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

NCT02138474 | Completed Phase 2 DMC

• 2 other identifiers: Maimela200904978Maimela
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Tension-type Headaches

Keywords

Lacticum acidum homaccord; homeopathy; chronic tension-type headaches

Outcome Measures

Primary Outcomes (1)

• modified Headache Diary and the Headache Disability Inventory.

  one month

Study Arms (2)

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

Other: Lacticum acidum homaccord

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Lacticum acidum homaccord OTHER

Homeopathic remedy, made using sucrose pillules

Lacticum acidum homaccord

Placebo OTHER

Unmedicated sucrose pillules

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Johannesburg: lead

Study Sites (1)

UJ

Johannesburg, Gauteng, 2028, South Africa

Location

Study Officials

• Radmila Razlog, M.Tech Hom

  UJ

  STUDY CHAIR

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: May 12, 2014
• First Posted: May 14, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 17, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)