NCT01527760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
Last Updated

February 16, 2012

Status Verified

February 1, 2012

Enrollment Period

6 months

First QC Date

February 3, 2012

Last Update Submit

February 14, 2012

Conditions

Hypertension

Keywords

Essential HypertensionViscum album mother tinctureone group pretest post-test study

Outcome Measures

Primary Outcomes (1)

  • Change in Systolic and Diastolic blood pressure.

    12 weeks

Secondary Outcomes (5)

  • Change in Serum Cholesterol

    12 weeks

  • Change in Serum Triglycerides

    12 weeks

  • Change in Serum LDH

    12 weeks

  • Change in Serum Urea

    12 weeks

  • change in Serum CKMB

    12 weeks and 16 weeks

Interventions

Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.)DRUG

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 Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fr Muller Homoeopathic Medical College Hospital

Mangalore, Karnataka, 575018, India

Location

Related Publications (1)

  • 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.

    PMID: 24647376DERIVED

MeSH Terms

Conditions

HypertensionEssential Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Dr Kurian P John, MD

    Fr Muller Homoeopathic Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 3, 2012

First Posted

February 7, 2012

Study Start

February 1, 2011

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

February 16, 2012

Record last verified: 2012-02

Locations

IN(1)