HealthyNCT06138444
Effect of Cordyceps Militaris Beverage on the Immune Response
A study testing Functional beverages from the submerged fermentation of Cordyceps militaris and Fruit juice in people with Healthy, run by University of Phayao at 1 site in Thailand.
Trial summary
This study developed functional beverages from the submerged fermentation of Cordyceps militaris (FCM) and aimed to investigate the potential of FCM in male and female healthy volunteers in Phayao province, Thailand. To provide essential information for the development of healthy drink products. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Functional beverages from the submerged fermentation of Cordyceps militaris and Fruit juice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 22 Nov 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female adult participants aged 25-60 during the screening test.
- No history of hypersensitivity or idiosyncratic reactions to drugs or herbal products.
- Willing to participate in the project throughout the research program.
Who cannot join
- Participants diagnosed with immune-mediated disease, nervous system disorders, cardiovascular disease, or liver or kidney disease.
- Participants diagnosed with chronic health problems such as hypertension, diabetes, or renal failure, etc.
- A body mass index (BMI) greater than 29.9 or less than 18 kg/m2.
- Participants who were pregnant or lactating or intended to become pregnant during the trial period.
- Participants who, within two weeks, ingested a drug or functional food that may affect the immunomodulatory effect of the test product
- Participants who had an alanine transaminase (ALT) or aspartate transaminase (AST) plasma level more than three times the guideline of the organization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial of Cordyceps Militaris Beverage on the Immune Response
This study developed functional beverages from the submerged fermentation of Cordyceps militaris (FCM) and aimed to investigate the potential of FCM in male and female healthy volunteers in Phayao province, Thailand. To provide essential information for the development of healthy drink products.
Read the detailed description
Healthy Thai males and females aged 25-60 were recruited at the School of Medical Sciences, University of Phayao, in 2022. Written informed consent was obtained from all research participants. A total of 40 participants were randomly assigned to one of the study groups (10 subjects each).
Inclusion Criteria :
- Male and female adult participants aged 25-60 during the screening test.
- No history of hypersensitivity or idiosyncratic reactions to drugs or herbal products.
- Willing to participate in the project throughout the research program.
Exclusion Criteria :
- Participants diagnosed with immune-mediated disease, nervous system disorders, cardiovascular disease, or liver or kidney disease.
- Participants diagnosed with chronic health problems such as hypertension, diabetes, or renal failure, etc.
- A body mass index (BMI) greater than 29.9 or less than 18 kg/m2.
- Participants who were pregnant or lactating or intended to become pregnant during the trial period.
- Participants who, within two weeks, ingested a drug or functional food that may affect the immunomodulatory effect of the test product.
- Participants who had an alanine transaminase (ALT) or aspartate transaminase (AST) plasma level more than three times the guideline of the organization.
Laboratory research has been conducted to confirm the eligibility of research participants, including hematology, serum biochemistry, blood coagulation, and urinalysis. The participants who met the inclusion requirements were randomized into experimental groups. Twenty random numbers were generated using Statistical Package for the Social Sciences (SPSS) 26.0. Digits 1st-10th of each gender were numbered as the FCM group, and the remaining digits, 11th-20th of each gender, were numbered as the placebo group. All researchers, participants, and related medical staff were blinded to the intervention assignments throughout the study.
- Conditions
- Healthy
- Being tested
- Functional beverages from the submerged fermentation of Cordyceps militaris, Fruit juice
- Keywords
- Cordyceps militaris, Healthy subjects, NK cell, Cytokine, Immunomodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional beverages from the submerged fermentation of Cordyceps militarisDietary supplement
Also called FCM
The Cordyceps militaris submerged fermentation in fruit juice.
Fruit juiceOther
Also called Placebo
Fruit juice is used as a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Male received functional beverages | Experimental | Male received single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM) Receives: Dietary Supplement: Functional beverages from the submerged fermentation of Cordyceps militaris |
| Male received placebo | Placebo comparator | Male received placebo Receives: Other: Fruit juice |
| Female received functional beverages | Experimental | Female received single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM) Receives: Dietary Supplement: Functional beverages from the submerged fermentation of Cordyceps militaris |
| Female received placebo | Placebo comparator | Female received placebo Receives: Other: Fruit juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline on physical examination (Height)
The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for height (Centimeter).
Measured: At 0, 4 and 8 weeks after end of the intervention
Change from the baseline on the physical examination (Weight)
The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for weight (Kilogram).
Measured: At 0, 4 and 8 weeks after end of the intervention
Change from the baseline on the physical examination (Blood pressure)
The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for blood pressure using an automatic blood pressure monitor (mmHg).
Measured: At 0, 4 and 8 weeks after end of the intervention
Change from the baseline on the physical examination (oxygen saturation)
The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for oxygen saturation using a fingertip pulse oximeter (%).
Measured: At 0, 4 and 8 weeks after end of the intervention
Change from the baseline on the physical examination (adverse reactions)
The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for adverse reactions (Questionnaire).
Measured: At 0, 4 and 8 weeks after end of the intervention
Change from the baseline on the immune response (NK cells)
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in natural killer cells (NK cells), measurement by using flow cytometry-based assays.
Measured: At 0, 4 and 8 weeks after end of the intervention
Change from the baseline on the cluster of differentiation (CD) antigens
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection.
This experiment examined the changes in cluster of differentiation (CD) antigens
- Cluster of differentiation 3 (CD3)
- Cluster of differentiation 4 (CD4)
- Cluster of differentiation 8 (CD8)
- B-lymphocyte antigen CD19 (CD19)
Measurement by using flow cytometry-based assays.
Measured: At 0, 4 and 8 weeks after end of the intervention
Change from the baseline on the immunoglobulins
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection.
This experiment examined the changes in immunoglobulins
- Immunoglobulin A (IgA)
- Immunoglobulin G (IgG)
- Immunoglobulin M (IgM)
Measurement by using flow cytometry-based assays.
Measured: At 0, 4 and 8 weeks after end of the intervention
Change from the baseline on the inflammatory cytokines
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection.
This experiment examined the changes in inflammatory markers
- Tumor necrosis factor alpha (TNF-α)
- Interleukin 1 beta (IL-1β)
- Interleukin 6 (IL-6)
Measurement by using ELISA assay.
Measured: At 0, 4 and 8 weeks after end of the intervention
Change from the baseline on the safety parameters (Complete blood count (CBC))
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in complete blood count (CBC), measurement by using colorimetric assays.
Measured: At 0, 4 and 8 weeks after end of the intervention
Change from the baseline on the safety parameters (Fasting blood glucose)
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in fasting blood glucose, measurement by using colorimetric assays.
Measured: At 0, 4 and 8 weeks after end of the intervention
Change from the baseline on the safety parameters (Plasma lipids)
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection.
This experiment examined the changes in safety parameters
- Triglyceride
- Total cholesterol
Measurement by using colorimetric assays.
Measured: At 0, 4 and 8 weeks after end of the intervention
Change from the baseline on the safety parameters (Renal function)
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection.
This experiment examined the changes in safety parameters
- Creatinine
- Total protein
Measurement by using colorimetric assays.
Measured: At 0, 4 and 8 weeks after end of the intervention
Change from the baseline on the safety parameters (Liver function)
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection.
This experiment examined the changes in safety parameters
- Aspartate aminotransferase (AST)
- Alanine aminotransferase (ALT)
Measurement by using colorimetric assays.
Measured: At 0, 4 and 8 weeks after end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start22 Nov 2022
- Primary completion10 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- Male or female received a single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM) or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Phayao
- Sponsor type
- University, hospital or other
- Collaborators
- National Innovation Agency (NIA)
- Responsible party
- Principal investigator, Atcharaporn Ontawong, University of Phayao
- Investigators
- Atcharaporn Ontawong, Ph.D., Principal investigator, University of Phayao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138444
- Sponsor's protocol ID
- UP-HEC 1.3/026/65
- Status last verified
- Nov 2023
- First submitted
- 17 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Prohibited from laws (contracts)
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Cordyceps Militaris Beverage on the Immune Response
- ClinicalTrials.gov ID
- NCT06138444
- Acronym / sponsor ID
- UP-HEC 1.3/026/65
- Conditions
- Healthy
- Keywords
- Cordyceps militaris, Healthy subjects, NK cell, Cytokine, Immunomodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PhayaoUniversity, hospital or other
- Collaborators
- National Innovation Agency (NIA)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 18 Nov 2023 (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.
This study developed functional beverages from the submerged fermentation of Cordyceps militaris (FCM) and aimed to investigate the potential of FCM in male and female healthy volunteers in Phayao province, Thailand. To provide essential information for the development of healthy drink products.
Detailed description
Healthy Thai males and females aged 25-60 were recruited at the School of Medical Sciences, University of Phayao, in 2022. Written informed consent was obtained from all research participants. A total of 40 participants were randomly assigned to one of the study groups (10 subjects each).
Inclusion Criteria :
- Male and female adult participants aged 25-60 during the screening test.
- No history of hypersensitivity or idiosyncratic reactions to drugs or herbal products.
- Willing to participate in the project throughout the research program.
Exclusion Criteria :
- Participants diagnosed with immune-mediated disease, nervous system disorders, cardiovascular disease, or liver or kidney disease.
- Participants diagnosed with chronic health problems such as hypertension, diabetes, or renal failure, etc.
- A body mass index (BMI) greater than 29.9 or less than 18 kg/m2.
- Participants who were pregnant or lactating or intended to become pregnant during the trial period.
- Participants who, within two weeks, ingested a drug or functional food that may affect the immunomodulatory effect of the test product.
- Participants who had an alanine transaminase (ALT) or aspartate transaminase (AST) plasma level more than three times the guideline of the organization.
Laboratory research has been conducted to confirm the eligibility of research participants, including hematology, serum biochemistry, blood coagulation, and urinalysis. The participants who met the inclusion requirements were randomized into experimental groups. Twenty random numbers were generated using Statistical Package for the Social Sciences (SPSS) 26.0. Digits 1st-10th of each gender were numbered as the FCM group, and the remaining digits, 11th-20th of each gender, were numbered as the placebo group. All researchers, participants, and related medical staff were blinded to the intervention assignments throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Male or female received a single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM) or placebo.
| Arm | Type | Receives |
|---|---|---|
| Male received functional beverages | Experimental | Dietary Supplement: Functional beverages from the submerged fermentation of Cordyceps militarisMale received single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM) |
| Male received placebo | Placebo comparator | Other: Fruit juiceMale received placebo |
| Female received functional beverages | Experimental | Dietary Supplement: Functional beverages from the submerged fermentation of Cordyceps militarisFemale received single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM) |
| Female received placebo | Placebo comparator | Other: Fruit juiceFemale received placebo |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female adult participants aged 25-60 during the screening test.
- No history of hypersensitivity or idiosyncratic reactions to drugs or herbal products.
- Willing to participate in the project throughout the research program.
Key exclusion criteria (6 listed)
- Participants diagnosed with immune-mediated disease, nervous system disorders, cardiovascular disease, or liver or kidney disease.
- Participants diagnosed with chronic health problems such as hypertension, diabetes, or renal failure, etc.
- A body mass index (BMI) greater than 29.9 or less than 18 kg/m2.
- Participants who were pregnant or lactating or intended to become pregnant during the trial period.
