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| ID | Type | Description | Link |
|---|---|---|---|
| 13364-TAVanDusseldorp | Other Identifier | Sterling IRB |
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The goal of this interventional study is to evaluate whether the study product can help improve quality of life and reduce common menopause symptoms-such as joint discomfort, hot flashes and night sweats-in women aged 50-70. The primary research question is whether taking the study product daily for 12 weeks can reduce the severity and frequency of menopause-related symptoms.
About 250 women across the U.S. will take part in this study. Participants will be randomly placed into one of two groups-one will take the active study product, and the other will take a placebo. All participants will take two tablets each morning for about 12 weeks. The total time the participant will be in the study is about 14 weeks, including the time it takes to collect baseline values.
All parts of the study are done virtually, in-person visits are not required. The participant will take part in five virtual check-ins, including a screening visit, a baseline visit, two check-ins during the study, and a final visit at the end. Throughout the study, the participant will be asked to complete daily diaries and weekly and monthly questionnaires to report on their symptoms and how they are feeling. These will include questions about hot flashes, night sweats, physical comfort, and overall well-being. The study is led by a research team based in Harrison, NY, USA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JDS-HF3.0 Active Group | Active Comparator | Group of participants supplementing with JDS-HF3.0 |
|
| Placebo Comparator | Placebo Comparator | Group consuming nonactive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JDS-HF3.0 | Dietary Supplement | Active Supplement JDS-HF3.0 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Menopause Related Quality of Life Outcomes | Change from baseline in scores for severity of perceived joint discomfort, frequency of perceived joint discomfort, perceived joint mobility and perceived daily mobility assessed via a Visual Analog Scale (VAS). Response options will range from 0-100, with a higher score reflecting the worse outcome. | From enrollment to the end of study at 12 weeks |
| Change from Baseline in Menopause Related Quality of Life Outcomes | Change from baseline in scores for Arthralgia Inventory (PRAI) score. The rating scale ranges from 0-10, with a higher score indicating a worse outcome. | From enrollment to the end of study at 12 weeks |
| Change from Baseline in Menopause Related Quality of Life Outcomes | Change from baseline in scores for Musculoskeletal Health Questionnaire (MSK-HQ) score. Each response ranges from "not at all" to "very severe", with a higher score indicating a better outcome. | From enrollment to the end of study at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline on Overall Menopausal Symptoms | Change from baseline in scores for the following: Menopause Specific Quality of Life Questionnaire (MENQOL). Each question being scored from 0 to 6, with 6 being the worse outcome. | From enrollment to the end of study at 12 weeks |
| Change from Baseline on Overall Menopausal Symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Reports of Adverse Events | Assess the safety and tolerability of the study product in healthy participants | From baseline to the end of study at 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
Cisgender Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trisha VanDusseldorp, PhD | Contact | 233-266-2343 | tvandusseldorp@bonafidehealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bonafide Health | Recruiting | Harrison | New York | 10528 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15345062 | Background | Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45. | |
| 32311961 | Background | Shep D, Khanwelkar C, Gade P, Karad S. Efficacy and safety of combination of curcuminoid complex and diclofenac versus diclofenac in knee osteoarthritis: A randomized trial. Medicine (Baltimore). 2020 Apr;99(16):e19723. doi: 10.1097/MD.0000000000019723. |
| Label | URL |
|---|---|
| Epigallocatechin-3-gallate (EGCG): Chemical and biomedical perspectives | View source |
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Data will be privately owned.
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| Placebo |
| Other |
Nonactive Placebo |
|
Change from baseline in scores for Menopausal Rating Scale (MRS).Each question is rated on a 5-point scale with the higher number correlating with the more severe symptoms and worse outcome. |
| From enrollment to the end of study at 12 weeks |
| Change from Baseline on Overall Menopausal Symptoms | Change from baseline in the frequency of menopause related hot flashes assessed via daily diaries. Daily diaries include the number of total vasomotor occurrences, the severity of total vasomotor occurrences and the number of times awoke during the night due to night sweat occurrences. | From enrollment to the end of study at 12 weeks |
| 30975196 | Background | Shep D, Khanwelkar C, Gade P, Karad S. Safety and efficacy of curcumin versus diclofenac in knee osteoarthritis: a randomized open-label parallel-arm study. Trials. 2019 Apr 11;20(1):214. doi: 10.1186/s13063-019-3327-2. |
| 19390977 | Background | Kumar N, Singh S, Patro N, Patro I. Evaluation of protective efficacy of Spirulina platensis against collagen-induced arthritis in rats. Inflammopharmacology. 2009 Jun;17(3):181-90. doi: 10.1007/s10787-009-0004-1. Epub 2009 Apr 24. |
| 7732699 | Background | Dillon JC, Phuc AP, Dubacq JP. Nutritional value of the alga Spirulina. World Rev Nutr Diet. 1995;77:32-46. doi: 10.1159/000424464. No abstract available. |
| 26251635 | Background | Castel LD, Wallston KA, Saville BR, Alvarez JR, Shields BD, Feurer ID, Cella D. Validity and reliability of the Patient-Reported Arthralgia Inventory: validation of a newly-developed survey instrument to measure arthralgia. Patient Relat Outcome Meas. 2015 Jul 28;6:205-14. doi: 10.2147/PROM.S47997. eCollection 2015. |
| 33876393 | Background | Magni A, Agostoni P, Bonezzi C, Massazza G, Mene P, Savarino V, Fornasari D. Management of Osteoarthritis: Expert Opinion on NSAIDs. Pain Ther. 2021 Dec;10(2):783-808. doi: 10.1007/s40122-021-00260-1. Epub 2021 Apr 19. |
| 36712528 | Background | Suhail M, Rehan M, Tarique M, Tabrez S, Husain A, Zughaibi TA. Targeting a transcription factor NF-kappaB by green tea catechins using in silico and in vitro studies in pancreatic cancer. Front Nutr. 2023 Jan 11;9:1078642. doi: 10.3389/fnut.2022.1078642. eCollection 2022. |
| 20447316 | Background | Ahmed S. Green tea polyphenol epigallocatechin 3-gallate in arthritis: progress and promise. Arthritis Res Ther. 2010;12(2):208. doi: 10.1186/ar2982. Epub 2010 Apr 28. |
| 10665827 | Background | Zaratin P, Angelici O, Clarke GD, Schmid G, Raiteri M, Carita F, Bonanno G. NK3 receptor blockade prevents hyperalgesia and the associated spinal cord substance P release in monoarthritic rats. Neuropharmacology. 2000;39(1):141-9. doi: 10.1016/s0028-3908(99)00087-8. |
| Background | Barbalho S. M., Goulart R. D. A, Buglio D. S., Araujo A. C., Guiguer E. L. The possible role of green tea on osteoarthritis: a narrative report. Longhua Chin Med 2020;3:11. |
| 39500125 | Background | Strand NH, D'Souza RS, Gomez DA, Whitney MA, Attanti S, Anderson MA, Moeschler SM, Chadwick AL, Maloney JA. Pain during menopause. Maturitas. 2025 Jan;191:108135. doi: 10.1016/j.maturitas.2024.108135. Epub 2024 Oct 31. |
| 20537472 | Background | Magliano M. Menopausal arthralgia: Fact or fiction. Maturitas. 2010 Sep;67(1):29-33. doi: 10.1016/j.maturitas.2010.04.009. |
| 37127408 | Background | Blumer J. Arthralgia of menopause - A retrospective review. Post Reprod Health. 2023 Jun;29(2):95-97. doi: 10.1177/20533691231172565. Epub 2023 May 1. |
| Corticosteroid Adverse Effects | View source |
| Green tea polyphenol epigallocatechin 3-gallate in arthritis: progress and promise. | View source |
| Measurement properties of the musculoskeletal health questionnaire (MSK-HQ): a between country comparison | View source |
| The potential application of Spirulina (Arthrospora) as a nutritional and therapeutic supplement in health management | View source |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |