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The Efficacy of Individualised Homeopathic Treatment on Constipation

Primary Purpose

Constipation

Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
Individualised Homeopathic Remedy
20% ethanol
Sponsored by
University of Johannesburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Constipation, Homeopathy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between ages 18-50 years,
  • meet the Rome II criteria for constipation which lists:
  • have a bowel evacuation for 3 or less times in a week, for the last 3 months OR
  • have to strain, have hardened stool, or have incomplete bowel evacuation for at least 25% of the time, for the last 3 months.

Exclusion Criteria:

  • People currently on treatment for their constipation,
  • who have used laxatives more than three times in the past month,
  • are on medications which have constipation as a side effect,
  • with pre-diagnosed colon cancer, irritable bowel syndrome- constipation dominant, spastic colon or diverticulitis, and those who had a stroke, and,
  • pregnant females.

Sites / Locations

  • University of Johannesburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

20% Ethanol

Arm Description

20% ethanol will be medicated with the individualised homeopathic remedy as determined by the researcher and administered as drops. The potency, dose and frequency of the medicated 20% ethanol drops will be determined for each prescription, in accordance with the laws that govern homeopathic prescribing.

Outcomes

Primary Outcome Measures

Bowel Function Diary (Adapted)
The Bowel Function Diary is a is a daily record of factors relating to defecation. For this study only two of its items will be monitored- the number of bowel movements and the associated ease or difficulty of defecation. The diary has been demonstrated to have an acceptable test-retest reliability and supported validity for each item, with a p-value of <0.001.

Secondary Outcome Measures

Bristol Stool Form Scale
The Bristol Stool Form Scale is a 7 score visual scale to measure stool consistency. It has been proved to be a reliable and valid measure, and can be effectively used with participants over the age of 8 for research purposes.
Means of case notes, recorded on homeopathic Case Taking Form
Qualitative data will be collected by means of case notes, recorded on homeopathic Case Taking Forms, which will be taken at weeks 0, 2, 4 and 6.

Full Information

First Posted
April 3, 2015
Last Updated
May 18, 2016
Sponsor
University of Johannesburg
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1. Study Identification

Unique Protocol Identification Number
NCT02411175
Brief Title
The Efficacy of Individualised Homeopathic Treatment on Constipation
Official Title
The Efficacy of Individualised Homeopathic Treatment on Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Johannesburg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Constipation is an umbrella term encompassing either infrequent bowel movements, difficult evacuation of stool, hard stool or a sensation of incomplete defecation. It affects 10-15% of the global population. Constipation may negatively impact physical health, moods and social life. There exists a 50% dissatisfaction with traditional approach of laxative use. Conventional laxatives only offer a temporary solution and may cause dependency. Side-effects of conventional laxatives include nausea, vomiting, flatulence, diarrhoea, abdominal pain, electrolyte imbalance and skin eruptions. Homeopathy is a potential treatment option for constipation, however further research is needed in this regard. The aim of this study is to determine the efficacy of individualised homeopathic treatment on constipation using case studies, an adapted Bowel Function Diary and the Bristol Stool Form Scale.
Detailed Description
The research study will be of an embedded mixed method case study design and take place over a 6 week period at the University of Johannesburg Doornfontein Health Centre. Ten participants of either gender, between the ages of 18 to 50 years will be recruited using advertisements placed at the Doornfontein campus Health Centre.Those interested in participating in the research will be requested to attend an initial meeting in which they will receive a Participant Information Form and be requested to sign a Consent Form. Participants meeting the inclusion criteria will be recruited into the study and a Selection Questionnaire confirming their constipation status will be completed with the help of the researcher. The researcher will then perform a full case taking and relevant physical examination of the participant, the details of which will be recorded on a homeopathic Case Taking Form, as designed by the researcher. The characteristic details of the case will then be identified and analysed using using the Mercurius software Repertory. The homeopathic Materia Medica will be referred to in order to confirm the remedy which best suits the presenting symptomology of the participant. The repertorisation and remedy selection will be conducted under the supervision of a qualified homeopath. The potency, dose and frequency of the selected remedy will be determined according to the laws that govern individualised homeopathic prescribing. The remedy will be administered along with an explanation and demonstration on how to take the remedy. A set of written instructions will be provided for the participant in the form of a Patient Information Leaflet. The participant will be requested to monitor each defecation session and a Bowel Function Diary will be used to record the frequency of defecation, the stool form and the level of difficulty on passing a stool. Participants will return for three follow up consultations at 2 week intervals. If dramatic changes occur in the participant, they will be requested to contact the researcher, who will adjust the treatment accordingly. At each follow up consultation, the participant's case will be re-evaluated with special attention made to changes in symptoms or the appearance of new symptoms, the details of which will be recorded on the Case Follow Up Form, as designed by the researcher. A remedy will be prescribed in the same manner as the initial consultation. The prescription may be repeated or altered in accordance with the participant's presenting symptoms and response to the previous prescription. The laws that govern individualised homeopathic prescribing will be used at all times in determining a prescription. The qualitative data collected from the case taking forms, will be used by the researcher to write detailed case studies. The quantitative data collected, using the Bowel Function Diary and Bristol Stool Form Scale, will be used to assess the participants' changes in defecation quality and frequency over the course of treatment, the results of which will be represented graphically. This study will contribute to the body of knowledge of the homeopathic treatment of constipation and may provide a foundation for further research on the efficacy of individualised homeopathic treatment of constipation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Constipation, Homeopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20% Ethanol
Arm Type
Experimental
Arm Description
20% ethanol will be medicated with the individualised homeopathic remedy as determined by the researcher and administered as drops. The potency, dose and frequency of the medicated 20% ethanol drops will be determined for each prescription, in accordance with the laws that govern homeopathic prescribing.
Intervention Type
Other
Intervention Name(s)
Individualised Homeopathic Remedy
Other Intervention Name(s)
Similimum
Intervention Description
20% ethanol will be medicated with the Individualised Homeopathic Remedy in the potency determined by the researcher in accordance with the laws that govern individualised homeopathic prescribing. The medicated 20% ethanol will be administered as drops.
Intervention Type
Drug
Intervention Name(s)
20% ethanol
Primary Outcome Measure Information:
Title
Bowel Function Diary (Adapted)
Description
The Bowel Function Diary is a is a daily record of factors relating to defecation. For this study only two of its items will be monitored- the number of bowel movements and the associated ease or difficulty of defecation. The diary has been demonstrated to have an acceptable test-retest reliability and supported validity for each item, with a p-value of <0.001.
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Bristol Stool Form Scale
Description
The Bristol Stool Form Scale is a 7 score visual scale to measure stool consistency. It has been proved to be a reliable and valid measure, and can be effectively used with participants over the age of 8 for research purposes.
Time Frame
6 Weeks
Title
Means of case notes, recorded on homeopathic Case Taking Form
Description
Qualitative data will be collected by means of case notes, recorded on homeopathic Case Taking Forms, which will be taken at weeks 0, 2, 4 and 6.
Time Frame
Every 2 weeks for 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between ages 18-50 years, meet the Rome II criteria for constipation which lists: have a bowel evacuation for 3 or less times in a week, for the last 3 months OR have to strain, have hardened stool, or have incomplete bowel evacuation for at least 25% of the time, for the last 3 months. Exclusion Criteria: People currently on treatment for their constipation, who have used laxatives more than three times in the past month, are on medications which have constipation as a side effect, with pre-diagnosed colon cancer, irritable bowel syndrome- constipation dominant, spastic colon or diverticulitis, and those who had a stroke, and, pregnant females.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Solomon, D.TechHom
Organizational Affiliation
University of Johannesburg
Official's Role
Study Director
Facility Information:
Facility Name
University of Johannesburg
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2028
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No

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The Efficacy of Individualised Homeopathic Treatment on Constipation

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