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

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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

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.

Condition or disease	Intervention/treatment	Phase
Bed Wetting Primary Enuresis	Drug: Homoeopathic Medicine causticum 200c	Phase 3

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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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A CLINICAL STUDY TO EVALUATE THE EFFICACY OF CAUSTICUM 200C IN THE TREATMENT OF PRIMARY ENURESIS
Study Start Date :	May 2014
Estimated Primary Completion Date :	May 2015
Estimated Study Completion Date :	August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines Potassium Urinary Incontinence

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: Homoeopathic Medicine causticum 200c Other Name: Potassium Hydrate, Hahnemann's Tinctura Acris Sine Kali

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	5 Years to 15 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154152

Contacts

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Contact: Jyoshna Shivaprasad, MD (Hom)	919342231894	jyoshnashiv@gmail.com
Contact: Revan B L, MD (Hom)	919972413324	drrevan@hotmail.com

Locations

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India
Father Muller Homoeopathic Medical College	Recruiting
Mangalore, Karnataka, India, 575018
Principal Investigator: Jyoshna Shivaprasad, BHMS, MD (Hom)

Sponsors and Collaborators

Fr Muller Homoeopathic Medical College

Father Muller Medical College

Investigators

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

More Information

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Responsible Party:	Jyoshna Shivaprasad, Dr Jyoshna Shivaprasad, Fr Muller Homoeopathic Medical College
ClinicalTrials.gov Identifier:	NCT02154152
Other Study ID Numbers:	enuresishmc
First Posted:	June 3, 2014 Key Record Dates
Last Update Posted:	June 3, 2014
Last Verified:	May 2014

Keywords provided by Jyoshna Shivaprasad, Fr Muller Homoeopathic Medical College:


Bed wetting Primary Enuresis Frequency	Efficacy Homoeopathic Medicine Causticum 200c

Additional relevant MeSH terms:

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Enuresis Urinary Incontinence Nocturnal Enuresis Urination Disorders Urologic Diseases	Behavioral Symptoms Elimination Disorders Mental Disorders Lower Urinary Tract Symptoms Urological Manifestations

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