A Clinical Study on Causticum 200 Centesimal Potency in Primary Enuresis (PE)

June 2, 2014 updated by: Jyoshna Shivaprasad, Fr Muller Homoeopathic Medical College

A CLINICAL STUDY TO EVALUATE THE EFFICACY OF CAUSTICUM 200C IN THE TREATMENT OF PRIMARY ENURESIS

Homeopathic Medicine Causticum 200c will be prescribed in cases of Primary Enuresis on the basis of available symptoms for a period of one year and the results will be evaluated at the end of the given period and efficacy of the drug will be assessed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A CLINICAL STUDY TO EVALUATE THE EFFICACY OF CAUSTICUM 200C IN THE TREATMENT OF PRIMARY ENURESIS

AIMS & OBJECTIVES:

To assess and evaluate the efficacy of administering the Homoeopathic remedy Causticum 200 Centesimal potency based on Homoeopathic principles in management of Primary enuresis A total number of 30 cases will be selected after screening 50 cases as per the inclusion criteria from the Outpatient Department of Father Muller Homoeopathic Medical College for the study and will be followed for a period of one year.

Inclusion criteria:

  1. Age group between 5-15 yrs
  2. Both sexes are included
  3. Patients with Primary enuresis will be Included
  4. Patients with Nocturnal or Diurnal enuresis will be included

Exclusion criteria:

1 Patients with metabolic illness like Diabetes Mellitus or Diabetes Insipidus will be excluded 2. Congenital anomalies like horse shoe kidney, polycystic kidney will be excluded.

3. Presence of Malignancy, Mental Retardation and Cerebral palsy will be excluded.

The case shall be analyzed and prescribed the remedy Causticum in 200 Centesimal potency, 4 globules once a week for 3 months with placebo to follow for the next few months and general management.

RESEARCH PLAN:

Purposive sampling will be followed in the study wherein patients who belong to the above category of Inclusion criteria will be taken up and subjected to screening so as to confirm the diagnosis of Enuresis.

Each patient will be treated for one year with Causticum 200C in the first 3 months along with placebo to follow and attended to, once a week. At each follow-up they will be assessed clinically for evaluating the improvement status.

The drug namely Causticum 200C potency will be ordered from Father Muller Homoeopathic Pharmaceutical division, which complies with the standards of Homoeopathic Pharmacopeia of India. The dosage shall be 4 globules prescribed once a week for 3 months with placebo to follow for the remaining period. This medicine shall be advised half an hour before food.

RESEARCH METHODOLOGY AND STATISTICS:

Criteria for deciding the Efficacy of Homoeopathic medicine Causticum200C shall be based on the following parameters:

  1. Frequency of Enuresis
  2. Odor of urine
  3. Diurnal and Nocturnal urination
  4. Modalities

PLAN FOR ANALYSIS: The collected data will be analyzed by paired 't' test to determine the efficiency.

RESEARCH HYPOTHESIS: There is significant improvement among Primary Enuresis cases in Paediatric age group after prescribing the Homoeopathic drug Causticum 200C.

NULL HYPOTHESIS: There is no significant improvement among Primary Enuresis cases in Paediatric age group after prescribing the Homoeopathic drug Causticum 200C.

ALTERNATIVE HYPOTHESIS: Significant variation in the above parameters before and after treatment.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Karnataka
      • Mangalore, Karnataka, India, 575018
        • Recruiting
        • Father Muller Homoeopathic Medical College
        • Principal Investigator:
          • Jyoshna Shivaprasad, BHMS, MD (Hom)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Age group between 5-15 yrs

    • Both sexes are included
    • Patients with Primary enuresis will be Included
    • Patients with Nocturnal or Diurnal enuresis will be included

Exclusion Criteria:

  • •Patients with metabolic illness like Diabetes Mellitus or Diabetes Insipidus will be excluded

    • Congenital anomalies like horse shoe kidney, polycystic kidney will be excluded.
    • Presence of Malignancy, Mental Retardation and Cerebral palsy will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Homoeopathic Medicine Causticum
The drug namely Causticum 200C potency shall be administered as 4 globules, prescribed once a week for 3 months with placebo to follow for the remaining period.
Drug: Homoeopathic Medicine causticum 200c
Other Names:
  • Potassium Hydrate, Hahnemann's Tinctura Acris Sine Kali

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bring down frequency of bed wetting
Time Frame: 1month
The patients with nocturnal enuresis will receive causticum 200c on weekly basis and results expected by one month.
1month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fr Muller Homoeopathic Medical College

Collaborators

Father Muller Medical College

Investigators

  • Principal Investigator: Jyoshna Shivaprasad, MD (Hom), Father Muller Homoeopathic Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

May 30, 2014

First Submitted That Met QC Criteria

June 2, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Estimate)

June 3, 2014

Last Update Submitted That Met QC Criteria

June 2, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • enuresishmc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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