Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Trial · NCT07898670
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in the 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) score | Baseline and end of the initial randomized phase at 12 weeks (up to 16 weeks if extended to align with the menstrual cycle). | Between-group difference in change from baseline to the end of the initial randomized phase in the SF-36 Mental Component Summary (MCS) score, comparing ashwagandha with placebo. The MCS assesses mental health-related quality of life and is calculated using a standardized, norm-based scoring algorithm, with a reference population mean of 50 and a standard deviation of 10. Higher scores indicate better mental health-related quality of life. |
| Secondary | Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) score | Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle). | Between-group difference in change from baseline to the end of the initial randomized phase in the SF-36 Physical Component Summary (PCS) score, comparing ashwagandha with placebo. The PCS assesses physical health-related quality of life and is calculated using a standardized, norm-based scoring algorithm, with a reference population mean of 50 and a standard deviation of 10. Higher scores indicate better physical health-related quality of life. |
| Secondary | Change in 36-Item Short Form Health Survey (SF-36) domain scores | Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle). | Between-group differences in change from baseline to the end of the initial randomized phase in the eight domains of the 36-Item Short Form Health Survey (SF-36), comparing ashwagandha with placebo: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Each domain is scored separately on a scale from 0 to 100, with higher scores indicating better health-related quality of life. |
| Secondary | Change in Endometriosis Health Profile-30 global score | Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle). | Between-group difference in change from baseline to the end of the initial randomized phase in endometriosis-related quality of life, assessed using the Endometriosis Health Profile-30 (EHP-30) global score, comparing ashwagandha with placebo. Scores range from 0 to 100, with lower scores indicating better endometriosis-related quality of life. |
| Secondary | Change in perceived stress | Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle). | Between-group difference in change from baseline to the end of the initial randomized phase in perceived stress, assessed using the 10-item Perceived Stress Scale (PSS-10), comparing ashwagandha with placebo. The total score ranges from 0 to 40, with higher scores indicating greater perceived stress. |
| Secondary | Participant-reported pain-management strategies and pain medication use | Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle). | Comparison between the ashwagandha and placebo groups of participant-reported pain-management strategies, including total pain medication (name, number, dosage) use during the menstrual cycle. |
| Secondary | Change in participant-reported dyspareunia | Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle). | Between-group difference in change from baseline to the end of the initial randomized phase in participant-reported pain during sexual intercourse (dyspareunia), comparing ashwagandha with placebo. Pain intensity is assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity. |
| Secondary | Within-person change in the 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) during the open-label extension | Start of the open-label extension to its completion 12 weeks later (approximately study Week 12-24, or Week 16-28 if the initial phase is extended). | Within-person change in the SF-36 Mental Component Summary (MCS) score from the start to the end of the open-label extension, during which participants receive ashwagandha. The MCS assesses mental health-related quality of life and is calculated using a standardized, norm-based scoring algorithm, with a reference population mean of 50 and a standard deviation of 10. Higher scores indicate better mental health-related quality of life. |
| Secondary | Within-person change in the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS ) during the open-label extension | Start of the open-label extension to its completion 12 weeks later (approximately study Week 12-24, or Week 16-28 if the initial phase is extended). | Within-person change in the SF-36 Physical Component Summary (PCS) score from the start to the end of the open-label extension, during which participants receive ashwagandha. The PCS assesses physical health-related quality of life and is calculated using a standardized, norm-based scoring algorithm, with a reference population mean of 50 and a standard deviation of 10. Higher scores indicate better physical health-related quality of life. |
| Secondary | Within-person change in the Endometriosis Health Profile-30 (EHP-30) during the open-label extension | Start of the open-label extension to its completion 12 weeks later (approximately study Week 12-24, or Week 16-28 if the initial phase is extended). | Within-person change in the Endometriosis Health Profile-30 (EHP-30) global score from the start to the end of the open-label extension, during which participants receive ashwagandha. The EHP-30 assesses endometriosis-related quality of life. Scores range from 0 to 100, with lower scores indicating better endometriosis-related quality of life. |
| Secondary | Within-person change in the 10-item Perceived Stress Scale (PSS-10) during the open-label extension | Start of the open-label extension to its completion 12 weeks later (approximately study Week 12-24, or Week 16-28 if the initial phase is extended). | Within-person change in the PSS-10 total score from the start to the end of the open-label extension, during which participants receive ashwagandha. The PSS-10 assesses perceived stress. The total score ranges from 0 to 40, with higher scores indicating greater perceived stress. |
| Secondary | Tolerability (Occurrence of clinical adverse events and laboratory abnormalities) | From the first study dose through approximately four weeks after the last dose, up to approximately 32 weeks. | Number of participants experiencing clinical adverse events, with events summarized by frequency and severity; clinically relevant laboratory abnormalities, assessed through scheduled safety blood tests. |
| Other | Change in high-sensitivity C-reactive protein | Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended). | Exploratory comparison between the ashwagandha and placebo groups of change from baseline in blood high-sensitivity C-reactive protein (hs-CRP), a marker of systemic inflammation. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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