- Participants who, within two weeks, ingested a drug or functional food that may affect the immunomodulatory effect of the test product
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 |
|---|---|---|
| Functional beverages from the submerged fermentation of Cordyceps militarisAlso: FCMThe Cordyceps militaris submerged fermentation in fruit juice. | Dietary supplement | Female received functional beverages, Male received functional beverages |
| Fruit juiceAlso: PlaceboFruit juice is used as a placebo. | Other | Female received placebo, Male received placebo |
Primary outcome
Change from the baseline on physical examination (Height)
Time frame: At 0, 4 and 8 weeks after end of the intervention
The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for height (Centimeter).
Change from the baseline on the physical examination (Weight)
Time frame: At 0, 4 and 8 weeks after end of the intervention
The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for weight (Kilogram).
Change from the baseline on the physical examination (Blood pressure)
Time frame: At 0, 4 and 8 weeks after end of the intervention
The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for blood pressure using an automatic blood pressure monitor (mmHg).
Change from the baseline on the physical examination (oxygen saturation)
Time frame: At 0, 4 and 8 weeks after end of the intervention
The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for oxygen saturation using a fingertip pulse oximeter (%).
Change from the baseline on the physical examination (adverse reactions)
Time frame: At 0, 4 and 8 weeks after end of the intervention
The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for adverse reactions (Questionnaire).
Change from the baseline on the immune response (NK cells)
Time frame: At 0, 4 and 8 weeks after end of the intervention
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in natural killer cells (NK cells), measurement by using flow cytometry-based assays.
Change from the baseline on the cluster of differentiation (CD) antigens
Time frame: At 0, 4 and 8 weeks after end of the intervention
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in cluster of differentiation (CD) antigens 1. Cluster of differentiation 3 (CD3) 2. Cluster of differentiation 4 (CD4) 3. Cluster of differentiation 8 (CD8) 4. B-lymphocyte antigen CD19 (CD19) Measurement by using flow cytometry-based assays.
Change from the baseline on the immunoglobulins
Time frame: At 0, 4 and 8 weeks after end of the intervention
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in immunoglobulins 1. Immunoglobulin A (IgA) 2. Immunoglobulin G (IgG) 3. Immunoglobulin M (IgM) Measurement by using flow cytometry-based assays.
Change from the baseline on the inflammatory cytokines
Time frame: At 0, 4 and 8 weeks after end of the intervention
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in inflammatory markers 1. Tumor necrosis factor alpha (TNF-α) 2. Interleukin 1 beta (IL-1β) 3. Interleukin 6 (IL-6) Measurement by using ELISA assay.
Change from the baseline on the safety parameters (Complete blood count (CBC))
Time frame: At 0, 4 and 8 weeks after end of the intervention
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in complete blood count (CBC), measurement by using colorimetric assays.
Change from the baseline on the safety parameters (Fasting blood glucose)
Time frame: At 0, 4 and 8 weeks after end of the intervention
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in fasting blood glucose, measurement by using colorimetric assays.
Change from the baseline on the safety parameters (Plasma lipids)
Time frame: At 0, 4 and 8 weeks after end of the intervention
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in safety parameters 1. Triglyceride 2. Total cholesterol Measurement by using colorimetric assays.
Change from the baseline on the safety parameters (Renal function)
Time frame: At 0, 4 and 8 weeks after end of the intervention
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in safety parameters 1. Creatinine 2. Total protein Measurement by using colorimetric assays.
Change from the baseline on the safety parameters (Liver function)
Time frame: At 0, 4 and 8 weeks after end of the intervention
Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in safety parameters 1. Aspartate aminotransferase (AST) 2. Alanine aminotransferase (ALT) Measurement by using colorimetric assays.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No. Prohibited from laws (contracts)
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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. This study is not recruiting at the moment.
Atcharaporn Ontawong, Ph.D. principal investigator
University of Phayao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional beverages from the submerged fermentation of Cordyceps militaris and Fruit juice in people with Healthy, run by University of Phayao at 1 site in Thailand.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 18 Nov 2023. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the baseline on physical examination (Height) (time frame: At 0, 4 and 8 weeks after end of the intervention). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.