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

Primary Purpose

Anxiety

Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
Sucrose pillules
Homeopathic homaccord
Sponsored by
University of Johannesburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring anxiety, students, examinations, Homeopathy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Johannesburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Sucrose pillules

Homeopathic homaccord

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

State-Trait-Anxiety-Inventory
The State-Trait-Anxiety-Inventory is an established, acceptably reliable, validated and commonly utilized tool for measuring an individual's level of anxiety.

Secondary Outcome Measures

Anxiety Symptom Score Card
The Anxiety Symptom Score Card is based on a 5-point grading scale and is designed to monitor anxiety-related symptoms.

Full Information

First Posted
August 4, 2014
Last Updated
May 16, 2016
Sponsor
University of Johannesburg
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1. Study Identification

Unique Protocol Identification Number
NCT02208726
Brief Title
The Effect of Picricum Acidum and Phosphoricum Acidum Homaccord on Perceived Levels of Anxiety in University Students
Official Title
The Effect of Picricum Acidum and Phosphoricum Acidum Homaccord on Perceived Levels of Anxiety in University Students
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
August 2014 (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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety, students, examinations, Homeopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sucrose pillules
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Homeopathic homaccord
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sucrose pillules
Other Intervention Name(s)
Saccharum officinale
Intervention Description
Unmedicated sucrose pillules
Intervention Type
Other
Intervention Name(s)
Homeopathic homaccord
Other Intervention Name(s)
Picricum acidum and Phosphoricum acidum homaccord
Intervention Description
Sucrose pillules medicated with Picricum acidum and Phosphoricum acidum in potencies of 6CH, 30CH and 200CH.
Primary Outcome Measure Information:
Title
State-Trait-Anxiety-Inventory
Description
The State-Trait-Anxiety-Inventory is an established, acceptably reliable, validated and commonly utilized tool for measuring an individual's level of anxiety.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Anxiety Symptom Score Card
Description
The Anxiety Symptom Score Card is based on a 5-point grading scale and is designed to monitor anxiety-related symptoms.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Pellow, M.Tech Hom
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

Learn more about this trial

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

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