Trial Outcomes & Findings for Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms (NCT NCT05145257)
NCT ID: NCT05145257
Last Updated: 2025-01-01
Results Overview
Survey-based assessment (0-5 scale) of changes in premenstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
Baseline, Month 1, Month 2, Month 3
Results posted on
2025-01-01
Participant Flow
Main recruitment took place between 1/5/2022 - 1/10/2022 when 65 participants were recruited. A further 3 participants were recruited on 01/26/2022.
Participant milestones
| Measure |
Elix Cycle Balance
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Elix Cycle Balance
n=68 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 5.07 • n=68 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=68 Participants
|
|
Survey-based assessment (0-5 scale) of menstrual symptoms
|
4.07 units on a scale
STANDARD_DEVIATION 0.49 • n=68 Participants
|
|
Use of over-the-counter NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms.
|
2.17 Number of painkillers taken per day
STANDARD_DEVIATION 0.16 • n=68 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in premenstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months]
Baseline
|
4.41 score on a scale
Standard Deviation 1.10
|
|
Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months]
Month 1
|
3.48 score on a scale
Standard Deviation 1.18
|
|
Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months]
Month 2
|
3.12 score on a scale
Standard Deviation 1.14
|
|
Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months]
Month 3
|
2.72 score on a scale
Standard Deviation 1.09
|
PRIMARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in menstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Relief From Menstrual Cramps During the Period [Time Frame: Baseline to 3 Months]
Baseline
|
5.00 score on a scale
Standard Deviation 0.92
|
|
Relief From Menstrual Cramps During the Period [Time Frame: Baseline to 3 Months]
Month 1
|
3.95 score on a scale
Standard Deviation 1.31
|
|
Relief From Menstrual Cramps During the Period [Time Frame: Baseline to 3 Months]
Month 2
|
3.30 score on a scale
Standard Deviation 1.24
|
|
Relief From Menstrual Cramps During the Period [Time Frame: Baseline to 3 Months]
Month 3
|
3.02 score on a scale
Standard Deviation 1.30
|
PRIMARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment to assess the change in the number of over-the-counter NSAIDS used from baseline to 12 weeks. Participants were presented with the following options: 1 a day, 2 a day, 3 a day, 4+ a day. A lower score indicates a better outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Reduction in Usage of OTC NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. [Time Frame: Baseline to 3 Months]
Baseline
|
2.05 NSAID tablets per day
Standard Deviation 0.16
|
|
Reduction in Usage of OTC NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. [Time Frame: Baseline to 3 Months]
Month 1
|
1.32 NSAID tablets per day
Standard Deviation 0.06
|
|
Reduction in Usage of OTC NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. [Time Frame: Baseline to 3 Months]
Month 2
|
1.07 NSAID tablets per day
Standard Deviation 0.13
|
|
Reduction in Usage of OTC NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. [Time Frame: Baseline to 3 Months]
Month 3
|
0.86 NSAID tablets per day
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in mood swings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Reduction in Mood Swings. [Time Frame: Baseline to Week 12]
Baseline
|
4.59 score on a scale
Standard Deviation 1.01
|
|
Reduction in Mood Swings. [Time Frame: Baseline to Week 12]
Month 1
|
3.36 score on a scale
Standard Deviation 1.19
|
|
Reduction in Mood Swings. [Time Frame: Baseline to Week 12]
Month 2
|
3.15 score on a scale
Standard Deviation 1.29
|
|
Reduction in Mood Swings. [Time Frame: Baseline to Week 12]
Month 3
|
2.75 score on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in anxiety and depression. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Feelings of Anxiety and Depression. [Time Frame: Baseline to Month 3]
Baseline
|
4.36 score on a scale
Standard Deviation 1.20
|
|
Feelings of Anxiety and Depression. [Time Frame: Baseline to Month 3]
