NCT02467543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

10 months

First QC Date

June 5, 2015

Last Update Submit

May 18, 2016

Conditions

Dysmenorrhea

Keywords

Primary dysmenorrheaViburnum opulus 3XHomoeopathic

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (2)

  • Pain as measured by the Visual Analogue Scale (VAS)

    3 months

  • Patient satisfaction as measured by the 5-Point Treatment Satisfaction Scale

    1 day

Study Arms (2)

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.

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.

Other: Viburnum opulus 3X

Interventions

20% EthanolOTHER

Unmedicated 20% Ethanol

20% Ethanol
Viburnum opulus 3XOTHER

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

Viburnum opulus 3X

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Johannesburg

Johannesburg, Gauteng, 2028, South Africa

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Elizabeth Solomon, D.TechHom

    University of Johannesburg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Janice Pellow

Study Record Dates

First Submitted

June 5, 2015

First Posted

June 10, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations

ZA(1)