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

• ClinicalTrials.gov Identifier: NCT02154152
• Recruitment Status: Unknown
• First Posted: June 3, 2014
• Last Update Posted: June 3, 2014
• Sponsor: Fr Muller Homoeopathic Medical College
• Collaborator: Father Muller Medical College
• Information provided by (Responsible Party): Jyoshna Shivaprasad, Fr Muller Homoeopathic Medical College

Tracking Information

• First Submitted Date: May 30, 2014
• First Posted Date: June 3, 2014
• Last Update Posted Date: June 3, 2014
• Study Start Date: May 2014
• Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Bed Wetting
• Primary Enuresis

Intervention

Drug: Homoeopathic Medicine causticum 200c

Other Name: Potassium Hydrate, Hahnemann's Tinctura Acris Sine Kali

Study Arms

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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 2, 2014): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2015
• Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 15 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT02154152
• Other Study ID Numbers: enuresishmc
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jyoshna Shivaprasad, Fr Muller Homoeopathic Medical College
• Study Sponsor: Fr Muller Homoeopathic Medical College
• Collaborators: Father Muller Medical College

Investigators

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

• PRS Account: Fr Muller Homoeopathic Medical College
• Verification Date: May 2014