Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Efficacy of Viburnum Opulus 3X in the Treatment of Primary Dysmenorrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02467543
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Dr J. Pellow, University of Johannesburg

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Dysmenorrhea Other: 20% Ethanol Other: Viburnum opulus 3X Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Viburnum Opulus 3X in the Treatment of Primary Dysmenorrhea
Study Start Date : February 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
Placebo Comparator: 20% Ethanol
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.
Other: 20% Ethanol
Unmedicated 20% Ethanol

Experimental: Viburnum opulus 3X
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.
Other: Viburnum opulus 3X
Viburnum opulus 3X in a vehicle of 20% ethanol.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pain as measured by the Visual Analogue Scale (VAS) [ Time Frame: 3 months ]
    The scale (VAS) is a validated and established tool used clinically to assess pain levels.

  2. Patient satisfaction as measured by the 5-Point Treatment Satisfaction Scale [ Time Frame: 1 day ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females between 18-35 years.
  • Have a history of painful menstruation.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467543


Locations
Layout table for location information
South Africa
University of Johannesburg
Johannesburg, Gauteng, South Africa, 2028
Sponsors and Collaborators
University of Johannesburg
Investigators
Layout table for investigator information
Study Director: Elizabeth Solomon, D.TechHom University of Johannesburg
Layout table for additonal information
Responsible Party: Dr J. Pellow, Dr Janice Pellow, University of Johannesburg
ClinicalTrials.gov Identifier: NCT02467543    
Other Study ID Numbers: ZuleikaSaem200819247
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Keywords provided by Dr J. Pellow, University of Johannesburg:
Primary dysmenorrhea
Viburnum opulus 3X
Homoeopathic
Additional relevant MeSH terms:
Layout table for MeSH terms
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs