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

• ClinicalTrials.gov Identifier: NCT02467543
• Recruitment Status: Completed
• First Posted: June 10, 2015
• Last Update Posted: May 19, 2016
• Sponsor: University of Johannesburg
• Information provided by (Responsible Party): Dr J. Pellow, University of Johannesburg

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

South Africa

University of Johannesburg

Johannesburg, Gauteng, South Africa, 2028

Sponsors and Collaborators

University of Johannesburg

Investigators

• Study Director: Elizabeth Solomon, D.TechHom; University of Johannesburg

More 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
• 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:

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