers
- What is being tested?
- RhizomK and Plcebo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019
Debasish Hota, M.D.,D.M., 9438884190
Debasish Hota, M.D.,D.M.
About this study
Official 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
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
- Being tested
- RhizomK, Plcebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhizomKDrug
RhizomK 50 mg once daily
PlceboOther
Placebo matching to RhizomK
| Study group | Role | What they receive |
|---|---|---|
| Group RhizomK | Experimental | Not described Receives: Drug: RhizomK |
| Group Placebo | Placebo comparator | Not described Receives: Other: Plcebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 4 weeks
Exercise performance
1-repetition maximum (1-RM) determined for the leg press
Measured: 4 weeks
Adverse effect
Proportion of patients in each group experiencing adverse effects
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adult Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Debasish Hota, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- Debasish Hota, DM, Principal investigator, AIIMS, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143474
- Sponsor's protocol ID
- T/IM-NF/Pharm/25-26/29
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32082255Osterberg 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.
PubMed 24497673
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07143474
- Acronym / sponsor ID
- T/IM-NF/Pharm/25-26/29
- Conditions
- Adult Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group RhizomK | Experimental | Drug: RhizomK |
| Group Placebo | Placebo comparator | Other: Plcebo |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RhizomKRhizomK 50 mg once daily | Drug | Group RhizomK |
| PlceboPlacebo matching to RhizomK | Other | Group Placebo |
Primary outcome
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.
4 secondary outcomes
Serum cortisol levels
Time frame: 4 weeks
Quality of life using SF-36 (Short Form 36-Item Health Survey)
Time frame: 4 weeks
Exercise performance
Time frame: 4 weeks
Adverse effect
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Background: PubMed 32082255Hackney 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.
- Background: PubMed 24497673Osterberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Debasish Hota, DM principal investigator
AIIMS, Bhubaneswar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RhizomK and Plcebo in people with Adult Healthy Volunteers, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debasish Hota, DM (9438884190, pharm_debasish@aiimsbhubaneswar.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum testosterone levels (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07143474, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.