DysmenorrheaPhase 2NCT02467543
The Efficacy of Viburnum Opulus 3X in the Treatment of Primary Dysmenorrhea
A Phase 2 study testing 20% Ethanol and Viburnum opulus 3X in people with Dysmenorrhea, run by University of Johannesburg at 1 site in South Africa.
Trial summary
Dysmenorrhea (painful menstruation) is a common gynaecological disorder that is prevalent in more than 50% of women during their reproductive years. Primary dysmenorrhea describes cyclic uterine pain without any identifiable or underlying causes. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- 20% Ethanol and Viburnum opulus 3X
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Africa
- Study dates
- Feb 2015to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females between 18-35 years.
- Have a history of painful menstruation.
Who cannot join
- Are on any form of hormonal contraceptives.
- Have intra uterine contraceptive devices.
- Have prediagnosed endometriosis, chronic pelvic inflammatory disease, uterine fibroids, polycystic ovarian syndrome or other known causes of secondary dysmenorrhea.
- Suffers from any serious chronic disease.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Johannesburg
Johannesburg, Gauteng, 2028
About this study
Dysmenorrhea (painful menstruation) is a common gynaecological disorder that is prevalent in more than 50% of women during their reproductive years. Primary dysmenorrhea describes cyclic uterine pain without any identifiable or underlying causes. Menstrual pain results as a consequence of endometrial ischemia, high levels of prostaglandins and other inflammatory mediators. Conventional treatment for primary dysmenorrhea consists of non-steroidal anti-inflammatory drugs and oral contraceptives, which may have adverse effects. Viburnum opulus (Cramp bark) is a homoeopathic remedy well indicated for the treatment of dysmenorrhea. While there are studies using Viburnum opulus in its herbal form, there is no research assessing its efficacy in the homoeopathic form.
The aim of this study is to determine the efficacy of Viburnum opulus 3X in the treatment of primary dysmenorrhea as measured with the modified Short Form McGill pain questionnaire (SF-MPQ-2) and visual analogue scale (VAS) respectively.
Read the detailed description
This will be a double blind placebo controlled study, involving 30 female participants. The study will run for 3 months, over 3 menstrual cycles and shall be determined by the length of each participant menstrual cycle. The participants will be assessed over 3 menstrual events. Consultations will take place in a private setting at the Homoeopathic Health Centre at the Doornfontein campus, under the supervision of a registered homoeopath.
Participants will be recruited by advertisements placed at the University of Johannesburg Health Centre located on the Doornfontein campus, with the relevant permission obtained.
The researcher will explain the study to each participant as well as provide each participant with a consent form to sign, before they may take part in the study. Participants will be screened and a general physical examination will be conducted to asses each participant's general wellbeing. Each participant will be issued with a modified Short Form McGill questionnaire and the Visual Analogue Scale to complete. Participants will be instructed to complete the forms when they begin to experience the pain and cramping. No medication will be given at the initial consultation.
During the second follow-up consultation the participants will return their completed forms given to them at the initial consultation. Each participant will be issued with a 50 ml bottle of the homoeopathic remedy or placebo and new forms (SF-MPQ-2 and VAS) to complete. Participants will be advised to take 10 drops of the remedy three times a day starting when they experience pain and cramping. The forms will additionally need to be completed during this time. The participants will be advised to stop the homoeopathic remedy when their pain and cramping has ceased. This process will be repeated at both the third and fourth consultations.
During the final consultation participants will return the last forms to the researcher. The participants will measure their subjective satisfaction of the medicine on their pain by completing the five point treatment satisfaction scale.
The data will be statistically analysed by the researcher with the aid of a statistician. This will be done using the non-parametric Friedmann test (to measure the differences within both groups) and the Mann-Whitney test (to measure the differences between the groups) as well as the repeated measures ANOVA. These tests will evaluate the change of severity of symptoms over time.
The possible benefits for those participating in the study may include an improvement in their symptoms of primary dysmenorrhea. This study will contribute to the medical knowledge and efficacy of the clinical management of primary dysmenorrhea.
- Conditions
- Dysmenorrhea
- Being tested
- 20% Ethanol, Viburnum opulus 3X
- Keywords
- Primary dysmenorrhea, Viburnum opulus 3X, Homoeopathic
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% EthanolOther
Unmedicated 20% Ethanol
Viburnum opulus 3XOther
Viburnum opulus 3X in a vehicle of 20% ethanol.
| Study group | Role | What they receive |
|---|---|---|
| 20% Ethanol | Placebo comparator | 20% ethanol containing no active ingredients. Ten drops will be taken three times daily when the pain and cramping of dysmenorrhea start, and should be stopped when the pain and cramping have ceased. Receives: Other: 20% Ethanol |
| Viburnum opulus 3X | Experimental | Viburnum opulus 3X in a vehicle of 20% ethanol. Ten drops will be taken three times daily when the pain and cramping of dysmenorrhea start, and should be stopped when the pain and cramping have ceased. Receives: Other: Viburnum opulus 3X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as measured by the Short Form McGill Pain Questionnaire (SF-MPQ-2)
The SF-MPQ-2 is a highly reliable and sensitive instrument used to asses and measure pain levels.
Measured: 3 months
Secondary outcomes (2)
Pain as measured by the Visual Analogue Scale (VAS)
The scale (VAS) is a validated and established tool used clinically to assess pain levels.
Measured: 3 months
Patient satisfaction as measured by the 5-Point Treatment Satisfaction Scale
The 5-Point Treatment Satisfaction Scale is a reliable tool to assess patient satisfaction with the treatment provided. This will be conducted once at the final consultation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Johannesburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr J. Pellow, University of Johannesburg
- Investigators
- Elizabeth Solomon, D.TechHom, Study director, University of Johannesburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467543
- Sponsor's protocol ID
- ZuleikaSaem200819247
- Status last verified
- May 2016
- First submitted
- 5 Jun 2015
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Viburnum Opulus 3X in the Treatment of Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT02467543
- Acronym / sponsor ID
- ZuleikaSaem200819247
- Conditions
- Dysmenorrhea
- Keywords
- Primary dysmenorrhea, Viburnum opulus 3X, Homoeopathic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of JohannesburgUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dysmenorrhea (painful menstruation) is a common gynaecological disorder that is prevalent in more than 50% of women during their reproductive years. Primary dysmenorrhea describes cyclic uterine pain without any identifiable or underlying causes. Menstrual pain results as a consequence of endometrial ischemia, high levels of prostaglandins and other inflammatory mediators. Conventional treatment for primary dysmenorrhea consists of non-steroidal anti-inflammatory drugs and oral contraceptives, which may have adverse effects. Viburnum opulus (Cramp bark) is a homoeopathic remedy well indicated for the treatment of dysmenorrhea. While there are studies using Viburnum opulus in its herbal form, there is no research assessing its efficacy in the homoeopathic form.
The aim of this study is to determine the efficacy of Viburnum opulus 3X in the treatment of primary dysmenorrhea as measured with the modified Short Form McGill pain questionnaire (SF-MPQ-2) and visual analogue scale (VAS) respectively.
Detailed description
This will be a double blind placebo controlled study, involving 30 female participants. The study will run for 3 months, over 3 menstrual cycles and shall be determined by the length of each participant menstrual cycle. The participants will be assessed over 3 menstrual events. Consultations will take place in a private setting at the Homoeopathic Health Centre at the Doornfontein campus, under the supervision of a registered homoeopath.
Participants will be recruited by advertisements placed at the University of Johannesburg Health Centre located on the Doornfontein campus, with the relevant permission obtained.
The researcher will explain the study to each participant as well as provide each participant with a consent form to sign, before they may take part in the study. Participants will be screened and a general physical examination will be conducted to asses each participant's general wellbeing. Each participant will be issued with a modified Short Form McGill questionnaire and the Visual Analogue Scale to complete. Participants will be instructed to complete the forms when they begin to experience the pain and cramping. No medication will be given at the initial consultation.
During the second follow-up consultation the participants will return their completed forms given to them at the initial consultation. Each participant will be issued with a 50 ml bottle of the homoeopathic remedy or placebo and new forms (SF-MPQ-2 and VAS) to complete. Participants will be advised to take 10 drops of the remedy three times a day starting when they experience pain and cramping. The forms will additionally need to be completed during this time. The participants will be advised to stop the homoeopathic remedy when their pain and cramping has ceased. This process will be repeated at both the third and fourth consultations.
During the final consultation participants will return the last forms to the researcher. The participants will measure their subjective satisfaction of the medicine on their pain by completing the five point treatment satisfaction scale.
The data will be statistically analysed by the researcher with the aid of a statistician. This will be done using the non-parametric Friedmann test (to measure the differences within both groups) and the Mann-Whitney test (to measure the differences between the groups) as well as the repeated measures ANOVA. These tests will evaluate the change of severity of symptoms over time.
The possible benefits for those participating in the study may include an improvement in their symptoms of primary dysmenorrhea. This study will contribute to the medical knowledge and efficacy of the clinical management of primary dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20% Ethanol | Placebo comparator | Other: 20% Ethanol20% ethanol containing no active ingredients. Ten drops will be taken three times daily when the pain and cramping of dysmenorrhea start, and should be stopped when the pain and cramping have ceased. |
| Viburnum opulus 3X | Experimental | Other: Viburnum opulus 3XViburnum opulus 3X in a vehicle of 20% ethanol. Ten drops will be taken three times daily when the pain and cramping of dysmenorrhea start, and should be stopped when the pain and cramping have ceased. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females between 18-35 years.
- Have a history of painful menstruation.
Key exclusion criteria (4 listed)
- Are on any form of hormonal contraceptives.
- Have intra uterine contraceptive devices.
- Have prediagnosed endometriosis, chronic pelvic inflammatory disease, uterine fibroids, polycystic ovarian syndrome or other known causes of secondary dysmenorrhea.
- Suffers from any serious chronic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20% EthanolUnmedicated 20% Ethanol | Other | 20% Ethanol |
| Viburnum opulus 3XViburnum opulus 3X in a vehicle of 20% ethanol. | Other | Viburnum opulus 3X |
Primary outcome
Pain as measured by the Short Form McGill Pain Questionnaire (SF-MPQ-2)
Time frame: 3 months
The SF-MPQ-2 is a highly reliable and sensitive instrument used to asses and measure pain levels.
2 secondary outcomes
Pain as measured by the Visual Analogue Scale (VAS)
Time frame: 3 months
Patient satisfaction as measured by the 5-Point Treatment Satisfaction Scale
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Solomon, D.TechHom study director
University of Johannesburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 20% Ethanol and Viburnum opulus 3X in people with Dysmenorrhea, run by University of Johannesburg at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as measured by the Short Form McGill Pain Questionnaire (SF-MPQ-2) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.