Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension

This study has been completed.
Sponsor:
Collaborator:
Rajiv Gandhi University of Health Sciences, Karnataka
Information provided by (Responsible Party):
Dr Kurian P J, Fr Muller Homoeopathic Medical College
ClinicalTrials.gov Identifier:
NCT01527760
First received: February 3, 2012
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

To estimate the effectiveness of Viscum album Homoeopathic mother tincture in Essential Hypertension by conducting clinical trial in moderate hypertensive patients for a period of six weeks.


Condition Intervention
Hypertension
Drug: Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension. One Group Pretest Posttest Design

Resource links provided by NLM:


Further study details as provided by Fr Muller Homoeopathic Medical College:

Primary Outcome Measures:
  • Change in Systolic and Diastolic blood pressure. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Serum Cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Serum Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Serum LDH [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change in Serum Urea [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • change in Serum CKMB [ Time Frame: 12 weeks and 16 weeks ] [ Designated as safety issue: Yes ]
    The blood sample was collected at the end of 12 weeks of medication followed by a drug free period of 4 weeks.The blood sample was collected again at the end of 4 weeks of drug free period to ascertain serum CKMB.


Enrollment: 37
Study Start Date: February 2011
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.)
    Ten drops of Drug in 30 ml of distilled water with a frequency of three times a day for a duration of 12 weeks
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertension at the range 180-120 mm of Hg for Systole &
  • 110-80 mm of Hg for Diastole

Exclusion Criteria:

  • Patients who are on ACEI / ARB for Hypertension
  • Diseases in which life expectancy is less than six months
  • Secondary hypertension
  • CHD
  • Family History of Mental Illness like Anxiety or depression.
  • Nasal Congestion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527760

Locations
India
Fr Muller Homoeopathic Medical College Hospital
Mangalore, Karnataka, India, 575018
Sponsors and Collaborators
Fr Muller Homoeopathic Medical College
Rajiv Gandhi University of Health Sciences, Karnataka
Investigators
Principal Investigator: Dr Kurian P John, MD Fr Muller Homoeopathic Medical College
  More Information

No publications provided by Fr Muller Homoeopathic Medical College

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Kurian P J, Lecturer, Fr Muller Homoeopathic Medical College
ClinicalTrials.gov Identifier: NCT01527760     History of Changes
Other Study ID Numbers: RGUHS2010
Study First Received: February 3, 2012
Last Updated: February 14, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Fr Muller Homoeopathic Medical College:
Essential Hypertension
Viscum album mother tincture
one group pretest post-test study

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014