A Clinical Study on Causticum 200 Centesimal Potency in Primary Enuresis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bed Wetting, Primary Enuresis

Intervention / Treatment
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* Drug: Homoeopathic Medicine causticum 200c


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homoeopathic Medicine Causticum<br>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<br> <br> * Other names: Potassium Hydrate, Hahnemann's Tinctura Acris Sine Kali;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bed wetting, Primary Enuresis, Frequency, Efficacy, Homoeopathic Medicine, Causticum 200c