An interventional study of Ashwagandha and placebo capsule in Endometriosis, Quality of Life and Pain, sponsored by Medical University of Vienna. Not yet recruiting at 1 site in Austria. Open to female participants aged 18 Years to 51 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to learn how ashwagandha, a herbal dietary supplement, affects quality of life in women with endometriosis. Researchers will also assess how well participants tolerate it.
The main questions are:
Researchers will compare ashwagandha with a placebo, a look-alike capsule containing no active ingredient. The study will include 90 women. A chance process will assign participants to a group. Each participant has a two-in-three chance of receiving ashwagandha. Neither participants nor researchers assessing the results will know who receives ashwagandha during this phase.
Participants will:
After the first phase, eligible participants may choose to continue for another 12 weeks. Everyone in this optional phase will take ashwagandha and know they are taking it. Researchers will track further changes in quality of life, stress, and side effects.
Participants will continue their usual care for endometriosis. Whether ashwagandha benefits women with endometriosis is not yet known.
Women with endometriosis frequently experience reduced quality of life, increased perceived stress, fatigue, and sleep disturbances. Ashwagandha (Withania somnifera) has been investigated for its effects on stress and well-being in other populations, but its effects in women with endometriosis remain uncertain. This exploratory study evaluates its use as a dietary supplement alongside standard care. The initial randomized, placebo-controlled phase will provide the controlled comparison. Assessments will be aligned with the menstrual cycle where feasible to account for cycle-related fluctuations in participant-reported outcomes. The optional open-label extension will provide descriptive information on longer-term tolerability and within-participant changes. Extension outcomes will be analysed separately according to initial treatment allocation to explore whether changes are maintained in participants initially assigned to ashwagandha and whether changes emerge in those initially assigned to placebo. As there is no placebo comparison during the extension, these findings will be interpreted descriptively. Additional blood samples will be stored for potential future research. Analyses of stored samples will require separate ethics committee approval.
926 studies on the registry are indexed under Endometriosis; 264 are open to participants now.
This study's planned enrollment of 90 is above the median of 65 across 539 interventional studies indexed under Endometriosis.
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Exclusion Criteria:
Participants take a matching placebo orally once daily for 12 weeks. The initial phase may be extended to a maximum of 16 weeks to align assessments with the menstrual cycle. Eligible participants may then enter an optional open-label extension and switch to ashwagandha 300 mg orally once daily for a further 12 weeks.
Drug: placebo capsule
Participants take ashwagandha 300 mg orally once daily for 12 weeks. The initial phase may be extended to a maximum of 16 weeks to align assessments with the menstrual cycle. Eligible participants may then enter an optional open-label extension and continue ashwagandha 300 mg orally once daily for a further 12 weeks.
Dietary Supplement: Ashwagandha
The product is commercially available as the root and leaf extract, SHODEN®, 300 mg per capsule, standardized to at least 30% withanolides.
Matching placebo (capsules containing an inert filler, identical in appearance, taste, and smell to the active study product)
Change from baseline in the 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) score
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.
Time frame: Baseline and end of the initial randomized phase at 12 weeks (up to 16 weeks if extended to align with the menstrual cycle).
Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) score
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.
Time frame: 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).
Change in 36-Item Short Form Health Survey (SF-36) domain scores
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.
Time frame: 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).
Change in Endometriosis Health Profile-30 global score
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.
Time frame: 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).
Change in perceived stress
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.
Time frame: 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).
Participant-reported pain-management strategies and pain medication use
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.
Time frame: 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).
Change in participant-reported dyspareunia
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.
Time frame: 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).
Within-person change in the 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) during the open-label extension
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.
Time frame: 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 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS ) during the open-label extension
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.
Time frame: 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) during the open-label extension
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.
Time frame: 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 10-item Perceived Stress Scale (PSS-10) during the open-label extension
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.
Time frame: 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).
Tolerability (Occurrence of clinical adverse events and laboratory abnormalities)
Number of participants experiencing clinical adverse events, with events summarized by frequency and severity; clinically relevant laboratory abnormalities, assessed through scheduled safety blood tests.
Time frame: From the first study dose through approximately four weeks after the last dose, up to approximately 32 weeks.
Change in high-sensitivity C-reactive protein
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.
Time frame: Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended).
Plan to share: No — There is currently no plan to share individual participant data with researchers outside the study team.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ashwagandha
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