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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02154152
Recruitment Status : Unknown
Verified May 2014 by Jyoshna Shivaprasad, Fr Muller Homoeopathic Medical College.
Recruitment status was:  Recruiting
First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Collaborator:
Father Muller Medical College
Information provided by (Responsible Party):
Jyoshna Shivaprasad, Fr Muller Homoeopathic Medical College

Tracking Information
First Submitted Date  ICMJE May 30, 2014
First Posted Date  ICMJE June 3, 2014
Last Update Posted Date June 3, 2014
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study on Causticum 200 Centesimal Potency in Primary Enuresis
Official Title  ICMJE A CLINICAL STUDY TO EVALUATE THE EFFICACY OF CAUSTICUM 200C IN THE TREATMENT OF PRIMARY ENURESIS
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bed Wetting
  • Primary Enuresis
Intervention  ICMJE Drug: Homoeopathic Medicine causticum 200c
Other Name: Potassium Hydrate, Hahnemann's Tinctura Acris Sine Kali
Study Arms  ICMJE 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.
Intervention: Drug: Homoeopathic Medicine causticum 200c
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 2, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2015
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02154152
Other Study ID Numbers  ICMJE enuresishmc
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jyoshna Shivaprasad, Fr Muller Homoeopathic Medical College
Study Sponsor  ICMJE Fr Muller Homoeopathic Medical College
Collaborators  ICMJE Father Muller Medical College
Investigators  ICMJE
Principal Investigator: Jyoshna Shivaprasad, MD (Hom) Father Muller Homoeopathic Medical College
PRS Account Fr Muller Homoeopathic Medical College
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP