Clinical trial NCT02154152: A Clinical Study on Causticum 200 Centesimal Potency in Primary Enuresis
Official title: A CLINICAL STUDY TO EVALUATE THE EFFICACY OF CAUSTICUM 200C IN THE TREATMENT OF PRIMARY ENURESIS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bed Wetting
Primary Enuresis
Keywords: Bed wetting
Primary Enuresis
Frequency
Efficacy
Homoeopathic Medicine
Causticum 200c
Lead sponsor: Fr Muller Homoeopathic Medical College
Sponsor class: OTHER
Collaborators: name: Father Muller Medical College
First posted: 2014-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Bring down frequency of bed wetting
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Mangalore
country: India
facility: Father Muller Homoeopathic Medical College
state: Karnataka
Study officials:
affiliation: Father Muller Homoeopathic Medical College
name: Jyoshna Shivaprasad, MD (Hom)
role: PRINCIPAL_INVESTIGATOR
References: