The Effect of Picricum Acidum and Phosphoricum Acidum Homaccord on Perceived Levels of Anxiety in University Students

May 16, 2016 updated by: Dr J. Pellow, University of Johannesburg

Increased levels of stress and anxiety are experienced by many students. Stress can have a negative influence on academic outcome and performance, as well as on the student's mental health. Conventional treatment options for anxiety include counseling, as well as anxiolytics and antidepressants, which may have various adverse effects. Picricum acidum and Phosphoricum acidum are homeopathic remedies that may be helpful in alleviating anxiety in students; however there has been no research done to date to show their efficacy for this condition.

The aim of this study is to determine the effect of Picricum acidum and Phosphoricum acidum Homaccord on perceived levels of anxiety in university students, by means of the State-Trait-Anxiety-Inventory and Anxiety Symptom Score Card.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be a randomized, double-blind, placebo-controlled study, conducted over a two-week period at the University of Johannesburg (UJ) Health Clinic, Doornfontein Campus. Thirty university students, aged between 18 and 45 years, will be recruited into the study by means of advertisements placed on the campus with relevant permission given. Participants will attend an initial consultation and will be requested to sign a Participant Information and Consent form, complete the Participant Information Sheet, and a Remedy Symptom Questionnaire to determine inclusion into the study. Participants' vital signs will be measured. Participants will then receive a 16ml vial of either the Picricum acidum and Phosphoricum acidum Homaccord pillules, or a placebo (unmedicated sucrose pillules), which will be randomized and dispensed by the UJ Homeopathic Dispenser. Participants will be requested to take 5 pillules in a daily dose for 14 days, commencing 21 days before and ceasing 7 days prior to the start of examinations. The State-Trait-Anxiety-Inventory (STAI) and the Anxiety Symptom Score Card will be completed 21 days prior to the first academic examination, as well as on the last day of taking the medication. Data will be collected and analyzed by Statkon, using the Shapiro-Wilk test, the Mann-Whitney test and the Wilcoxon signed ranks test.

The outcome of this research may show that the Homeopathic Picricum acidum and Phosphoricum acidum Homaccord has a positive effect in alleviating anxiety in university students, allowing for further studies in the field.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2028
        • University of Johannesburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, between the ages of 18 and 45;
  • Registered University students;
  • Participants must experience anxiety symptoms, manifesting six or more of the following criteria: muscle tension, increased perspiration, rapid heartbeat, headaches, stomach aches, agitation, irritability, hostility, fear, extreme sensitivity to rejection or failure, motor restlessness, procrastination, excessive worry, concentration difficulties, attention difficulties and memory problems;
  • Participants must be writing a major examination one week after the study ends;
  • Participants must have six or more of the symptoms relating to Picricum acidum and Phosphoricum acidum (Appendix D); and
  • Participants must have a cell phone and on-line computer access.

Exclusion Criteria:

• Have been diagnosed with: A psychological anxiety disorder, Psychiatric disorders (Bipolar disorder, Depression), Attention Deficit Hyperactivity Disorder and Epilepsy.

  • Are taking any chronic medication for anxiety or mood stabilizing
  • Are pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sucrose pillules
Unmedicated sucrose pillules will be taken once daily, in the morning, 30 minutes after breakfast, for 14 days, up to 7 days before the first academic examination.
Other: Sucrose pillules
Unmedicated sucrose pillules
Other Names:
  • Saccharum officinale
Experimental: Homeopathic homaccord
Sucrose pillules medicated with Picricum acidum and Phosphoricum acidum in potencies of 6CH, 30CH and 200CH. Pillules will be taken once daily, in the morning, 30 minutes after breakfast, for 14 days, up to 7 days before the first academic examination.
Other: Homeopathic homaccord
Sucrose pillules medicated with Picricum acidum and Phosphoricum acidum in potencies of 6CH, 30CH and 200CH.
Other Names:
  • Picricum acidum and Phosphoricum acidum homaccord

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait-Anxiety-Inventory
Time Frame: 14 days
The State-Trait-Anxiety-Inventory is an established, acceptably reliable, validated and commonly utilized tool for measuring an individual's level of anxiety.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Symptom Score Card
Time Frame: 14 days
The Anxiety Symptom Score Card is based on a 5-point grading scale and is designed to monitor anxiety-related symptoms.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Johannesburg

Investigators

  • Study Director: Janice Pellow, M.Tech Hom, University of Johannesburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 16, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KaronWillson200731900
  • AEC44-01-2013 (Other Identifier: University of Johannesburg)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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