Month 1
|
3.59 score on a scale
Standard Deviation 1.38
|
|
Feelings of Anxiety and Depression. [Time Frame: Baseline to Month 3]
Month 2
|
3.15 score on a scale
Standard Deviation 1.40
|
|
Feelings of Anxiety and Depression. [Time Frame: Baseline to Month 3]
Month 3
|
2.84 score on a scale
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in acne flare ups. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Relief From Acne Flare-ups. [Time Frame: Baseline to Month 3]
Baseline
|
3.74 score on a scale
Standard Deviation 1.41
|
|
Relief From Acne Flare-ups. [Time Frame: Baseline to Month 3]
Month 1
|
3.02 score on a scale
Standard Deviation 1.35
|
|
Relief From Acne Flare-ups. [Time Frame: Baseline to Month 3]
Month 2
|
2.51 score on a scale
Standard Deviation 1.35
|
|
Relief From Acne Flare-ups. [Time Frame: Baseline to Month 3]
Month 3
|
2.33 score on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in headaches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Relief From Headaches. [Time Frame: Baseline to Month 3]
Baseline
|
4.08 score on a scale
Standard Deviation 1.32
|
|
Relief From Headaches. [Time Frame: Baseline to Month 3]
Month 1
|
2.92 score on a scale
Standard Deviation 1.40
|
|
Relief From Headaches. [Time Frame: Baseline to Month 3]
Month 2
|
2.64 score on a scale
Standard Deviation 1.39
|
|
Relief From Headaches. [Time Frame: Baseline to Month 3]
Month 3
|
2.49 score on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in backaches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Relief From Backaches. [Time Frame: Baseline to Month 3]
Baseline
|
4.15 score on a scale
Standard Deviation 1.33
|
|
Relief From Backaches. [Time Frame: Baseline to Month 3]
Month 1
|
3.05 score on a scale
Standard Deviation 1.38
|
|
Relief From Backaches. [Time Frame: Baseline to Month 3]
Month 2
|
2.62 score on a scale
Standard Deviation 1.28
|
|
Relief From Backaches. [Time Frame: Baseline to Month 3]
Month 3
|
2.38 score on a scale
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in body aches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Relief From Body Aches. [Time Frame: Baseline to Month 3]
Baseline
|
3.67 score on a scale
Standard Deviation 1.38
|
|
Relief From Body Aches. [Time Frame: Baseline to Month 3]
Month 1
|
2.44 score on a scale
Standard Deviation 1.31
|
|
Relief From Body Aches. [Time Frame: Baseline to Month 3]
Month 2
|
2.28 score on a scale
Standard Deviation 1.27
|
|
Relief From Body Aches. [Time Frame: Baseline to Month 3]
Month 3
|
2.08 score on a scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in bloating. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Relief From Bloating. [Time Frame: Baseline to Month 3]
Baseline
|
4.21 score on a scale
Standard Deviation 1.22
|
|
Relief From Bloating. [Time Frame: Baseline to Month 3]
Month 1
|
3.21 score on a scale
Standard Deviation 1.21
|
|
Relief From Bloating. [Time Frame: Baseline to Month 3]
Month 2
|
2.87 score on a scale
Standard Deviation 1.29
|
|
Relief From Bloating. [Time Frame: Baseline to Month 3]
Month 3
|
2.51 score on a scale
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in gastrointestinal issues. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Relief From Gastrointestinal Issues. [Time Frame: Baseline to Month 3]
Baseline
|
3.97 score on a scale
Standard Deviation 1.38
|
|
Relief From Gastrointestinal Issues. [Time Frame: Baseline to Month 3]
Month 1
|
3.05 score on a scale
Standard Deviation 1.51
|
|
Relief From Gastrointestinal Issues. [Time Frame: Baseline to Month 3]
Month 2
|
2.74 score on a scale
Standard Deviation 1.25
|
|
Relief From Gastrointestinal Issues. [Time Frame: Baseline to Month 3]
Month 3
|
2.26 score on a scale
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in joint or muscle pain. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Relief From Joint or Muscle Pain. [Time Frame: Baseline to Month 3]
Baseline
|
3.46 score on a scale
Standard Deviation 1.52
|
|
Relief From Joint or Muscle Pain. [Time Frame: Baseline to Month 3]
Month 1
|
2.31 score on a scale
Standard Deviation 1.30
|
|
Relief From Joint or Muscle Pain. [Time Frame: Baseline to Month 3]
Month 2
|
2.16 score on a scale
Standard Deviation 1.05
|
|
Relief From Joint or Muscle Pain. [Time Frame: Baseline to Month 3]
Month 3
|
1.90 score on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in tiredness and fatigue. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Relief From Tiredness or Fatigue. [Time Frame: Baseline to Month 3]
Baseline
|
4.69 score on a scale
Standard Deviation 0.96
|
|
Relief From Tiredness or Fatigue. [Time Frame: Baseline to Month 3]
Month 1
|
3.62 score on a scale
Standard Deviation 1.20
|
|
Relief From Tiredness or Fatigue. [Time Frame: Baseline to Month 3]
Month 2
|
3.26 score on a scale
Standard Deviation 1.39
|
|
Relief From Tiredness or Fatigue. [Time Frame: Baseline to Month 3]
Month 3
|
2.93 score on a scale
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in menstrual symptoms, fatigue, and mood swings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Reduction in Weight Gain Due to Fluid Retention. [Time Frame: Baseline to Month 3]
Baseline
|
3.49 score on a scale
Standard Deviation 1.51
|
|
Reduction in Weight Gain Due to Fluid Retention. [Time Frame: Baseline to Month 3]
Month 1
|
2.66 score on a scale
Standard Deviation 1.40
|
|
Reduction in Weight Gain Due to Fluid Retention. [Time Frame: Baseline to Month 3]
Month 2
|
2.31 score on a scale
Standard Deviation 1.27
|
|
Reduction in Weight Gain Due to Fluid Retention. [Time Frame: Baseline to Month 3]
Month 3
|
2.08 score on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in breast tenderness. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Relief From Breast Tenderness. [Time Frame: Baseline to Month 3]
Month 2
|
2.20 score on a scale
Standard Deviation 1.30
|
|
Relief From Breast Tenderness. [Time Frame: Baseline to Month 3]
Baseline
|
3.30 score on a scale
Standard Deviation 1.41
|
|
Relief From Breast Tenderness. [Time Frame: Baseline to Month 3]
Month 1
|
2.62 score on a scale
Standard Deviation 1.38
|
|
Relief From Breast Tenderness. [Time Frame: Baseline to Month 3]
Month 3
|
1.93 score on a scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 3Survey-based assessment (0-5 scale) of changes in appetite and food cravings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Outcome measures
| Measure |
Elix Cycle Balance
n=61 Participants
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Changes in Appetite and Food Cravings. [Time Frame: Baseline to Month 3]
Baseline
|
3.98 score on a scale
Standard Deviation 1.20
|
|
Changes in Appetite and Food Cravings. [Time Frame: Baseline to Month 3]
Month 1
|
3.03 score on a scale
Standard Deviation 1.31
|
|
Changes in Appetite and Food Cravings. [Time Frame: Baseline to Month 3]
Month 2
|
2.31 score on a scale
Standard Deviation 1.21
|
|
Changes in Appetite and Food Cravings. [Time Frame: Baseline to Month 3]
Month 3
|
2.16 score on a scale
Standard Deviation 1.13
|
Adverse Events
Elix Cycle Balance
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Elix Cycle Balance
n=68 participants at risk
Elix Cycle Balance supplement
Elix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
|
|---|---|
|
Gastrointestinal disorders
Stomach upset
|
1.5%
1/68 • Number of events 1 • Adverse event data were collected for the duration of the trial. Each participant was monitored for the 3 months they took part in the trial.
All participants were monitored for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Headache
|
1.5%
1/68 • Number of events 1 • Adverse event data were collected for the duration of the trial. Each participant was monitored for the 3 months they took part in the trial.
All participants were monitored for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Social circumstances
Personal Issue
|
1.5%
1/68 • Number of events 1 • Adverse event data were collected for the duration of the trial. Each participant was monitored for the 3 months they took part in the trial.
All participants were monitored for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Product Issues
No response
|
5.9%
4/68 • Number of events 4 • Adverse event data were collected for the duration of the trial. Each participant was monitored for the 3 months they took part in the trial.
All participants were monitored for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place