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The Efficacy of Lacticum Acidum Homaccord in the Treatment of Chronic Tension-type Headaches

Primary Purpose

Chronic Tension-type Headaches

Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
Lacticum acidum homaccord
Placebo
Sponsored by
University of Johannesburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Tension-type Headaches focused on measuring Lacticum acidum homaccord, homeopathy, chronic tension-type headaches

Eligibility Criteria

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

Inclusion Criteria:

  • Are male or female participants between the ages of 18 and 45 years;
  • Fit the diagnostic criteria for CTTHs: headache occurring for 15 days a month or more, for a period of more than 3 months a year and lasts for hours or may be continuous. The headache should have at least one of the following characteristics: 1. bilateral location; 2. pressing/tightening (non-pulsating) quality; 3. mild or moderate intensity, 4. aggravated by normal physical activities such as walking or climbing stairs; and at least one of the characteristics in the following categories: 5.1. photophobia, phonophobia or mild nausea, and 5.2. moderate or severe nausea or vomiting ; and
  • Fit eight out of the twelve headache-related symptom criteria for Lacticum acidum .

Exclusion Criteria:

  • Have history of headache or a change in their normal pattern or type of headache over the previous three months;
  • Have had any head, neck or back injury in the previous month;
  • Suffer from rheumatoid arthritis, a suspected tumour or vision problems;
  • Use opioids or analgesics for more than 15 days a month, for more than three months a year;
  • Use chronic medication such as corticosteroids, antidepressants, anti-hypertensives; and / or
  • Are pregnant or breastfeeding.

Sites / Locations

  • UJ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lacticum acidum homaccord

Placebo

Arm Description

Lacticum acidum homaccord 30 mL bottle of medicated sucrose pillules take 5 pillules of the medication in the morning and in the evening for 4 weeks

Unmedicated sucrose pillules, take 5 pillules twice daily for 4 weeks

Outcomes

Primary Outcome Measures

modified Headache Diary and the Headache Disability Inventory.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2014
Last Updated
May 16, 2016
Sponsor
University of Johannesburg
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1. Study Identification

Unique Protocol Identification Number
NCT02138474
Brief Title
The Efficacy of Lacticum Acidum Homaccord in the Treatment of Chronic Tension-type Headaches
Official Title
The Efficacy of Lacticum Acidum Homaccord in the Treatment of Chronic Tension-type Headaches
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 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
Chronic tension-type headaches (CTTHs) affect 30-40% of the population and account for a number of absences from, and decreased performances at, work and school as well as recreational activities. CTTHs typically occur at least 15 times a month or at least every second day, and present as an achy or tight sensation that is felt around the head . The pain may last from 30 minutes to several days and varies in intensity . Conventional treatment is palliative, consisting of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), which may produce adverse effects and analgesic rebound headaches . Lacticum acidum 30CH is a homoeopathic remedy that has been shown to have potential benefits in the treatment of CTTHs . Homaccords are the preparation of one remedy in multiple increasing potencies in a single vehicle . There has been no research done to date on Lacticum acidum Homaccord in the treatment of CTTHs.The aim of this study is to determine the efficacy of Lacticum acidum Homaccord in the treatment of chronic tension-type headaches, using the modified Headache Diary and the Headache Disability Inventory.
Detailed Description
The study will be a four-week, double-blind, placebo-controlled study which will take place at the Homoeopathic Health Centre at the University of Johannesburg (UJ) Doornfontein campus. A randomized sample of 30 male and female participants between the ages of 18 and 45 years who suffer from CTTHs will be recruited. This will be done by means of purposive sampling via advertisements placed on the UJ campuses, with relevant permission given . At the initial consultation (day 0), prospective participants will be requested to sign the Participant Information and Consent Form . They will then complete the Screening Questionnaire to assess their eligibility for participating in the study. Those participants who meet the diagnostic criteria for CTTHs, and whose symptoms match at least eight out of the twelve Lacticum acidum headache related symptoms, will be eligible to participate. All participants will also be requested to complete a Headache Disability Inventory. Participants will be placed into matched pairs according to age and gender and will receive one 30 mL bottle of their medication. On days 1-28 each participant will be requested to complete the Headache Diary at the end of each day and to take 5 pillules of the medication in the morning and in the evening. The first follow-up visit will occur on day 14; here participants will complete the Headache Disability Inventory, the completed headache diaries will be exchanged with new ones, a relevant physical examination including vital signs will be conducted and an additional bottle of medication will be given. The final follow-up visit will occur on day 28, where each participant will complete the Headache Disability Inventory, and a relevant physical examination including vital signs will be recorded. Collected data will be evaluated using frequencies, descriptive tests and cross tabulation, the Shapiro Wilk test, the Independent samples t-test or Mann-Whitney test, and the Friedman and Wilcoxon signed ranks tests. A possible outcome is that Lacticum acidum may have an ameliorating effect on CTTHs and may provide a possible alternative treatment option for this condition, opening up the field for further research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tension-type Headaches
Keywords
Lacticum acidum homaccord, homeopathy, chronic tension-type headaches

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
Lacticum acidum homaccord
Arm Type
Experimental
Arm Description
Lacticum acidum homaccord 30 mL bottle of medicated sucrose pillules take 5 pillules of the medication in the morning and in the evening for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Unmedicated sucrose pillules, take 5 pillules twice daily for 4 weeks
Intervention Type
Other
Intervention Name(s)
Lacticum acidum homaccord
Intervention Description
Homeopathic remedy, made using sucrose pillules
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Unmedicated sucrose pillules
Primary Outcome Measure Information:
Title
modified Headache Diary and the Headache Disability Inventory.
Time Frame
one month

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: Are male or female participants between the ages of 18 and 45 years; Fit the diagnostic criteria for CTTHs: headache occurring for 15 days a month or more, for a period of more than 3 months a year and lasts for hours or may be continuous. The headache should have at least one of the following characteristics: 1. bilateral location; 2. pressing/tightening (non-pulsating) quality; 3. mild or moderate intensity, 4. aggravated by normal physical activities such as walking or climbing stairs; and at least one of the characteristics in the following categories: 5.1. photophobia, phonophobia or mild nausea, and 5.2. moderate or severe nausea or vomiting ; and Fit eight out of the twelve headache-related symptom criteria for Lacticum acidum . Exclusion Criteria: Have history of headache or a change in their normal pattern or type of headache over the previous three months; Have had any head, neck or back injury in the previous month; Suffer from rheumatoid arthritis, a suspected tumour or vision problems; Use opioids or analgesics for more than 15 days a month, for more than three months a year; Use chronic medication such as corticosteroids, antidepressants, anti-hypertensives; and / or Are pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radmila Razlog, M.Tech Hom
Organizational Affiliation
UJ
Official's Role
Study Chair
Facility Information:
Facility Name
UJ
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 Efficacy of Lacticum Acidum Homaccord in the Treatment of Chronic Tension-type Headaches

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