The Efficacy of Lacticum Acidum Homaccord in the Treatment of Chronic Tension-type Headaches
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- modified Headache Diary and the Headache Disability Inventory.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
- •bilateral location;
- •pressing/tightening (non-pulsating) quality;
- •mild or moderate intensity,
- •aggravated by normal physical activities such as walking or climbing stairs; and at least one of the characteristics in the following categories: 5.
- •photophobia, phonophobia or mild nausea, and 5.
- •moderate or severe nausea or vomiting ; and
- •Fit eight out of the twelve headache-related symptom criteria for Lacticum acidum .
排除标准
- •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.
研究组 & 干预措施
Lacticum acidum homaccord
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
干预措施: Lacticum acidum homaccord (Other)
Placebo
Unmedicated sucrose pillules, take 5 pillules twice daily for 4 weeks
干预措施: Placebo (Other)
结局指标
主要结局
modified Headache Diary and the Headache Disability Inventory.
时间窗: one month
次要结局
未报告次要终点
研究者
Dr J. Pellow
Dr
University of Johannesburg