NCT02208726

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_2 anxiety

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2 anxiety

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

September 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

August 4, 2014

Last Update Submit

May 16, 2016

Conditions

Anxiety

Keywords

anxietystudentsexaminationsHomeopathy

Outcome Measures

Primary Outcomes (1)

  • 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.

    14 days

Secondary Outcomes (1)

  • Anxiety Symptom Score Card

    14 days

Study Arms (2)

Sucrose pillules

PLACEBO COMPARATOR

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

Homeopathic homaccord

EXPERIMENTAL

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

Interventions

Sucrose pillulesOTHER

Unmedicated sucrose pillules

Also known as: Saccharum officinale
Sucrose pillules
Homeopathic homaccordOTHER

Sucrose pillules medicated with Picricum acidum and Phosphoricum acidum in potencies of 6CH, 30CH and 200CH.

Also known as: Picricum acidum and Phosphoricum acidum homaccord
Homeopathic homaccord

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Johannesburg

Johannesburg, Gauteng, 2028, South Africa

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Janice Pellow, M.Tech Hom

    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

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 5, 2014

Study Start

September 1, 2013

Primary Completion

November 1, 2013

Study Completion

August 1, 2014

Last Updated

May 17, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)