The Efficacy of Individualised Homeopathic Treatment on Constipation

NCT02411175 | Completed Phase 2 DMC

• 1 other identifier: FarhanaNakhooda201007840
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

Constipation; Homeopathy

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Weeks

Secondary Outcomes (2)

• Bristol Stool Form Scale

  6 Weeks

• Means of case notes, recorded on homeopathic Case Taking Form

  Every 2 weeks for 6 weeks

Study Arms (1)

20% Ethanol

EXPERIMENTAL

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.

Other: Individualised Homeopathic Remedy; Drug: 20% ethanol

Interventions

Individualised Homeopathic Remedy OTHER

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.

Also known as: Similimum

20% Ethanol

20% ethanol DRUG

20% Ethanol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Johannesburg: lead

Study Sites (1)

University of Johannesburg

Johannesburg, Gauteng, 2028, South Africa

Location

MeSH Terms

Conditions

Constipation

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Elizabeth Solomon, D.TechHom

  University of Johannesburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr J. Pellow

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 8, 2015
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 19, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)