Chronic Tension-type HeadachesPhase 2NCT02138474
The Efficacy of Lacticum Acidum Homaccord in the Treatment of Chronic Tension-type Headaches
A Phase 2 study testing Lacticum acidum homaccord in people with Chronic Tension-type Headaches, run by University of Johannesburg at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Tension-type Headaches
- What is being tested?
- Lacticum acidum homaccord
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2014to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Tension-type Headaches
- Being tested
- Lacticum acidum homaccord, Placebo
- Keywords
- Lacticum acidum homaccord, homeopathy, chronic tension-type headaches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacticum acidum homaccordOther
Homeopathic remedy, made using sucrose pillules
PlaceboOther
Unmedicated sucrose pillules
| Study group | Role | What they receive |
|---|---|---|
| Lacticum acidum homaccord | Experimental | 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 Receives: Other: Lacticum acidum homaccord |
| Placebo | Placebo comparator | Unmedicated sucrose pillules, take 5 pillules twice daily for 4 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Headache Diary and the Headache Disability Inventory.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Tension-type HeadachesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Johannesburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr J. Pellow, University of Johannesburg
- Investigators
- Radmila Razlog, M.Tech Hom, Study chair, UJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138474
- Sponsor's protocol ID
- Maimela200904978
- Other IDs
- Maimela
- Status last verified
- May 2016
- First submitted
- 12 May 2014
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Lacticum Acidum Homaccord in the Treatment of Chronic Tension-type Headaches
- ClinicalTrials.gov ID
- NCT02138474
- Acronym / sponsor ID
- Maimela200904978
- Conditions
- Chronic Tension-type Headaches
- Keywords
- Lacticum acidum homaccord, homeopathy, chronic tension-type headaches
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of JohannesburgUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lacticum acidum homaccord | Experimental | Other: Lacticum acidum homaccordLacticum 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 |
| Placebo | Placebo comparator | Other: PlaceboUnmedicated sucrose pillules, take 5 pillules twice daily for 4 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacticum acidum homaccordHomeopathic remedy, made using sucrose pillules | Other | Lacticum acidum homaccord |
| PlaceboUnmedicated sucrose pillules | Other | Placebo |
Primary outcome
modified Headache Diary and the Headache Disability Inventory.
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radmila Razlog, M.Tech Hom study chair
UJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lacticum acidum homaccord in people with Chronic Tension-type Headaches, run by University of Johannesburg at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Headache Diary and the Headache Disability Inventory. (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.