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

Primary Purpose

Bed Wetting, Primary Enuresis

Status
Unknown status
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Homoeopathic Medicine causticum 200c
Sponsored by
Fr Muller Homoeopathic Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bed Wetting focused on measuring Bed wetting, Primary Enuresis, Frequency, Efficacy, Homoeopathic Medicine, Causticum 200c

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Father Muller Homoeopathic Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Homoeopathic Medicine Causticum

Arm Description

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.

Outcomes

Primary Outcome Measures

Bring down frequency of bed wetting
The patients with nocturnal enuresis will receive causticum 200c on weekly basis and results expected by one month.

Secondary Outcome Measures

Full Information

First Posted
May 30, 2014
Last Updated
June 2, 2014
Sponsor
Fr Muller Homoeopathic Medical College
Collaborators
Father Muller Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT02154152
Brief Title
A Clinical Study on Causticum 200 Centesimal Potency in Primary Enuresis
Acronym
PE
Official Title
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF CAUSTICUM 200C IN THE TREATMENT OF PRIMARY ENURESIS
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fr Muller Homoeopathic Medical College
Collaborators
Father Muller Medical College

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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: 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: Frequency of Enuresis Odor of urine Diurnal and Nocturnal urination 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bed Wetting, Primary Enuresis
Keywords
Bed wetting, Primary Enuresis, Frequency, Efficacy, Homoeopathic Medicine, Causticum 200c

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Homoeopathic Medicine Causticum
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Homoeopathic Medicine causticum 200c
Other Intervention Name(s)
Potassium Hydrate, Hahnemann's Tinctura Acris Sine Kali
Primary Outcome Measure Information:
Title
Bring down frequency of bed wetting
Description
The patients with nocturnal enuresis will receive causticum 200c on weekly basis and results expected by one month.
Time Frame
1month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jyoshna Shivaprasad, MD (Hom)
Phone
919342231894
Email
jyoshnashiv@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Revan B L, MD (Hom)
Phone
919972413324
Email
drrevan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyoshna Shivaprasad, MD (Hom)
Organizational Affiliation
Father Muller Homoeopathic Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Father Muller Homoeopathic Medical College
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575018
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jyoshna Shivaprasad, BHMS, MD (Hom)

12. IPD Sharing Statement

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A Clinical Study on Causticum 200 Centesimal Potency in Primary Enuresis

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