Joint Discomfort study: JDS-HF3.0
Official title JDS-HF3.0 Supplementation on Menopause Related Quality of Life Outcomes in Postmenopausal Women
ClinicalTrials.gov ID: NCT07238478
What this study is testing
- What it's testing
- This study is testing whether a daily supplement can reduce menopause symptoms. It looks at how well it works for joint pain and hot flashes.
- Who it's for
- You may be able to join if you are a woman between 50 and 70 years old.
- What's involved
- You would take a study product every day. You would also share how you feel about your symptoms.
- Time commitment
- The study lasts 12 weeks and involves taking the product daily.
- Time commitment: about 12 weeks
You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 70, women only. Healthy volunteers may be eligible.
You may be able to join if
- Healthy biological females who are 50-70 years of age (inclusive).
- Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
- Self-reported as postmenopause. Defined as 12 months without a menstrual cycle in individuals who undergo "Natural" Menopause (Not Surgically or...
- Have self-reported menopause related joint outcomes of moderate or severe severity according to a perceived discomfort greater or equal to 5 and less...
- Have self-reported \> or equal to 4 hot flashes on average per day.
You likely can't join if
- Individuals who are lactating, pregnant, or planning to become pregnant during the study.
- Active participation in a clinical trial.
- Use of any treatment for menopausal outcomes or other concomitant treatments for menopausal symptoms, joint health or at the discretion of the...
- Have a known sensitivity, intolerability, or allergy to any of the study product or their excipients.
- Use of Glucosamine and/or Chondroitin for joint outcomes in the last 3 months prior to screening.
- Received a COVID-19 vaccine in the 2 weeks prior to screening or during the study period, current COVID-19 infections or currently have the...
See the full eligibility criteria
Who can join
- Healthy biological females who are 50-70 years of age (inclusive).
- Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
- Self-reported as postmenopause. Defined as 12 months without a menstrual cycle in individuals who undergo "Natural" Menopause (Not Surgically or medically induced) and who have self-reported menopausal outcomes for the...
- Have self-reported menopause related joint outcomes of moderate or severe severity according to a perceived discomfort greater or equal to 5 and less than 10 on a scale of 0-10 (participants rating their discomfort 5-9...
- Have self-reported \> or equal to 4 hot flashes on average per day.
- In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
- Agree to refrain from treatments listed in Section 6.5 in the defined timeframe.
- Have reliable, stable access to Wi-Fi and a smart phone/device.
- Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read questionnaires, and carry out all study-related procedures.
What rules you out
- Individuals who are lactating, pregnant, or planning to become pregnant during the study.
- Active participation in a clinical trial.
- Use of any treatment for menopausal outcomes or other concomitant treatments for menopausal symptoms, joint health or at the discretion of the investigator.
- Have a known sensitivity, intolerability, or allergy to any of the study product or their excipients.
- Use of Glucosamine and/or Chondroitin for joint outcomes in the last 3 months prior to screening.
- Received a COVID-19 vaccine in the 2 weeks prior to screening or during the study period, current COVID-19 infections or currently have the post-COVID-19 condition as defined by World Health Organization (WHO) (i.e...
- Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (i.e., Lyme disease, TB, HIV).
- History of cancer (except localized skin cancer without metastases) within two (2) years prior to screening.
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study or influence the results or the...
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e., Crohn's disease, short bowel, acute...
- Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease...
- Major surgery in three months prior to screening or planned major surgery during the study.
- History of alcohol or substance abuse in the last 5 years.
- Has evidence of inflammatory rheumatic disease or other diagnosed anti-inflammatory disease.
- Has evidence of autoimmune disease(s).
- Chronic use of curcumin or curcuminoids in an herbal or dietary supplement. Note: Screened participants that are willing to undergo a washout period of at least 3 months prior to participation in the trial can be...
- Chronic pain medication and use of analgesics specifically for joint-related discomfort (i.e. Opiates, Tramadol) Note: Screened participants that are willing to undergo a washout period of at least 2 weeks during the...
- Have severe joint and/or severe bone deformities.
- Diagnosed bone fractures.
- Are a candidate for surgical joint replacement.
The study team makes the final eligibility decision.
Where it is enrolling
- Harrison, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 50 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Harrison, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.