The Effect of a Homoeopathic Complex on Blood Pressure in Refractory Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Refractory hypertension is defined as failure to reach goal blood pressure control in
      patients who are adherent to full doses of the appropriate drug regime. Hypertension results
      in 7.6 million deaths annually and 92 million disability adjusted years worldwide, making it
      the number one attributable risk for death throughout the world. Conventional treatment
      involves lifestyle modification and antihypertensive drug therapy; however blood pressure can
      remain uncontrolled despite these treatment options. Previous studies have demonstrated a
      reduction in blood pressure in adults with essential hypertension with the use of various
      homoeopathic complexes. There has been no research done to date on the effect of the
      homoeopathic combination of Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum
      muriaticum 6cH and Scutellaria lateriflora 6cH in adults with refractory hypertension.

      The aim of the study is to investigate the effect of a homoeopathic complex Amylenum nitrosum
      6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH and Scutellaria lateriflora 6cH on blood
      pressure in adults with refractory hypertension, by means of blood pressure readings.
    

Detailed description: 
      This study is a six week, double-blind, placebo-controlled pilot study. Thirty participants,
      aged 35 to 60 years, who have been previously diagnosed by their healthcare provider with
      refractory hypertension, will be recruited by means of purposive sampling. Adverts will be
      placed at the University of Johannesburg (UJ) Doornfontein campus and the Soweto satellite
      clinic Nanga Vutshilo Community Centre.

      Potential participants that respond to the advert will attend an initial consultation and
      will be requested to sign a Participant Information and Consent Form once they agree to
      participate in the study. The medical history and physical examination (including vital
      signs, fundoscopic exam, cardiovascular exam, respiratory exam and urinalysis) will be
      recorded on a Case Form. Blood pressure (BP) readings will be taken on each arm with a manual
      BP cuff, according to standard operating procedures, on the first three consecutive days to
      confirm inclusion into the study. Individuals with secondary organ damage from hypertension
      will be excluded from the study.

      Those participants that qualify for the study will be placed into two groups. One group will
      receive a 50ml bottle of the homoeopathic complex and the other group a 50ml bottle of
      placebo. Participants will receive an Intake Diary, to be completed daily, recording
      compliance and any adverse symptoms or aggravations that may be experienced. Follow-up
      consultations will take place every 7 days and participants will be requested to bring with
      their medication bottles for further assessment of compliance; BP readings will be recorded
      on a data collection form. All participants will be given the Dietary Approaches to Stop
      Hypertension (DASH) eating plan at the end of the study to help control their hypertension.
      Additionally, participants will be given an information leaflet to give to their healthcare
      provider, detailing the study.

      Data will be analysed using the non-parametric methods: inter-group analysis will be
      conducted using SPSS v18 with the Mann-Whitney U-test; intra-group analysis will be done
      using the Friedman and the Wilcoxon-Signed Ranks tests.

      A possible outcome of this study is that the homoeopathic complex will have a normalizing
      effect on BP readings compared to placebo. Regardless of the outcome, this study will
      contribute to our knowledge on the use of homoeopathic complex remedies in the treatment and
      management of refractory hypertension.
    

Intervention name(s): 20% ethanol; Homoeopathic complex
Intervention type(s): Other; Other
Intervention description(s): Unmedicated 20% ethanol.; 20% ethanol medicated with Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrium muriaticum 6cH and Scutellaria lateriflora 6cH.
Other intervention name(s): 20% alcohol
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Refractory hypertension; Homoeopathy; Homoeopathic complex; Amylenum nitrosum 6cH; Crataegus oxyacantha 6cH; Natrum muriaticum 6cH; Scutellaria lateriflora 6cH