search
Back to results

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

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.)
Sponsored by
Fr Muller Homoeopathic Medical College
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Essential Hypertension, Viscum album mother tincture, one group pretest post-test study

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fr Muller Homoeopathic Medical College Hospital

Outcomes

Primary Outcome Measures

Change in Systolic and Diastolic blood pressure.

Secondary Outcome Measures

Change in Serum Cholesterol
Change in Serum Triglycerides
Change in Serum LDH
Change in Serum Urea
change in Serum CKMB
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.

Full Information

First Posted
February 3, 2012
Last Updated
February 14, 2012
Sponsor
Fr Muller Homoeopathic Medical College
Collaborators
Rajiv Gandhi University of Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01527760
Brief Title
Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension
Official Title
Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension. One Group Pretest Posttest Design
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fr Muller Homoeopathic Medical College
Collaborators
Rajiv Gandhi University of Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Essential Hypertension, Viscum album mother tincture, one group pretest post-test study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.)
Intervention Description
Ten drops of Drug in 30 ml of distilled water with a frequency of three times a day for a duration of 12 weeks
Primary Outcome Measure Information:
Title
Change in Systolic and Diastolic blood pressure.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Serum Cholesterol
Time Frame
12 weeks
Title
Change in Serum Triglycerides
Time Frame
12 weeks
Title
Change in Serum LDH
Time Frame
12 weeks
Title
Change in Serum Urea
Time Frame
12 weeks
Title
change in Serum CKMB
Description
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.
Time Frame
12 weeks and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Kurian P John, MD
Organizational Affiliation
Fr Muller Homoeopathic Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fr Muller Homoeopathic Medical College Hospital
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575018
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
24647376
Citation
Poruthukaren KJ, Palatty PL, Baliga MS, Suresh S. Clinical evaluation of Viscum album mother tincture as an antihypertensive: a pilot study. J Evid Based Complementary Altern Med. 2014 Jan;19(1):31-5. doi: 10.1177/2156587213507726. Epub 2013 Nov 5.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs